Clinical trial · Interventional
International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010
International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010 A Randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group
NCT01802814CI-TRIAL-00073856completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main goal of this study is to improve the outcome of children and adolescents with standard risk (SR) first relapsed acute lymphoblastic leukemia. Furthermore, goal is to set up a large international study group platform allowing for optimization of standard treatment strategies and integration of new agents.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia (ALL) | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SR-A + Epratuzumab | Drug | — | UNRESOLVED |
| SR-B + Epratuzumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- SR-A
- description
- Patients randomized to the SR-A Arm receive induction, consolidation and maintenance therapy according to a modified protocol ALL-REZ BFM 2002 with Protocol II-IDA as 1st consolidation element. In this arm patients are randomized not to receive epratuzumab.This randomization has been stopped pre-term on 1.2.2019 since the investigational product is not provided anymore by the manufacturer.
- type
- ACTIVE_COMPARATOR
- label
- SR-A + Epratuzumab
- description
- Patients randomized to the SR-A Arm receive induction, consolidation and maintenance therapy according to a modified protocol ALL-REZ BFM 2002 with Protocol II-IDA as 1st consolidation element. In this arm patients are randomized to receive epratuzumab. This randomization has been stopped pre-term on 1.2.2019 since the investigational product is not provided anymore by the manufacturer.
- interventionNames
- Drug: SR-A + Epratuzumab
- type
- NO_INTERVENTION
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Day
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL * Children less than 18 years of age at inclusion * Meeting SR criteria: late isolated or late/early combined B-cell precursor (BCP) bone marrow (BM) relapse, any late/early isolated extramedullary relapse * Patient enrolled in a participating centre * Written informed consent * Start of treatment falling into the study period * No participation in other clinical trials 30 days prior to study enrolment that interfere with this protocol, except trials for primary ALL Inclusion criteria specific for the epratuzumab randomization * Precursor B-cell immunophenotype. A specific CD22 expression level is not required * M1 or M2 status of the bone marrow after induction Exclusion Criteria: * BCR-ABL / t(9;22) positive ALL * Pregnancy or positive pregnancy test (urine sample positive for β-HCG \> 10 U/l) * Sexually active adolescents not willing to use highly effective contraceptive method (pearl index \<1) until 2 years after end of antileukemic therapy * Breast feeding * Relapse post allogeneic stem-cell transplantation * The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian * No consent is given for saving and propagation of pseudonymized medical data for study reasons * Severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders) * Karnovsky / Lansky score \< 50% * Subjects unwilling or unable to comply with the study procedures * Subjects who are legally detained in an official institute
References
Publications (1)
- DERIVEDSidhu J, Gogoi MP, Krishnan S, Saha V. Relapsed Acute Lymphoblastic Leukemia. Indian J Pediatr. 2024 Feb;91(2):158-167. doi: 10.1007/s12098-023-04635-4. Epub 2023 Jun 21. PMID 37341952