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Completed

NCT Number: NCT02808442

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

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).

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Key information

Conditions

Refractory B-cell Acute Lymphoblastic Leukemia Burkitt Lymphoma DNA Virus Infections Epstein-Barr Virus Infections Hemic and Lymphatic Diseases Herpesviridae Infections Immune System Diseases Immunoproliferative Disorders Infections Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Relapsed B-cell Acute Lymphoblastic Leukemia Tumor Virus Infections Virus Diseases

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hôpital Robert-Debré, Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UCART19

Biological

Other names: S68587

Primary outcomes

  1. Incidence and Severity of Adverse Events

    Time frame: From inclusion to Month 12

    Adverse events assessed according to NCI-CTCAE v5.0 criteria

Secondary outcomes

  1. Molecular Remission Rate

    Time frame: At Day 28 after the first UCART19 infusion

    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).

Sponsors and collaborators

Lead sponsor

Institut de Recherches Internationales Servier

Other

Collaborators

  • ADIR, a Servier Group company

Registry information

Official study 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

Acronym: PALL

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 21, 2016
Registry last updated
Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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