Description:
This study aims to evaluate the safety and feasibility of UCART19 to induce molecular
remission in pediatric patients with relapsed or refractory CD19-positive B-cell acute
lymphoblastic leukemia (B-ALL).
Title
- Brief Title: Study of UCART19 in Pediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukemia
- Official Title: A Phase 1, Open Label, Non-comparative Study to Evaluate the Safety and the Ability of UCART19 to Induce Molecular Remission in Paediatric Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukaemia
Clinical Trial IDs
- ORG STUDY ID:
UCART19_02 (CL1-68587-001)
- SECONDARY ID:
2015-004293-15
- NCT ID:
NCT02808442
Conditions
- Refractory B-cell Acute Lymphoblastic Leukemia
- Relapsed B-cell Acute Lymphoblastic Leukemia
Interventions
Drug | Synonyms | Arms |
---|
UCART19 | S68587 | UCART19 |
Purpose
This study aims at evaluating the safety and feasibility of UCART19 to induce molecular
remission in pediatric patients with relapsed or refractory CD19-positive B-cell acute
lymphoblastic leukemia (B-ALL).
Trial Arms
Name | Type | Description | Interventions |
---|
UCART19 | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
- Patient with relapsed or refractory CD19-positive B-acute lymphoblastic leukaemia
(B-ALL) who have exhausted alternative treatment options.
- Estimated life expectancy ≥ 12 weeks
- Lansky (age < 16 years at the time of assent/consent) or Karnofsky (age ≥ 16 years at
time of assent/consent) performance status ≥ 50
Exclusion Criteria:
- Burkitt leukemia
- CD19-negative B-cell leukemia
- Active Central Nervous System (CNS) leukemia
- Active acute or chronic Graft-versus-Host Disease (GvHD) requiring systemic use
therapy
Maximum Eligible Age: | 17 Years |
Minimum Eligible Age: | 6 Months |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence and Severity of Adverse Events |
Time Frame: | From inclusion to Month 12 |
Safety Issue: | |
Description: | Adverse events assessed according to NCI-CTCAE v4.03 criteria |
Secondary Outcome Measures
Measure: | Molecular Remission Rate |
Time Frame: | At Day 28 after the first UCART19 infusion |
Safety Issue: | |
Description: | Proportion of patients in whom a molecular Complete Remission (CR) or a Complete Remission with incomplete blood recovery (CRi) is observed (i.e. a CR or CRi combined to a Minimal residual disease <10-4). |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Institut de Recherches Internationales Servier |
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