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Study of UCART19 in Pediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukemia

NCT02808442

Description:

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).

Related Conditions:
  • B-Cell Acute Lymphoblastic Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT02808442

Trial Eligibility

Document

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

DrugSynonymsArms
UCART19S68587UCART19

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

NameTypeDescriptionInterventions
UCART19Experimental
  • UCART19

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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