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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-03

Study Completion Date

2020-11-04

Brief Summary

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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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Detailed Description

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Conditions

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Refractory B-cell Acute Lymphoblastic Leukemia Relapsed B-cell Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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UCART19

Group Type EXPERIMENTAL

UCART19

Intervention Type BIOLOGICAL

Interventions

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UCART19

Intervention Type BIOLOGICAL

Other Intervention Names

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S68587

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No