Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Authorised, recruitment pending
Participants planned
48
Countries
7
Sites
25
relapsed or refractory BCR::ABL1-positive (Philadelphia positive, Ph+) or BCR::ABL1-like (Ph-like) acute lymphoblastic leukemia (ALL)
The primary objective for Part 1 dose escalation is to determine the RP2D and the primary endpoints will be the incidence of DLTs and incidence of severity of AEs and laboratory safety findings. The primary objective for Part 2 dose expansion will be to assess complete remission rates at the end of cycle 1 and the prim…
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-04-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Novartis Pharma AG
External identifiers
- EU CT number
- 2025-522019-40-00
- WHO UTN
- U1111-1332-4863
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Dose response, Safety, Efficacy
The primary objective for Part 1 dose escalation is to determine the RP2D and the primary endpoints will be the incidence of DLTs and incidence of severity of AEs and laboratory safety findings. The primary objective for Part 2 dose expansion will be to assess complete remission rates at the end of cycle 1 and the primary endpoint will be proportion of CR evaluable Ph+ participants achieving CR at the end of cycle 1
Secondary objectives 3
- The secondary objectives of Part 1 of the study are to assess the safety and tolerability of asciminib in combination with the treatment regimen, and to assess the overall response (CR and/or CRi) at end of cycle 1 (debulking induction), cycle 2, and cycle 3 (consolidation) with respect to CR or CRi at the end of cycle 1, 2 and 3, and to assess other efficacy endpoints with respect to MFC and/or NGS MRD negative CR/CRi rate at the end of cycle 1,2 and 3
- To evaluate the safety and tolerability of asciminib in combination with low intensity chemotherapy at the end of cycle 1 (debulking induction) and asciminib plus blinatumomab at the end of cycle 2 and 3 (consolidation)
- To characterize the PK of asciminib in combination with the treatment regimen
Conditions and MedDRA coding
relapsed or refractory BCR::ABL1-positive (Philadelphia positive, Ph+) or BCR::ABL1-like (Ph-like) acute lymphoblastic leukemia (ALL)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | PT | 10003890 | B precursor type acute leukaemia | 100000004864 |
| 28.0 | LLT | 10089798 | B-cell acute lymphoblastic leukemia with BCR-ABL1 | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Male or female participants ≥1 year to ≤30 years of age at screening
- Participants with documented history of either Ph+ ALL or ABL-class Ph-like ALL with ABL1 or ABL2 rearrangements. Genetic testing will be performed locally and eligible alterations confirmed by treating investigators; central confirmation will not be performed as part of the study. (Of note, participants with T315I mutations are eligible for inclusion in Part 1 and Part 2).
- Active B-Cell ALL at screening defined by MFC or IG/TCR PCR of ALL blasts >0.01% in participants with either: a. Primary refractory disease (>0.01% ALL blasts present at the end of consolidation) OR b. Relapsed ALL with evidence of involvement of BM with ALL (MFC or IG/TCR PCR>0.01%) after at least one line of therapy
- Participants with CNS1, CNS2, CNS3a or CNS3b at screening.
- Documented history of CD19 expressing B-cell ALL (in peripheral blood or bone marrow by flow cytometry) a. For participants who received anti-CD19 targeted therapy (e.g CD19 CAR T cells or blinatumomab), CD19 expressing B-cell ALL must be documented after anti-CD19 therapy completion prior to cycle 1 day 1.
Exclusion criteria 5
- Participants with >3 relapses of ALL at screening.
- Extramedullary disease (non-CNS and/ or isolated CNS disease) at screening
- Participants with CNS3c at screening (Clinical signs of CNS leukemia (such as facial nerve palsy, brain/eye involvement or hypothalamic syndrome).
- History of hematopoietic stem cell transplant within the prior 12 weeks
- Presence of active acute or chronic graft-versus-host disease (GVHD). Hematopoietic stem cell transplant recipients receiving any agent to treat or prevent GVHD within 4 weeks are not eligible for this trial.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Part 1 Dose Escalation: Incidence of DLTs occurring during cycle 1 (debulking induction)
- Part 1 Dose Escalation: incidence of severity of AEs and laboratory safety findings
- Part 2 Dose Expansion: Proportion of CR evaluable participants who achieve CR treated at the RP2D at the end of cycle 1 (debulking induction)
Secondary endpoints 8
- • Proportion of participants who had a CR at the end of cycle 2 and cycle 3
- • Proportion of participants who had CR and/or CRi at and by the end of: cycle 1, cycle 2, and cycle 3
- • Next generation sequencing MRD negative rate at and by the end of: end of cycle 1, cycle 2, and cycle 3.
- • MFC MRD negative CR/CRi rate at and by the end of: cycle 1, cycle 2, and cycle 3.
- • Disease Free Survival
- • Overall survival
- Type, frequency, severity of treatment emergent adverse events, changes in laboratory parameters, ECG, and other safety data.
- PK parameters of asciminib at steady state: AUClast, Cmax, Tmax, Ctrough over time (sparse PK sampling)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
SUB05101MIG · Substance
- Active substance
- Vincristine Sulfate
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- IV INFUSION
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Re-labeling step for primary and secondary packaging for products under central sourcing
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling step for primary and secondary packaging for products under central sourcing
Dexamethasone Sodium Phosphate
SUB01615MIG · Substance
- Active substance
- Dexamethasone Sodium Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- IV INFUSION
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling step for primary and secondary packaging for products under central sourcing
SUB35403 · Substance
- Active substance
- Blinatumomab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/09/650
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Re-labeling step for primary and secondary packaging for product under central sourcing
SUB204228 · Substance
- Active substance
- Asciminib Hydrochloride
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/20/2261
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- 40 mg film-coated tablets: Packaged in bottles for clinical trials as compared to the commercial presentation in blisters. SL is 48 months for HDPE bottle (clinical packaging) and SL is 36 months for blister packs (commercial packaging)
PRD10852375 · Product
- Active substance
- Asciminib Hydrochloride
- Substance synonyms
- ABL001-AAA, N-(4-(chlorodifluoromethoxy)phenyl)-6-((3R)-3-hydroxypyrrolidin-1-yl)-5-(1H-pyrazol-3-yl)pyridine-3-carboxamide monohydrochloride
- Pharmaceutical form
- FILM-COATED GRANULES
- Route of administration
- ORAL USE
- Authorisation status
- Not Authorised
- MA holder
- NOVARTIS PHARMA AG
- Paediatric formulation
- Yes
- Orphan designation
- Yes
- Orphan designation number
- EU/3/20/2261
Auxiliary 5
PRD13117054 · Product
- Active substance
- Methotrexate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRATHECAL USE
- Authorisation status
- Not Authorised
- MA holder
- NOVARTIS PHARMA AG
- Paediatric formulation
- No
- Orphan designation
- No
SUB172218 · Substance
- Active substance
- Prednisolone Acetate Ph. Eur.
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRATHECAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Re-labeling step for primary and secondary packaging for products under central sourcing
SUB06880MIG · Substance
- Active substance
- Cytarabine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRATHECAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling step for primary and secondary packaging for centrally sourced products
SUB08065MIG · Substance
- Active substance
- Hydrocortisone
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRATHECAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling step for primary and secondary packaging for centrally sourced products
SUB08856MIG · Substance
- Active substance
- Methotrexate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRATHECAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Re-labeling step for primary and secondary packaging for products sourced centrally
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | Code 12 |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Other, Interactive response technologies (IRT) |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Data management |
| Veeda Clinical Research Limited ORG-100012827
|
Ahmedabad, India | Laboratory analysis |
| Mipharm S.p.A. ORG-100000724
|
Milan, Italy | Code 14 |
| Jumo Health USA Inc. ORG-100044054
|
New Haven, United States | Other |
| Sa Pathology ORG-100044405
|
Adelaide, Australia | Laboratory analysis |
| Adaptive Biotechnologies Corp. ORG-100044428
|
Seattle, United States | Laboratory analysis |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Laboratory analysis |
Locations
7 EU/EEA countries · 25 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Authorised, recruitment pending | 2 | 2 |
| Denmark | Authorised, recruitment pending | 2 | 1 |
| France | Authorised, recruitment pending | 5 | 8 |
| Germany | Authorised, recruitment pending | 3 | 6 |
| Italy | Not authorised | 3 | 3 |
| Netherlands | Authorised, recruitment pending | 2 | 1 |
| Spain | Authorised, recruitment pending | 4 | 4 |
| Rest of world
Singapore, United States, Australia, Taiwan, United Kingdom, Korea, Republic of, Canada, Malaysia, Israel
|
— | 27 | — |
Investigational sites
Fakultni Nemocnice V Motole
6000, Klinika detske hematologie a onkologie, V Uvalu 84/1, Motol, Prague
Institute Of Hematology And Blood Transfusion
6001, U Nemocnice 2094/1, Nove Mesto, Prague
Rigshospitalet
7000: Department of Paediatrics & Adolescent Medicin, Blegdamsvej 9, 2100, Copenhagen Oe
Centre Hospitalier Regional De Marseille
8006: Hématologie oncologie, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Rennes
8000: Hématologie oncologie, 2 Rue Henri Le Guilloux, 35033, Rennes Cedex 9
Hospital Hotel Dieu
8005: Hématologie, 1 Place Alexis Ricordeau, 44000, Nantes
Robert Debre University Hospital
8002: Hématologie, 48 Boulevard Serurier, 75019, Paris
Hopital Saint Louis
8001: Hématologie, 1 Avenue Claude Vellefaux, 75010, Paris
Hospices Civils De Lyon
8003: Hématologie, 1 Place Professeur Joseph Renaut, 69008, Lyon
Centre Hospitalier Universitaire De Bordeaux
8004: Hématologie oncologie, Avenue Du Haut Leveque, 33600, Pessac
Centre Hospitalier Universitaire De Bordeaux
8004: Hématologie oncologie, Place Amelie Raba Leon, 33000, Bordeaux
University Medical Center Hamburg-Eppendorf
9003,Klinik fuer Paediatrische Haematologie und Onkologie, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Erlangen AöR
9000,Kinder- und Jugendklinik Paediatrische Onkologie und Haematologie, Loschgestrasse 15, Innenstadt, Erlangen
Charite Universitaetsmedizin Berlin KöR
9004, Charite – Campus Virchow Klinikum Paediatrische Haematologie und Onkologie, Augustenburger Platz 1, Wedding, Berlin
Universitaetsklinikum Essen AöR
9001, Klinik für Kinderheilkunde III, Hufelandstrasse 55, Holsterhausen, Essen
Goethe University Frankfurt
9002,Klinik fuer Kinder- und Jugendmedizin, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Universitaetsklinikum Koeln AöR
9005, Klinik und Poliklinik für Kinder und Jugendmedizin, Kerpener Strasse 62, Lindenthal, Cologne
Fondazione IRCCS San Gerardo Dei Tintori
1101, U.O.S. Ematologia Pediatrica Clinica Pediatrica, Via Giovanbattista Pergolesi 33, 20900, Monza
Ospedale Pediatrico Bambino Gesu
1100,Dipartimento di Onco-Ematologia, Terapia Cellulare, Terapie Geniche e Trapianto Emopoietico, Piazza Di Sant'onofrio 4, 00165, Rome
IRCCS Istituto Giannina Gaslini
1102, U.O.C. Ematologia, Via Gerolamo Gaslini 5, 16147, Genoa
Prinses Maxima Centrum voor Kinderoncologie B.V.
2100:Trial and data center, Heidelberglaan 25, 3584 CS, Utrecht
Hospital Infantil Universitario Nino Jesus
3103:Oncología, Avenida De Menendez Pelayo 65, 28009, Madrid
Hospital Universitari Vall D Hebron
3100:Oncología, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario La Paz
3101:Oncología, Paseo De La Castellana 261, 28046, Madrid
Hospital Sant Joan De Deu Barcelona
3102:Oncología, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 124 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol - Signature Page_2025-522019-40-00_1_English_Red | 00-EU.01 |
| Protocol (for publication) | D1_Protocol_2025-522019-40-00_1_English_Red | 00-EU.01 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_CZ_NonRed | V01 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_DE_English_NonRed | v01 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_DK_English_NonRed | v1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_ES_Spanish_NonRed | 20Nov2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_FR_NonRed | 00 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_IT_English_NonRed | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_NL_English_NonRed | V01 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_2_FR_French_Red | 00 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_1_DE_German_NonRed | V00 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_1_DK_Danish_Red | V1.0 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_1_ES_Spanish_Red | 1.0 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_1_FR_French_NonRed | V1.1 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_1_IT_Italian_Red | 1.0 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_2_DE_German_NonRed | V00 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_2_ES_Spanish_Red | 1.0 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_2_FR_French_NonRed | V1.1 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_2_IT_Italian_Red | 1.0 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_3_FR_French_Red | 01 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_3_IT_Italian_NonRed | 1.0 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_4_DK_Danish_Red | V1.0 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_4_FR_French_Red | 01 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_4_IT_Italian_NonRed | 1.0 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_5_NL_Dutch_Red | V01 |
| Subject information and informed consent form (for publication) | L1_ICF - Additional Biomarkers_1_DE_German_Red | V00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Additional Biomarkers_2_DE_German_Red | V00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Adolescent Assent_1_CZ_Czech_Red | V00.00.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Adolescent Assent_1_DE_German_NonRed | v00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Adolescent Assent_1_ES_Spanish_NonRed | v00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Adolescent Assent_1_FR_French_Red | 00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Adolescent Assent_1_IT_Italian_NonRed | 00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Adolescent Assent_1_NL_Dutch_Red | V00000002 |
| Subject information and informed consent form (for publication) | L1_ICF - Adolescent Assent_2_DK_Danish_NonRed | V00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Adolescent Becoming Adult_1_FR_French_Red | v00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Child Assent_1_DE_German_NonRed | V00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Child Assent_1_DK_Danish_NonRed | v00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Child Assent_1_ES_Spanish_NonRed | v00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Child Assent_1_FR_French_NonRed | 00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Child Assent_1_IT_Italian_NonRed | 00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Child Assent_2_DK_Danish_NonRed | v00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Child Assent_3_DK_Danish_NonRed | v00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_CZ_Czech_NonRed | V00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_DE_German_NonRed | v00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_ES_Spanish_NonRed | v00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_IT_Italian_NonRed | 00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_NL_Dutch_NonRed | V00000000 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_DE_German_NonRed | V00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_FR_French_NonRed | 00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Home Nursing Service_1_FR_French_NonRed | 00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Home Nursing Service_2_FR_French_NonRed | 00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_CZ_Czech_Red | V00.00.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_DE_German_Red | V00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_DK_Danish_Red | v00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_ES_Spanish_Red | v00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_FR_French_Red | v00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_IT_Italian_Red | 00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_NL_Dutch_Red | V00000002 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_CZ_Czech_Red | V00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_DK_Danish_NonRed | v1 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_ES_Spanish_Red | v00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_IT_Italian_Red | 00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_2_CZ_Czech_Red | V00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_2_ES_Spanish_Red | v00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_2_IT_Italian_Red | 00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_3_CZ_Czech_Red | V00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_4_CZ_Czech_Red | V00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_5_CZ_Czech_NonRed | V1.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_6_CZ_Czech_NonRed | V1.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Parent Legal Guardian_1_CZ_Czech_Red | V00.00.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Parent Legal Guardian_1_DE_German_Red | V00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Parent Legal Guardian_1_DK_Danish_Red | v00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Parent Legal Guardian_1_ES_Spanish_Red | v00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Parent Legal Guardian_1_FR_French_Red | 00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Parent Legal Guardian_1_IT_Italian_Red | 00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Parent Legal Guardian_1_NL_Dutch_Red | V00000002 |
| Subject information and informed consent form (for publication) | L1_ICF - Pre-Adolescent Assent_1_CZ_Czech_NonRed | V00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Pregnancy Follow up Parent Legal Guardian_1_FR_French_NonRed | 00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Pregnancy Follow up Parent Legal Guardian_1_NL_Dutch_NonRed | V00000000 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_1_CZ_Czech_NonRed | V00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_2_CZ_Czech_NonRed | V00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF Procedure_1_ES_Spanish_NonRed | v1.0 |
| Subject information and informed consent form (for publication) | L1_List of submitted documents Part II_1_CZ_NonRed | V2.0 |
| Subject information and informed consent form (for publication) | L1_Patient Card_1_CZ_Czech_NonRed | 24Jan2024 |
| Subject information and informed consent form (for publication) | L1_Patient Card_1_IT_Italian_NonRed | 1.0 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_1_CZ_Czech_NonRed | V1.0 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_1_DE_German_Red | V1.0 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_2_CZ_Czech_NonRed | V1.0 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_2_DE_German_Red | V1.0 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_3_CZ_Czech_NonRed | V1.0 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_3_DE_German_NonRed | V1.0 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_4_CZ_Czech_NonRed | V1.0 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_4_DE_German_NonRed | V1.0 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_DE_English_NonRed | V1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference SmPC_1_Dexamethasone_English_NonRed | 01Feb2022 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference SmPC_1_Vincristine_English_NonRed | 06Dec2024 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_1_Blinatumomab_English_NonRed | 09Mar2023 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_1_Demezon_SUN-FARM_T_English_NonRed | 18Dec2018 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_1_Dexa inject JENAPHARM_mibe_English_NonRed | 01Apr2023 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_1_Dexa inject JENAPHARM_mibe_German_NonRed | 01Apr2023 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_1_DexaGalen_GALENpharma_English_NonRed | 01Dec2021 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_1_DexaGalen_GALENpharma_German_NonRed | 01Dec2021 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_1_Dexamethason GALEN_GALENpharma_T_English_NonRed | 01Nov2020 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_1_Dexamethason GALEN_GALENpharma_T_German_NonRed | 01Nov2020 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_1_Dexamethason JENAPHARM_mibe_T_English_NonRed | 01Nov2024 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_1_Dexamethason JENAPHARM_mibe_T_German_NonRed | 01Nov2024 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_1_Dexamethason_ratiopharm_T_English_NonRed | 7 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_1_Dexamethason_ratiopharm_T_German_NonRed | 7 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_1_Dexamethasone_Zentiva_NO_T_English_NonRed | 05Jul2023 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_1_Dexamethasone_Zentiva_PL_T_English_NonRed | 10Nov2025 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_1_Fortecortin_Merck_English_NonRed | 01Jul2023 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_1_Fortecortin_Merck_German_NonRed | 01Jul2023 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_1_Pabi_Dexamethason_Adamed_T_English_NonRed | 02Feb2015 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_1_VINCRISIN_Teva_English_NonRed | 01Aug2024 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_1_Vincristine_SINDOVIN_Teva_English_NonRed | 01Sep2019 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_1_Vincristine_Teva_English_NonRed | 01Sep2024 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2025-522019-40-00_1_Czech_NonRed | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2025-522019-40-00_1_Dutch_NonRed | 00 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2025-522019-40-00_1_English_NonRed | 00 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2025-522019-40-00_1_French_NonRed | 00 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2025-522019-40-00_1_Italian_NonRed | 00 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2025-522019-40-00_1_Spanish_NonRed | 00 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Technical Language_2025-522019-40-00_1_Czech_Red | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Technical Language_2025-522019-40-00_1_French_Red | 00 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-18 | Denmark | Acceptable 2026-04-27
|
2026-04-27 |