A Global Study Testing the New Drug Olverembatinib combined with chemotherapy for Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (POLARIS-1)

2024-511496-14-00 Protocol HQP1351AG301 Therapeutic confirmatory (Phase III) Authorised, recruiting

Start 14 May 2026 · Status Authorised, recruiting · 7 EU/EEA countries · 39 sites · Protocol HQP1351AG301

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Authorised, recruiting
Participants planned 295
Countries 7
Sites 39

Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

Part 1: To assess the efficacy of olverembatinib plus chemotherapy in newly diagnosed Ph+ ALL patients. Part 2: To assess the efficacy of olverembatinib plus chemotherapy versus investigator’s choice of TKI plus chemotherapy in patients with newly diagnosed Ph+ ALL. The primary endpoint is minimal residual disease (MRD…

Key facts

Sponsor
Ascentage Pharma Group Inc.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04], Diseases [C] - Hemic and Lymphatic Diseases [C15]
Trial duration
14 May 2026 → ongoing
Decision date (initial)
2025-07-07
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Ascentage Pharma Group Inc.

External identifiers

EU CT number
2024-511496-14-00
ClinicalTrials.gov
NCT06051409

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

Part 1: To assess the efficacy of olverembatinib plus chemotherapy in newly diagnosed Ph+ ALL patients.
Part 2: To assess the efficacy of olverembatinib plus chemotherapy versus investigator’s choice of TKI plus chemotherapy in patients with newly diagnosed Ph+ ALL. The primary endpoint is minimal residual disease (MRD)-negative complete response (CR) rate at the end of induction.

Secondary objectives 8

  1. Part 1:To assess the pharmacokinetic (PK) profile of olverembatinib plus chemotherapy in patients with newly diagnosed Ph+ ALL.
  2. To assess the safety of olverembatinib plus chemotherapy in patients with newly diagnosed Ph+ ALL.
  3. Part 2: To assess the efficacy of olverembatinib plus chemotherapy versus investigator’s choice of TKI plus chemotherapy in patients with newly diagnosed Ph+ ALL. The key secondary efficacy endpoint is event free survival (EFS).
  4. To further assess the efficacy of olverembatinib plus chemotherapy versus investigator’s choice of TKI plus chemotherapy through various parameters.
  5. To compare the safety of olverembatinib plus chemotherapy with investigator’s choice of TKI plus chemotherapy
  6. To characterize the population PK of olverembatinib in combination with chemotherapy in patients with Ph+ ALL.
  7. To evaluate Patient-Reported Outcome (PRO) measures of olverembatinib plus chemotherapy with investigator’s choice of TKI plus chemotherapy based on Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu).
  8. To evaluate Health Economics Outcomes Research (HEOR) measures of olverembatinib plus chemotherapy with investigator’s choice of TKI plus chemotherapy based on Europol 5 Dimension (EQ-5D).

Conditions and MedDRA coding

Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

Study design 2 periods

#TitleAllocationBlindingRoles blindedArms
1 Part 1
Part 1 aims to assess the efficacy and safety of olverembatinib plus chemotherapy in Arm A (olverembatinib plus vincristine and dexamethasone [VD]) and Arm B (olverembatinib plus daunorubicin, vincristine and dexamethasone [VDP]).
 Randomised Controlled None Part A: olverembatinib plus vincristine and dexamethasone
Part B: olverembatinib plus daunorubicin, vincristine and dexamethasone
2 Part 2
Part 2 is a registrational phase 3 study which is designed to compare the efficacy and safety between Arm A (olverembatinib in combination with VD) and Arm B (investigator’s choice of TKI in combination with VD).
 Randomised Controlled None Part A: olverembatinib in combination with vincristine and dexamethasone
Part B: investigator’s choice of tyrosine kinase inhibitor in combination with vincristine and dexamethasone

Regulatory references

Scientific advice from competent authorities
European Medicines Agency
Plan to share IPD
No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

  1. ≥ 18 years old.
  2. Meet 2016 WHO classification and diagnostic criteria for Philadelphia chromosome- or BCR/ABL1-positive Ph+ ALL. Patients must be newly diagnosed with Ph+ ALL and haven't received systemic anti-leukaemia therapy previously, except for hydroxycarbamide treatment, vincristine treatment no more than once, and steroids therapy for no more than 28 days.
  3. Life expectancy of ≥ 3 months.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  5. Adequate organ function as indicated below: • Hepatic function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × Upper Limit of Normal (ULN), serum total bilirubin ≤ 1.5 × ULN (and for patients with Gilbert’s syndrome serum total bilirubin ≤ 3.0 x ULN); • Renal function: Serum creatinine ≤ 1.5 × ULN; or 24 h creatinine clearance (CrCL) must be ≥ 50 mL/min (Cockcroft-Gault formula) when serum creatinine is > 1.5 × ULN; • Coagulation: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) all ≤ 1.5 × ULN; • Cardiac function index: Left ventricular ejection fraction (LVEF) > 50%; • Troponin I or T ≤ ULN; • QT interval corrected using the Fridericia's formula (QTcF) on electrocardiogram (ECG): QTcF ≤ 450 ms in males or ≤ 470 ms in females.
  6. Males and females of childbearing potential (only postmenopausal women who have not menstruated for at least 12 months or are surgically sterilized can be considered infertile) and their partners voluntarily take effective contraceptive measures throughout the treatment and until at least 4 months after the last dose of the study drug. Male patients are not allowed to donate sperm.
  7. Female patients of childbearing potential have negative serum pregnancy test results within 7 days prior to the first dose
  8. Patients must be able to understand and voluntarily sign a written informed consent form that has been approved by the Ethics Committee (EC) and voluntarily complete study procedures and follow-up examinations

Exclusion criteria 20

  1. Prior history of chronic myelocytic leukemia and diagnosis of chronic myelocytic leukemia in lymphoid blast phase (BP)
  2. Clinical manifestations of central nervous system (CNS) leukemia or ALL extramedullary infiltration, except lymphadenopathy or hepatosplenomegaly
  3. Previous or current clinical CNS diseases, e.g., epilepsy, epileptic seizure of children or adults, paresis, alogia, apoplexy, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or mental aberration
  4. Autoimmune disorders that may involve CNS.
  5. Use of anticoagulants and/or antiplatelet drugs at therapeutic doses, but those using low-dose anticoagulants for keeping the central line patent are acceptable.
  6. Use of a drug for other concomitant diseases which interacts with the study drug (e.g., strong CYP2C9 inducers or inhibitors and moderate to strong CYP3A4 inducers or inhibitors) within 7 days or 5 half-lives prior to the first dose (whichever is shorter).
  7. Presence of any of the following heart injuries at screening: a. New York Heart Association (NYHA) Class III to IV; b. Uncontrolled angina, congestive cardiac failure or myocardial infarction within 6 months prior to the first dose; c. Second-degree type II, third-degree atrioventricular (AV) block or PR interval > 250 ms, etc.; d. Various factors that have a potential to increase the risk of prolonged QTcF or arrhythmia, such as cardiac failure, hypopotassaemia, congenital long QT syndrome, and a family history of sudden death of unknown cause before the age of 40 years in a first-degree relative;
  8. Any venous thromboembolism within 6 months before randomization, including but not limited to deep vein thrombosis (DVT) or lung embolism
  9. Use of prohibited drugs within 7 days or 5 half-lives prior to the first dose (whichever is shorter);
  10. Any disease or medical condition that is unstable or might affect the patient’s safety or study compliance, such as uncontrolled hypertension, uncontrolled diabetes mellitus, active hemorrhage (within 3 months), severe respiratory system disorder (e.g., chronic obstructive pulmonary disease, severe asthma, etc.), significant renal, nervous, endocrine, metabolic, immune, hepatic, digestive diseases, and mental diseases, etc.
  11. Use of drugs that are known to possibly cause prolonged ECG QT
  12. Active fungal/bacterial/viral infection that requires systemic treatment, including but not limited to human immunodeficiency virus (HIV), active viral hepatitis B and hepatitis C, known active COVID-19 (those who have received COVID-19 vaccine or other attenuated live vaccine more than 28 days before enrollment are acceptable).
  13. Diseases seriously affect oral administration and absorption of drugs or those who have active peptic ulcer
  14. Contraindications to glucocorticoids and unsuitable for participating in the study, at the discretion of the investigator
  15. Hemorrhagic disorder unrelated to the tumor: such as congenital hemorrhagic disorder (e.g., angiohaemophilia von Willebrand disease), acquired hemorrhagic disorder diagnosed within 1 year (e.g., acquired factor VIII inhibitor), etc.
  16. A major surgery within 14 days prior to the first dose of the study drug (except for minor surgeries such as bone marrow biopsy and deep vein catheterization) or those who haven’t fully recovered from previous surgeries, at the discretion of the investigator.
  17. Hypersensitivity to ingredients, excipients or analogues of drugs used in the study
  18. Females who are pregnant, breastfeeding, or planning to become pregnant during the study or within 4 months of Olverembatinib after the last dose
  19. Other malignancies within 2 years prior to enrollment, with the exception of: adequately treated cervical carcinoma in situ or breast carcinoma in situ; completely excised skin basal cell carcinoma or localized squamous cell carcinoma of the skin. It is necessary to discuss with the Sponsor for patients with a history of localized malignancy that has been cured by excision (or other methods) which will not affect safety and efficacy evaluation of the study, at the discretion of the investigator.
  20. Any symptom or disease that may compromise patients' safety or interfere with the efficacy and safety assessment of the study drug, or any other situation or condition unsuitable for participating in the study. In special circumstances, a decision will be made after the investigator discusses with the Sponsor

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

  1. MRD-negative CR rate at the end of induction (EOI): MRD-negativity is defined as BCR-ABL/ABL1 ≤ 0.01% measured centrally by reverse transcription qPCR. CR is defined as meeting the following criteria: ①No circulating blasts; No extramedullary disease (i.e., no lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass or CNS involvement);
  2. Normal maturation of all cellular components in the BM and less than 5% blasts in the bone marrow;
  3. absolute neutrophil count (ANC) ≥ 1.0 × 109/L
  4. platelet counts ≥ 100 × 109/L
  5. no relapse within 4 weeks

Secondary endpoints 10

  1. Event‑free survival (EFS): EFS is the key secondary endpoint. EFS is defined as the time from study randomization to the date of treatment failure (ITF), relapse from CR, or death from any cause, whichever comes first. ITF is defined as failure to achieve CR during induction period (i.e., considering CRi responses treatment failures).
  2. Overall response rate (ORR): ORR is defined as complete response (CR), CR with partial hematologic recovery (CRh) and CR with incomplete hematologic recovery (CRi). (1) CRh is defined as hematologic complete remission with partial hematologic recovery and meeting all criteria for CR except platelet count and ANC (ANC > 0.5 × 109/L and platelet counts > 50 × 109/L)
  3. CRi is defined as hematologic complete remission with incomplete hematologic recovery and meeting all criteria for CR except platelet count or ANC (platelet counts < 100 × 109/L and ANC ≥ 1.0 × 109/L, or platelet counts ≥ 100 × 109/L and ANC < 1.0 × 109/L)
  4. Duration of MRD-negative CR: The interval from the date when MRD-negative CR criteria are first met upon evaluation to the date of molecular relapse from MRD-negativity, or relapse after CR, or to the date of leukemia-related death.
  5. Duration of CR, CRh or CRi: The interval from the date when CR, CRh, or CRi criteria are first met upon evaluation to the earliest date of relapse after CR, CRh or CRi.
  6. Time to MRD-negative CR: The interval from the date of randomization to the date when MRD-negative CR first met upon evaluation
  7. Time to CR, CRh or CRi: The interval from the date of randomization to the date when CR, CRh or CRi criteria are first met upon evaluation
  8. Time to treatment failure: The time to discontinuation of randomized study treatment (excluding HSCT performed when MRD-negativity is maintained) for patients due to safety concerns and/or the loss of efficacy benefit
  9. Progression‑free survival (PFS): PFS is defined as the date of randomization to the first documented occurrence of the following events: • Progressive disease: An increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease • Disease relapse: Reappearance of blasts in the blood or bone marrow (>5%) or in any extramedullary site after a CR/CRh/CRi • Death due to any cause
  10. OS: The interval from the date of randomization to the date of death due to any cause (to the last contact date if the patient is still alive).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 10

Cytarabine

SUB06880MIG · Substance

Active substance
Cytarabine
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRATHECAL USE
Max daily dose
50 mg milligram(s)
Max total dose
50 mg milligram(s)
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cytarabine

SUB06880MIG · Substance

Active substance
Cytarabine
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
IV INFUSION
Max daily dose
1 gm/m2 gram(s)/square meter
Max total dose
1 gm/m2 gram(s)/square meter
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vincristine Sulfate

SUB05101MIG · Substance

Active substance
Vincristine Sulfate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
IV INFUSION
Max daily dose
2 mg milligram(s)
Max total dose
2 mg milligram(s)
Max treatment duration
14 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Olverembatinib

PRD11143748 · Product

Active substance
Olverembatinib
Substance synonyms
GZD-824, HQP-1351, 4-methyl-N-(4-((4-methylpiperazin-1-yl)methyl)-3-(trifluoromethyl)phenyl)-3-((1H-pyrazolo(3,4-b)pyridin-5-yl)ethynyl)benzamide, D-824
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
40 mg milligram(s)
Max total dose
40 mg milligram(s)
Max treatment duration
20 Month(s)
Authorisation status
Not Authorised
MA holder
ASCENTAGE PHARMA GROUP INC.
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/21/2530

Dexamethasone

SUB07017MIG · Substance

Active substance
Dexamethasone
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
10 mg milligram(s)
Max total dose
10 mg milligram(s)
Max treatment duration
3 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dexamethasone

SUB07017MIG · Substance

Active substance
Dexamethasone
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
10 mg milligram(s)
Max total dose
10 mg milligram(s)
Max treatment duration
3 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dexamethasone

SUB07017MIG · Substance

Active substance
Dexamethasone
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS ADMINISTRATION
Max daily dose
10 mg milligram(s)
Max total dose
10 mg milligram(s)
Max treatment duration
3 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Methotrexate

SUB08856MIG · Substance

Active substance
Methotrexate
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRATHECAL USE
Max daily dose
1 mg milligram(s)
Max total dose
1 mg milligram(s)
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Methotrexate

SUB08856MIG · Substance

Active substance
Methotrexate
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
1000 µg/ m2 microgram(s)/ sq. Meter
Max total dose
1000 µg/ m2 microgram(s)/ sq. Meter
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Prednisolone

SUB10018MIG · Substance

Active substance
Prednisolone
Pharmaceutical form
SOLUBLE TABLET
Route of administration
ORAL
Max daily dose
50 mg milligram(s)
Max total dose
50 mg milligram(s)
Max treatment duration
11 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 13

Vincristine Sulfate

SUB05101MIG · Substance

Active substance
Vincristine Sulfate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
IV INFUSION
Max daily dose
2 mg milligram(s)
Max total dose
2 mg milligram(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dasatinib

SUB23322 · Substance

Active substance
Dasatinib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
140 mg milligram(s)
Max total dose
140 mg milligram(s)
Max treatment duration
20 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
The product has MA in EU but not for Newly Diagnosed Ph+ ALL

Dexamethasone

SUB07017MIG · Substance

Active substance
Dexamethasone
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS ADMINISTRATION
Max daily dose
10 mg milligram(s)
Max total dose
10 mg milligram(s)
Max treatment duration
3 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dexamethasone

SUB07017MIG · Substance

Active substance
Dexamethasone
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
10 mg milligram(s)
Max total dose
10 mg milligram(s)
Max treatment duration
3 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dexamethasone

SUB07017MIG · Substance

Active substance
Dexamethasone
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
10 mg milligram(s)
Max total dose
10 mg milligram(s)
Max treatment duration
3 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dasatinib

SUB23322 · Substance

Active substance
Dasatinib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
140 mg milligram(s)
Max total dose
140 mg milligram(s)
Max treatment duration
20 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
The product has MA in EU but not for Newly Diagnosed Ph+ ALL

Imatinib Mesilate

SUB12517MIG · Substance

Active substance
Imatinib Mesilate
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
600 mg milligram(s)
Max total dose
600 mg milligram(s)
Max treatment duration
20 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
The product has MA in EU but not for Newly Diagnosed Ph+ ALL in adults

Ponatinib

SUB91901 · Substance

Active substance
Ponatinib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
30 mg milligram(s)
Max total dose
30 mg milligram(s)
Max treatment duration
20 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
The product has MA in EU but not for Newly Diagnosed Ph+ ALL

Methotrexate

SUB08856MIG · Substance

Active substance
Methotrexate
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
1 µg/ m2 microgram(s)/ sq. Meter
Max total dose
1 µg/ m2 microgram(s)/ sq. Meter
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Methotrexate

SUB08856MIG · Substance

Active substance
Methotrexate
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRATHECAL USE
Max daily dose
1 mg milligram(s)
Max total dose
1 mg milligram(s)
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cytarabine

SUB06880MIG · Substance

Active substance
Cytarabine
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
IV INFUSION
Max daily dose
1 gm/m2 gram(s)/square meter
Max total dose
1 gm/m2 gram(s)/square meter
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cytarabine

SUB06880MIG · Substance

Active substance
Cytarabine
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRATHECAL USE
Max daily dose
50 mg milligram(s)
Max total dose
50 mg milligram(s)
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Prednisolone

SUB10018MIG · Substance

Active substance
Prednisolone
Pharmaceutical form
SOLUBLE TABLET
Route of administration
ORAL
Max daily dose
50 mg milligram(s)
Max total dose
50 mg milligram(s)
Max treatment duration
11 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Ascentage Pharma Group Inc.

7 Total trials 6 Recruiting
Commercial
Sponsor organisation
Ascentage Pharma Group Inc.
Address
700 King Farm Boulevard
City
Rockville
Postcode
20850-5736
Country
United States

Scientific contact point

Organisation
Ascentage Pharma Group Inc.
Contact name
Yifan Zhai, M.D., Ph.D.

Public contact point

Organisation
Ascentage Pharma Group Inc.
Contact name
Yifan Zhai, M.D., Ph.D.

Third parties 11

OrganisationCity, countryDuties
Novasco
ORG-100046671
 Paris, France Other
Perceptive Informatics Inc.
ORG-100013171
 Burlington, United States Interactive response technologies (IRT)
Iqvia Biotech Limited
ORG-100008726
 Reading, United Kingdom Code 12, Code 2, Code 5, Code 8
Frontage Laboratories Inc.
ORG-100011515
 Exton, United States Laboratory analysis
Clinchoice Medical (Tianjin) Co. Ltd.
ORG-100053189
 Tianjin, China Data management
Molecularmd Corp.
ORG-100047559
 Portland, United States Other
Almac Clinical Services Limited
ORG-100017464
 Craigavon, United Kingdom (Northern Ireland) Other
Icon Laboratory Services Inc.
ORG-100037135
 Farmingdale, United States Other
Iqvia Biotech LLC
ORG-100008704
 Durham, United States Other
Taxi Travel Ticket S.L.
ORG-100042292
 Barcelona, Spain Other
Icon Laboratory Services Inc.
ORG-100037135
 Farmingdale, United States Laboratory analysis

Locations

7 EU/EEA countries · 39 investigational sites

By country

CountryMS statusPlanned subjectsSites
Bulgaria Ended 4 1
Czechia Authorised, recruitment pending 16 5
France Ongoing, recruiting 11 8
Hungary Not authorised 4 1
Italy Authorised, recruiting 16 8
Romania Authorised, recruitment pending 4 4
Spain Ongoing, recruiting 16 12
Rest of world
Russian Federation, Turkey, Singapore, United Kingdom, Australia, United States, China
 — 224 —

Investigational sites

Bulgaria

1 site · Ended
Specialized Hospital For Active Treatment Of Hematological Diseases EAD
First department of clinical hematology at Clinic of clinical hematology, Bulevard Kliment Ohridski 1a, 1797, Sofiya

Czechia

5 sites · Authorised, recruitment pending
Fakultni Nemocnice Hradec Kralove
IV. interní hematologická klinika, Sokolska 581, Novy Hradec Kralove, Hradec Kralove
Fakultni Nemocnice Ostrava
Klinika hematoonkologie, 17. Listopadu 1790/5, Poruba, Ostrava
Fakultni Nemocnice Kralovske Vinohrady
Hematologická klinika, Srobarova 1150/50, Vinohrady, Prague
Fakultni Nemocnice Brno
Interní hematologická a onkologická klinika, Jihlavska 340/20, Bohunice, Brno
Institute Of Hematology And Blood Transfusion
NA, U Nemocnice 2094/1, Nove Mesto, Prague

France

8 sites · Ongoing, recruiting
Centre Hospitalier De Versailles
Hematology, 177 Rue De Versailles, Le Chesnay, Le Chesnay Rocquencourt
Centre Leon Berard
Medical Oncologist, 28 Rue Laennec, 69008, Lyon
Centre Hospitalier Universitaire De Bordeaux
Hematologist, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Nice
Hematology, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Universitaire De Toulouse
Hematology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Hospices Civils De Lyon
hematology, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Universitaire De Poitiers
Hematology, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire De Nantes
Hematology, 1 Place Alexis Ricordeau, 44000, Nantes

Hungary

1 site · Not authorised
University Of Pecs
Haematology Osztály, Ifjusag Utja 13, 7624, Pecs

Italy

8 sites · Authorised, recruiting
Ospedale San Raffaele S.r.l.
Hematology and Bone Marrow Transplant Unit, Via Olgettina 60, 20132, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Diagnostic Imaging, radiotherapy, oncology and Hematology, Largo Francesco Vito 1, 00168, Rome
Azienda Unita Sanitaria Locale Della Romagna
Unit Oncology and Hematology Department, Viale Vincenzo Randi 5, 48121, Ravenna
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Unit Oncology and Hematology Department, Via Pietro Albertoni 15, 40138, Bologna
Fondazione IRCCS San Gerardo Dei Tintori
Hematology Department, Via Giovanni Battista Pergolesi 33, 20900, Monza
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Division of Hematology, Viale Luigi Borri N 57, 21100, Varese
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department of Oncology, division of Hematology, Corso Bramante 88, 10126, Turin
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Onco Hematology Department, Via Piero Maroncelli 40, 47014, Meldola

Romania

4 sites · Authorised, recruitment pending
Spitalul Clinic Colentina Bucuresti
Hematology, Soseaua Stefan Cel Mare 19-21, 020125, Bucharest
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Hematology, Strada Republicii 34-36, 400015, Cluj-Napoca
Institutul Regional De Oncologie Iasi
Hematology, Strada G-Ral Berthelot 2-4, 700483, Iasi
Spitalul Clinic Municipal Filantropia Craiova
Hematology, Strada Filantropiei No 1, 200143, Craiova

Spain

12 sites · Ongoing, recruiting
Hospital San Pedro De Alcantara
Hematology, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Hospital Universitario Marques De Valdecilla
Hematology, Avenida Valdecilla Sn, 39008, Santander
Institut Catala D'oncologia
Hematology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitari Vall D Hebron
Hematology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario De La Princesa
Hematology, Calle De Diego De Leon 62, 28006, Madrid
University Hospital Virgen Del Rocio S.L.
Hematology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Y Politecnico La Fe
Hematology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Ramon Y Cajal
Hematology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Hematology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Germans Trias I Pujol
Hematology, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitario 12 De Octubre
Hematology, Avenida De Cordoba Sn, 28041, Madrid
Hospital General Universitario Gregorio Maranon
Hematology, Calle Del Doctor Esquerdo 46, 28009, Madrid

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
France 2026-05-14 2026-05-15
Italy 2026-05-26
Spain 2026-05-14 2026-05-15

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 245 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2024-511496-14_GR_Redacted 2.0 EU1
Protocol (for publication) D1_Protocol 2024-511496-14_Redacted 2.0 EU 3
Protocol (for publication) D4_Patient facing document_EQ-5D-5L_BG_Redacted 1.2
Protocol (for publication) D4_Patient facing document_EQ-5D-5L_CZ_Redacted 1.2
Protocol (for publication) D4_Patient facing document_EQ-5D-5L_DE_Redacted 1.2
Protocol (for publication) D4_Patient facing document_EQ-5D-5L_EN_Redacted 1.2
Protocol (for publication) D4_Patient facing document_EQ-5D-5L_ES_Redacted 1.2
Protocol (for publication) D4_Patient facing document_EQ-5D-5L_FR_Redacted 1.2
Protocol (for publication) D4_Patient facing document_EQ-5D-5L_GR_Redacted 1.2
Protocol (for publication) D4_Patient facing document_EQ-5D-5L_HU_Redacted 1.2
Protocol (for publication) D4_Patient facing document_EQ-5D-5L_IT_Redacted 1.2
Protocol (for publication) D4_Patient facing document_EQ-5D-5L_PL_Redacted 1.2
Protocol (for publication) D4_Patient facing document_EQ-5D-5L_RO_Redacted 1.2
Protocol (for publication) D4_Patient facing document_FACT-Leu_BG_Redacted 4.0
Protocol (for publication) D4_Patient facing document_FACT-Leu_CZ_ Redacted 4.0
Protocol (for publication) D4_Patient facing document_FACT-Leu_DE_Redacted 4.0
Protocol (for publication) D4_Patient facing document_FACT-Leu_EN_Redacted 4.0
Protocol (for publication) D4_Patient facing document_FACT-Leu_ES_Redacted 4.0
Protocol (for publication) D4_Patient facing document_FACT-Leu_FR_Redacted 4.0
Protocol (for publication) D4_Patient facing document_FACT-Leu_GR_Redacted 4.0
Protocol (for publication) D4_Patient facing document_FACT-Leu_HU_Redacted 4.0
Protocol (for publication) D4_Patient facing document_FACT-Leu_IT_Redacted 4.0
Protocol (for publication) D4_Patient facing document_FACT-Leu_PL_Redacted 4.0
Protocol (for publication) D4_Patient facing document_FACT-Leu_RO_Redacted 4.0
Protocol (for publication) D4_Patient facing document_ID card_BG 2.1
Protocol (for publication) D4_Patient facing document_ID card_CZ 2.1
Protocol (for publication) D4_Patient facing document_ID card_DE 2.0
Protocol (for publication) D4_Patient facing document_ID card_EN 2.0
Protocol (for publication) D4_Patient facing document_ID card_ES 2.0
Protocol (for publication) D4_Patient facing document_ID card_FR 2.1
Protocol (for publication) D4_Patient facing document_ID card_GR 2.1
Protocol (for publication) D4_Patient facing document_ID card_HU 2.0
Protocol (for publication) D4_Patient facing document_ID card_IT 2.0
Protocol (for publication) D4_Patient facing document_ID card_PL 2.1
Protocol (for publication) D4_Patient facing document_ID card_RO 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Consolidation:C4-9_BG 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Consolidation:C4-9_CZ 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Consolidation:C4-9_DE 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Consolidation:C4-9_EN 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Consolidation:C4-9_ES 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Consolidation:C4-9_FR 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Consolidation:C4-9_GR 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Consolidation:C4-9_HU 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Consolidation:C4-9_IT 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Consolidation:C4-9_PL 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Consolidation:C4-9_RO 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Induction:C1-3_BG 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Induction:C1-3_CZ 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Induction:C1-3_DE 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Induction:C1-3_EN 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Induction:C1-3_ES 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Induction:C1-3_FR 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Induction:C1-3_GR 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Induction:C1-3_HU 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Induction:C1-3_IT 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Induction:C1-3_PL 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Induction:C1-3_RO 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Maintenance:C10-20_BG 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Maintenance:C10-20_CZ 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Maintenance:C10-20_DE 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Maintenance:C10-20_EN 3.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Maintenance:C10-20_ES 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Maintenance:C10-20_FR 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Maintenance:C10-20_GR 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Maintenance:C10-20_HU 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Maintenance:C10-20_IT 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Maintenance:C10-20_PL 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Dasatinib_Maintenance:C10-20_RO 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Consolidation:C4-9_BG 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Consolidation:C4-9_CZ 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Consolidation:C4-9_DE 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Consolidation:C4-9_EN 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Consolidation:C4-9_ES 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Consolidation:C4-9_FR 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Consolidation:C4-9_GR 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Consolidation:C4-9_HU 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Consolidation:C4-9_IT 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Consolidation:C4-9_PL 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Consolidation:C4-9_RO 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Induction:C1-3_BG 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Induction:C1-3_CZ 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Induction:C1-3_DE 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Induction:C1-3_EN 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Induction:C1-3_ES 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Induction:C1-3_FR 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Induction:C1-3_GR 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Induction:C1-3_HU 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Induction:C1-3_IT 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Induction:C1-3_PL 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Induction:C1-3_RO 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Maintenance:C10-20_BG 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Maintenance:C10-20_CZ 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Maintenance:C10-20_DE 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Maintenance:C10-20_EN 4.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Maintenance:C10-20_ES 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Maintenance:C10-20_FR 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Maintenance:C10-20_GR 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Maintenance:C10-20_HU 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Maintenance:C10-20_IT 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Maintenance:C10-20_PL 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Imatinib_Maintenance:C10-20_RO 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Consolidation:C4-9_BG 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Consolidation:C4-9_CZ 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Consolidation:C4-9_DE 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Consolidation:C4-9_EN 3.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Consolidation:C4-9_ES 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Consolidation:C4-9_FR 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Consolidation:C4-9_GR 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Consolidation:C4-9_HU 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Consolidation:C4-9_IT 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Consolidation:C4-9_PL 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Consolidation:C4-9_RO 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Induction:C1-3_BG 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Induction:C1-3_CZ 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Induction:C1-3_DE 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Induction:C1-3_EN 3.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Induction:C1-3_ES 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Induction:C1-3_FR 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Induction:C1-3_GR 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Induction:C1-3_HU 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Induction:C1-3_IT 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Induction:C1-3_PL 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Induction:C1-3_RO 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Maintenance:C10-20_BG 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Maintenance:C10-20_CZ 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Maintenance:C10-20_DE 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Maintenance:C10-20_EN 4.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Maintenance:C10-20_ES 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Maintenance:C10-20_FR 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Maintenance:C10-20_GR 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Maintenance:C10-20_HU 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Maintenance:C10-20_IT 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Maintenance:C10-20_PL 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Olverembatinib_Maintenance:C10-20_RO 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Consolidation:C4-9_BG 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Consolidation:C4-9_CZ 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Consolidation:C4-9_DE 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Consolidation:C4-9_EN 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Consolidation:C4-9_ES 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Consolidation:C4-9_FR 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Consolidation:C4-9_GR 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Consolidation:C4-9_HU 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Consolidation:C4-9_IT 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Consolidation:C4-9_PL 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Consolidation:C4-9_RO 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Induction:C1-3_BG 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Induction:C1-3_CZ 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Induction:C1-3_DE 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Induction:C1-3_EN 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Induction:C1-3_ES 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Induction:C1-3_FR 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Induction:C1-3_GR 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Induction:C1-3_HU 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Induction:C1-3_IT 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Induction:C1-3_PL 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Induction:C1-3_RO 1.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Maintenance:C10-20_BG 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Maintenance:C10-20_CZ 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Maintenance:C10-20_DE 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Maintenance:C10-20_EN 4.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Maintenance:C10-20_ES 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Maintenance:C10-20_FR 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Maintenance:C10-20_GR 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Maintenance:C10-20_HU 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Maintenance:C10-20_IT 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Maintenance:C10-20_PL 2.0
Protocol (for publication) D4_Patient facing document_Patient Diary_Ponatinib_Maintenance:C10-20_RO 2.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_public 2
Recruitment arrangements (for publication) K1_Recruitment arrangements_public 1.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_public 1.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_public 1.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_public 1.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_public 1.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_public 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_ Pregnant Partner_public 3.0ROM2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_ Spain_ Pregnant Partner _ICF_Redacted V3.6.0
Subject information and informed consent form (for publication) L1_SIS and ICF_ Spain_Main_ICF_Redacted 6.7.0
Subject information and informed consent form (for publication) L1_SIS and ICF_ Spain_Pregnancy Pregnant Partner _ICF_public 1.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Combined Pregnancy Pregnant Partner ICF_CL_redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Combined Pregnancy Pregnant Partner ICF_public 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_DPCF_redacted 1.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_CL_redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main Part 2_redacted 6.4.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_public 6.0ROM2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_public 6.0ROMro2.
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_redacted 6.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_redacted 6.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_redacted 6.4.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional Genetic Testing_ICF_redacted 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional Genetic Testing_redacted 1.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnancy Pregnant Partner_redacted 3.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnancy Pregnant Partner_redacted 3.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnancy Pregnant Partner_redacted 3.3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnancy_redacted 2.2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Partner_public 3.0ROMro2.
Subject information and informed consent form (for publication) L1_SIS_and ICF_Main_redacted 6.3.0
Subject information and informed consent form (for publication) L1_SIS_and ICF_Pregnancy_redacted 3.3.0
Subject information and informed consent form (for publication) L1_SIS_and ICF_Privacy_redacted 6.3.0
Subject information and informed consent form (for publication) L2_GP Letter_public 1.0
Subject information and informed consent form (for publication) L2_Patient Card 2
Subject information and informed consent form (for publication) L2_Patient Card_CL_public 3
Summary of Product Characteristics (SmPC) (for publication) E2_Methotrexate_EMA products NA
Summary of Product Characteristics (SmPC) (for publication) E2_Methotrexate_EMA products NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Cytarabine_IE NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Cytarabine_IE NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Dexamethasone 2 mg_IE NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Dexamethasone 2 mg_IE NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Dexamethasone 4 mg_IE NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Dexamethasone 4 mg_IE NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Dexamethasone 500 mcg_IE NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Dexamethasone 500 mcg_IE NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Imatinib NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Imatinib_CH NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Imatinib-CH_EN NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Methotrexate 100mg_IE NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Methotrexate 100mg_IE NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Methotrexate 25mg_IE NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Methotrexate 25mg_IE NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Ponatinib NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Prednisolone 5mg_IE NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Prednisolone 5mg_IE NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Vincristine Sulfate 1mg_ml_IE NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Vincristine Sulfate 1mg_ml_IE NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Zentiva_Dasatinib_DE NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Zentiva_Dasatinib_DE NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Zentiva_Dasatinib_PL NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Zentiva_Dasatinib_PL NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Zentiva_Dasatinib-DE_EN NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Zentiva_Dasatinib-DE_EN NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Zentiva_Dasatinib-PL_EN NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Zentiva_Dasatinib-PL_EN NA
Synopsis of the protocol (for publication) D1_Protocol Lay synopsis_BG_2024-511496-14_Redacted 2.0 EU 3
Synopsis of the protocol (for publication) D1_Protocol Lay synopsis_CZ_2024-511496-14_Redacted 2.0 EU 3
Synopsis of the protocol (for publication) D1_Protocol Lay synopsis_DE_2024-511496-14_Redacted 2.0 EU 2
Synopsis of the protocol (for publication) D1_Protocol Lay synopsis_EN_2024-511496-14_Redacted 2.0 EU 3
Synopsis of the protocol (for publication) D1_Protocol Lay synopsis_ES_2024-511496-14_Redacted 2.0 EU 3
Synopsis of the protocol (for publication) D1_Protocol Lay synopsis_FR_2024-511496-14_Redacted 2.0 EU 3
Synopsis of the protocol (for publication) D1_Protocol Lay synopsis_GR_2024-511496-14_Redacted 2.0 EU 2
Synopsis of the protocol (for publication) D1_Protocol Lay synopsis_HU_2024-511496-14_Redacted 2.0 EU 2
Synopsis of the protocol (for publication) D1_Protocol Lay synopsis_IT_2024-511496-14_Redacted 2.0 EU 3
Synopsis of the protocol (for publication) D1_Protocol Lay synopsis_PL_2024-511496-14_Redacted 2.0 EU 2
Synopsis of the protocol (for publication) D1_Protocol Lay synopsis_RO_2024-511496-14_Redacted 2.0 EU 3
Synopsis of the protocol (for publication) D1_Protocol synopsis_CZ Specific_CZ_2024-511496-14_Redacted 2.0 EU 3
Synopsis of the protocol (for publication) D1_Protocol synopsis_CZ Specific_EN_2024-511496-14_Redacted 2.0 EU 3

Application history

4 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-03-06 France Acceptable
2025-06-30
 2025-07-01
2 SUBSTANTIAL MODIFICATION SM-1 2025-12-09 France Acceptable
2026-03-30
 2026-04-01
3 SUBSTANTIAL MODIFICATION SM-2 2026-04-14 France Acceptable 2026-05-21
4 SUBSTANTIAL MODIFICATION SM-4 2026-05-07 Acceptable 2026-05-18

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