A Study to Evaluate the Long-term Safety of Patients With Advanced Lymphoid Leukemia Who Have Been Previously Administered With UCART19

Servier

Status and phase: Active, not recruiting; Phase 1

Conditions: Advanced Lymphoid Leukemia

Treatments: Biological: UCART19 follow-up

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02735083

2016-000297-38 (EudraCT Number)

CL1-68587-003

Details and patient eligibility

About

The purpose of this study is to evaluate the long-term safety and efficacy of UCART19 administration to patients with advanced lymphoid leukemia.

Enrollment: 28 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent obtained prior any study-specific procedure (patient or parent(s) or legal representative)
• Patient dosed with UCART19 who completed or discontinued early from a sponsored or from any investigator-initiated study that tested UCART19, or patients who were administered UCART19 under a special access scheme (compassionate use);
• Female patients of childbearing potential and male patients with partners of childbearing potential must continue to use an effective method of birth control as well as their partners for a 12-month duration after the last UCART19 administration.

Exclusion criteria

• No exclusion criteria for this study

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

UCART19 follow-up

Experimental group

Treatment:

Biological: UCART19 follow-up