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van CCT (UK)


International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010


- candidate number19253
- NTR NumberNTR4720
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-aug-2014
- Secondary IDs 
- Public TitleInternational Study for Treatment of Standard Risk Childhood Relapsed ALL 2010
- Scientific TitleInternational Study for Treatment of Standard Risk Childhood Relapsed ALL 2010
- ACRONYMIntReALL SR 2010
- hypothesisPrimary objectives:
- Overall: Improvement of event-free survival (EFS) probabilities in childhood relapsed ALL
- Randomization 1: EFS of Arm A (ALL-REZ BFM 2002) versus B (ALLR3) in SR patients
- Randomization 2: Influence of epratuzumab on EFS in consolidation of SR patients

Secondary objectives:
- OS of Arm A (ALL-REZ BFM 2002) versus B (ALLR3) in SR patients
- Influence of epratuzumab on OS in consolidation of SR patients
- Rate of second complete remission (CR2) of Arm A versus Arm B
- Rate of SCT performed in Arm A versus Arm B
- Toxicity of randomized SR arms A versus B
- Toxicity of consolidation with versus without epratuzumab
- Improvement of MRD reduction during consolidation with versus without epratuzumab
- Rate of MRD negativity prior to SCT with Arm A vs. Arm B
- Rate of MRD negativity prior to SCT after consolidation with versus without epratuzumab
- Pharmacokinetic of epratuzumab in context with arm A and arm B
- Healt Condition(s) or Problem(s) studiedAcute Lymfatic Leukemia (ALL), Relapse
- 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 BCP 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2014
- planned closingdate1-okt-2018
- Target number of participants65
- Interventions- SR arm A (ALL-REZ BFM 2002 arm Prot II-IDA): Induction: SIA (F1, F2); Post induction: SCA1 and SCA2 ± epratuzumab (8x360mg/m˛/ 1 hrs IV weekly, week 5-12), 5 courses SCA3-7 (R1/2/1/2/1), 24 months maintenance (6MP, MTX) with 6 x TIT / 4 weeks. Cranial irradiation 18Gy for CNS relapse.

- SR arm B (UK-R3, arm mitoxantrone): Induction: SIB (phase I); Post induction: SCB1 and SCB2 (R3-consolidation and intensification) ± epratuzumab (8x360mg/m˛/ 1hrs IV weekly, week 6-13), 2 courses SCB3-4 (R3-interim maintenance 1 and 2), 24 months maintenance (6MP, MTX, 4-weekly VCR/DEX/IT reinduction pulses). Cranial irradiation 18 for CNS disease.

- SCT indications: Any donor Arm A with MRD >10-3 after SIA, arm B with > 10-4 after SIB. Matched donor any early combined, isolated extramedullary relapse or patients without MRD results. SCT is scheduled at week 16
- Primary outcomePrimary parameters:
- Overall: Improvement of event-free survival (EFS) probabilities in childhood relapsed ALL
- Randomization 1: EFS of Arm A (ALL-REZ BFM 2002) versus B (ALLR3) in SR patients
- Randomization 2: Influence of epratuzumab on EFS in consolidation of SR patients
- Secondary outcomeSecondary parameters:
- OS of Arm A (ALL-REZ BFM 2002) versus B (ALLR3) in SR patients
- Influence of epratuzumab on OS in consolidation of SR patients
- Rate of second complete remission (CR2) of Arm A versus Arm B
- Rate of SCT performed in Arm A versus Arm B
- Toxicity of randomized SR arms A versus B
- Toxicity of consolidation with versus without epratuzumab
- Improvement of MRD reduction during consolidation with versus without epratuzumab
- Rate of MRD negativity prior to SCT with Arm A vs. Arm B
- Rate of MRD negativity prior to SCT after consolidation with versus without epratuzumab
- Pharmacokinetic of epratuzumab in context with arm A and arm B
- TimepointsPlanned start: October 1, 2014
4 years recruitment until October 1, 2018
3 years of follow up after inclusion of last patient until October 1, 2021
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. J.G. Ridder-Sluiter, de
- CONTACT for SCIENTIFIC QUERIESProf. dr. N. Hoogerbrugge
- Sponsor/Initiator Dutch Childhood Oncology Group (DCOG), Charité - University Hospital of Berlin
- Funding
(Source(s) of Monetary or Material Support)
EU FP 7 , European Union
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD5-aug-2014 - 31-aug-2014


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