Clinical Trials /

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

NCT02808442

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).

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

Completed

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 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).

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 within 4 weeks before UCART19 infusion

          -  Patients with autoimmune disease requiring systemic immunosuppression therapy that
             cannot be stopped

          -  History of CRS grade 4 related to previous CAR T cell therapy

          -  Contraindication to Alemtuzumab administration
Maximum Eligible Age:17 Years
Minimum Eligible Age:N/A
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 v5.0 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:Completed
Lead Sponsor:Institut de Recherches Internationales Servier

Last Updated

December 24, 2020