Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
32
Countries
1
Sites
36
Adult Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia.
The primary objective is to evaluate the clinical response - in terms of MRD negativity - in patients with a BCR/ABL1-like profile, according to the BCR/ABL1-like predictor tool, treated with Ponatinib in combination with chemotherapy.
Key facts
- Sponsor
- Fondazione Gimema Franco Mandelli Onlus
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 5 Oct 2022 → ongoing
- Decision date (initial)
- 2024-07-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Incyte Biosciences International Sàrl · Fondazione GIMEMA Franco Mandelli onlus
External identifiers
- EU CT number
- 2023-510240-20-00
- EudraCT number
- 2022-000633-17
- ClinicalTrials.gov
- NCT05306301
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Therapy
The primary objective is to evaluate the clinical response - in terms of MRD negativity - in patients with a BCR/ABL1-like profile, according to the BCR/ABL1-like predictor tool, treated with Ponatinib in combination with chemotherapy.
Secondary objectives 9
- MRD monitoring during the different time points of the study treatment
- Disease Free Survival
- Event Free Survival
- Cumulative Incidence of Relapse
- Overall Survival
- Treatment-related mortality (TRM)
- Clinical response
- Feasibility of a combination approach with Ponatinib and chemotherapy
- Safety
Conditions and MedDRA coding
Adult Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10000845 | Acute lymphoblastic leukemia | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Age18-65 years.
- De novo Ph+-like ALL, as defined by the BCR/ABL1-like predictor (13).
- WHO score =2
- Adequate liver function, as defined by the following criteria: total serum bilirubin =1.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome, alanine aminotransferase (ALT) =2.5 ×ULN or aspartate aminotransferase (AST) =2.5 x ULN or leukemia related.
- Adequate pancreatic function as defined by serum lipase and amylase =1.5 × ULN or leukemia related
- No history of dyslipidemia, thrombotic events or cardiac disease.
- For females of childbearing potential, a negative pregnancy test must be documented. Female and male patients who are fertile must agree to use an effective form of contraception with their sexual partners from enrollment through 12 months after the end of treatment.
- Signed informed consent, according to ICH/EU/GCP and national regulation.
Exclusion criteria 18
- WHO performance status >2.
- Taking any medications or herbal supplements that are known to be strong inhibitors of CYP3A4 within at least 14 days before the first dose of ponatinib.
- Creatinine levels > 2.5mg/dl or glomerular filtration rate (GFR) < 20 ml/min or proteinuria >3.5 g/day.
- Active HBV or HCV hepatitis, or AST/ALT > 2.5 x ULN and bilirubin > 1.5 x ULN.
- History of acute pancreatitis within 1 year of study or history of chronic pancreatitis.
- History of alcohol abuse
- Ongoing or active infections
- Uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL).
- Clinically significant, uncontrolled or active cardiovascular disease, specifically including, but not restricted to: - Any history of myocardial infarction, stroke, or revascularization, unstable angina or transient ischemic attack within 6 months prior to enrollment, - Congestive heart failure within 6 months prior to enrollment, or left ventricular ejection fraction (LVEF) less than lower limit of normal per local institutional standards, - History of clinically significant (as determined by the treating physician) atrial arrhythmia, - Any history of ventricular arrhythmia, - Any history of venous thromboembolism including deep venous thrombosis or pulmonary embolism.
- Uncontrolled hypertension (diastolic blood pressure >90 mm Hg; systolic >140 mm Hg). Patients with hypertension should be under treatment on study entry to effect blood pressure control.
- Taking medications that are known to be associated with torsades de pointes
- Gastrointestinal (GI) function impairment, or a GI disease that may significantly alter the absorption of study drugs.
- Patients who are currently receiving treatment with any of the medications with potential to prolong QT interval (listed in Appendix F) if the medications cannot be either discontinued or switched to a different medication prior to starting study drug
- Patients who have received any investigational drug = 4 weeks.
- Patients who have undergone major surgery = 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
- Patients who are pregnant or breast feeding and adults of reproductive potential not employing an effective method of birth control (women of childbearing potential must have a negative serum pregnancy test within 48 hrs. prior to administration of Ponatinib). Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ two effective reliable methods of birth control throughout the study and for up to 12 months following discontinuation of study drugs
- Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
- Patients unwilling or unable to comply with the protocol
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint of this study is to evaluate clinical response - in terms of MRD negativity rate after 3 cycles (TP2) in patients with BCR/ABL1-like ALL treated with a Ponatinib plus chemotherapy approach.
Secondary endpoints 9
- The rate of MRD negativity at 2 timepoints TP1, TP3
- DFS at 24 months
- EFS at 24 months
- CIR estimation from CR achievement at 24 months
- OS at 24 months
- Treatment-related mortality (TRM)
- Rate of patients in CR after TP2
- Rate of patients who undego transplantion and who complete the Chemotherapy plus ponatinib scheme
- Rate of Adverse Events (AEs) and Seriuos AEs related to Ponatinib
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Iclusig 15 mg film-coated tablets
PRD4563022 · Product
- Active substance
- Ponatinib
- Substance synonyms
- AP-24534, 3-(2-(IMIDAZO(1,2-B)PYRIDAZIN-3-YL)ETHYNYL)-4-METHYL-N-(4-((4-METHYLPIPERAZIN-1- YL)METHYL)-3-(TRIFLUOROMETHYL)PHENYL)BENZAMIDE, Benzamide, 3-(2-imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methyl-1-piperazinyl)methyl]-3-(trifluoromethyl)phenyl]-
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 12.26 g gram(s)
- Max treatment duration
- 32 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EA05 — -
- Marketing authorisation
- EU/1/13/839/001
- MA holder
- INCYTE BIOSCIENCES DISTRIBUTION B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Iclusig 15 mg film-coated tablets
PRD4872103 · Product
- Active substance
- Ponatinib
- Substance synonyms
- AP-24534, 3-(2-(IMIDAZO(1,2-B)PYRIDAZIN-3-YL)ETHYNYL)-4-METHYL-N-(4-((4-METHYLPIPERAZIN-1- YL)METHYL)-3-(TRIFLUOROMETHYL)PHENYL)BENZAMIDE, Benzamide, 3-(2-imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methyl-1-piperazinyl)methyl]-3-(trifluoromethyl)phenyl]-
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 24.51 g gram(s)
- Max treatment duration
- 32 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EA05 — -
- Marketing authorisation
- EU/1/13/839/002
- MA holder
- INCYTE BIOSCIENCES DISTRIBUTION B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 14
SUB05101MIG · Substance
- Active substance
- Vincristine Sulfate
- Pharmaceutical form
- SOLUTION FOR INJECTION OR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 2 mg/m2 milligram(s)/sq. meter
- Max total dose
- 32 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 16 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12149MIG · Substance
- Active substance
- Mercaptopurine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 45250 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 22 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Methylprednisolone Sodium Succinate
SUB14562MIG · Substance
- Active substance
- Methylprednisolone Sodium Succinate
- Pharmaceutical form
- POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 240 mg milligram(s)
- Max treatment duration
- 12 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB13910MIG · Substance
- Active substance
- Folinic Acid
- Pharmaceutical form
- POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 37.5 mg/m2 milligram(s)/sq. meter
- Max total dose
- 787.5 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10020MIG · Substance
- Active substance
- Prednisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 40 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1600 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 40 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02635MIG · Substance
- Active substance
- Idarubicin Hydrochloride
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 12 mg/m2 milligram(s)/sq. meter
- Max total dose
- 84 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dexamethasone Disodium Phosphate
SUB122698 · Substance
- Active substance
- Dexamethasone Disodium Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 10 mg/m2 milligram(s)/sq. meter
- Max total dose
- 300 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 30 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06880MIG · Substance
- Active substance
- Cytarabine
- Pharmaceutical form
- POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS (IV) OR SUBCUTANEOUS (SC)
- Max daily dose
- 4000 mg/m2 milligram(s)/sq. meter
- Max total dose
- 16900 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 16 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06880MIG · Substance
- Active substance
- Cytarabine
- Pharmaceutical form
- POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS (IV) OR SUBCUTANEOUS (SC)
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 12 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02888MIG · Substance
- Active substance
- Lenograstim
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 5 µg/Kg microgram(s)/kilogram
- Max total dose
- 840 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08856MIG · Substance
- Active substance
- Methotrexate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 8580 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 75 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08856MIG · Substance
- Active substance
- Methotrexate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 12.5 mg milligram(s)
- Max total dose
- 150 mg milligram(s)
- Max treatment duration
- 12 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1000 mg/m2 milligram(s)/sq. meter
- Max total dose
- 5200 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 13 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07627MIG · Substance
- Active substance
- Filgrastim
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 5 µg/Kg microgram(s)/kilogram
- Max total dose
- 840 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 24 Week(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
Fondazione Gimema Franco Mandelli Onlus
- Sponsor organisation
- Fondazione Gimema Franco Mandelli Onlus
- Address
- Via Casilina 5
- City
- Rome
- Postcode
- 00182
- Country
- Italy
Scientific contact point
- Organisation
- Fondazione Gimema Franco Mandelli Onlus
- Contact name
- GIMEMA CENTRO DATI
Public contact point
- Organisation
- Fondazione Gimema Franco Mandelli Onlus
- Contact name
- GIMEMA CENTRO DATI
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Laboratorio Ematologia, Azienda Policlinico "Umberto I", Diapartimento Medicina Traslaz. e di Precis ORL-000006908
|
Roma, Italy | Laboratory analysis |
Locations
1 EU/EEA country · 36 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 32 | 36 |
| Rest of world | — | 0 | — |
Investigational sites
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
DIPARTIMENTO DI MEDICINA SPECIALISTICA, DIAGNOSTICA E SPERIMENTALE (DIMES), Via Pietro Albertoni 15, 40138, Bologna
Istituto Europeo di Oncologia - Milano
DIVISIONE DI ONCOEMATOLOGIA, Via Ripamonti,435, Italy, Milano
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
DIPARTIMENTO DI EMATOLOGIA, Via Antonio Cardarelli 9, 80131, Naples
Azienda Ospedaliero-Universitaria Sant Andre
DIPARTIMENTO SCIENZE ONCOLOGICHE, Via Di Grottarossa 1035-1039, 00189, Rome
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Dipartimento di Oncologia ed Ematologia, Piazza Oms 1, 24127, Bergamo
Careggi University Hospital
DIPARTIMENTO DI MEDICINA SPERIMENTALE E CLINICA, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Fondazione Policlinico Universitario Campus Bio-Medico
Divisione Ematologia, Via Alvaro Del Portillo N 200, 00128, Rome
Fondazione IRCCS Policlinico San Matteo
DIPARTIMENTO ONCOLOGIA, Viale Camillo Golgi 19, 27100, Pavia
Azienda Sanitaria Universitaria Friuli Centrale
DIPARTIMENTO DI MEDICINA SPECIALISTICA, Via Pozzuolo 330, 33100, Udine
AORN San Giuseppe Moscati Avellino
Onco-Ematologico, Contrada Amoretta, 83100, Avellino
Azienda Ospedaliera Universitaria Senese
DIPARTIMENTO DI SCIENZE MEDICHE, CHIRURGICHE E NEUROSCIENZE, Strada Delle Scotte 14, 53100, Siena
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
DIPARTIMENTO DI ONCOLOGIA, Viale Strasburgo 233, 90146, Palermo
Azienda Unita Sanitaria Locale Di Piacenza
DIPARTIMENTO ONCOLOGIA - EMATOLOGIA, Via Antonio Anguissola 15, 29121, Piacenza
Hospital Santa Maria Della Misericordia
DIPARTIMENTO DI MEDICINA E CHIRURGIA, Piazzale Giorgio Menghini 1, 06129, Perugia
Azienda Ospedaliera Policlinico Universitario Tor Vergata
DIPARTIMENTO DI MEDICINA, Viale Oxford 81, 00133, Rome
Azienda Ospedaliera Ospedale Niguarda Ca Granda
DIPARTIMENTO DI EMATOLOGIA ED ONCOLOGIA, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Ospedale San Raffaele S.r.l.
AREA ONCOLOGICA, Via Olgettina 60, 20132, Milan
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
DIPARTIMENTO DI CHIRURGIA GENERALE E SPECIALITA' MEDICO CHIRURGICHE, Via Santa Sofia 78, 95123, Catania
Azienda Ospedaliero-Universitaria Maggiore Della Carita
DIMECS E DIPARTIMENTO ONCOLOGICO, Corso Giuseppe Mazzini 18, 28100, Novara
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
DIPARTIMENTO DI DIAGNOSTICA PER IMMAGINI, RADIOTERAPIA ONCOLOGICA ED EMATOLOGIA, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliera Universitaria Integrata Verona
DAI MEDICO GENERALE, Piazzale Aristide Stefani 1, 37126, Verona
University Hospital Of Ferrara
DIPARTIMENTO ONCOLOGIA - EMATOLOGIA, Cona, Via Aldo Moro 8, Ferrara
Azienda Sanitaria Locale Di Salerno
EMATOLOGIA, Via Nizza 146, 84124, Salerno
Azienda Unita Sanitaria Locale Della Romagna
DIPARTIMENTO ONCOEMATOLOGICO, Via Alcide De Gasperi 8, 48121, Ravenna
Ospedale Vito Fazzi Lecce
POLO ONCOLOGICO “GIOVANNI PAOLO II”, Piazza Filippo Muratore 1, 73100, Lecce
Azienda Sanitaria Locale Di Pescara
DIPARTIMENTO ONCOLOGICO-EMATOLOGICO, Via Renato Paolini 47, 65124, Pescara
ULSS3 SERENISSIMA - Ospedale dell'Angelo di Mestre
UO EMATOLOGIA, via Paccagnella 11, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I
DIPARTIMENTO DI MEDICINA TRASLAZIONALE E DI PRECISIONE, Viale Del Policlinico 155, 00161, Rome
Azienda Unita Locale Socio Sanitaria N 8 Berica
DIPARTIMENTO STRUTTURALE ONCOLOGIA CLINICA, Viale Ferdinando Rodolfi 37, 36100, Vicenza
Azienda Ospedaliera Universitaria Federico II Di Napoli
DIPARTIMENTO DI MEDICINA CLINICA E CHIRURGIA, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedale-Universita Padova
DIPARTIMENTO DI EMATOLOGIA ED IMMUNOLOGIA CLINICA, Via Nicolo' Giustiniani 2, 35128, Padova
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
DIPARTIMENTO DI MEDICINA INTERNA, Via Francesco Sforza 28, 20122, Milan
Azienda Unita Sanitaria Locale Della Romagna
DIPARTIMENTO ONCOEMATOLOGICO, Viale Luigi Settembrini 2, 47923, Rimini
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
DIPARTIMENTO DI ONCOLOGIA ED EMATOLOGIA, Corso Bramante 88, 10126, Turin
Azienda Ospedaliera Ordine Mauriziano Di Torino
DIPARTIMENTO DI SCIENZE CLINICHE E BIOLOGICHE, Via Ferdinando Magellano 1, 10128, Turin
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
DIPARTIMENTO DI ONCOLOGIA CLINICA, Piazzale Spedali Civili 1, 25123, Brescia
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2022-10-05 | 2022-10-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-510240-20-00_Redacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_Blank document | 1 |
| Subject information and informed consent form (for publication) | L1_Dear Doctor Letter | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Study_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF translational study_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_PP study_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_PP translational study_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS translational study_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS study_redacted | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC ponatinib IT | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis IT 2023-510240-20-00_Redacted | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-27 | Italy | Acceptable 2024-07-10
|
2024-07-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-06 | Italy | Acceptable | 2025-05-13 |