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

Completed · Phase 1

Conditions studied: Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed B-cell Acute Lymphoblastic Leukemia

In brief

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).

Key facts

Study ID

NCT02808442

Run by

Institut de Recherches Internationales Servier

People needed

13

Starts

2016-06-03

Expected to finish

2020-11-04

Last updated by the study team

2021-10-08

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Hôpital Robert-Debré — Paris, France
• Hospital San Juan De Dios — Barcelona, Spain
• UCL Great Ormond Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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