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

NCT02735083 · tracked via the Priya Life Science Spain tracker

Sponsor

Institut de Recherches Internationales Servier

Phase

Phase 1

Started

2021-03-10

Last updated

2025-04-11

Condition(s) studied

Advanced Lymphoid Leukemia

Investigational drug(s) / intervention(s)

UCART19 follow-up

UCART19 follow-up: UCART19 will not be administered during the study period. Patients who will be rolled-over from the parent study to this long term follow-up study, have previously received UCART19. The roll-over occurs at the end of the parent study, or at any time after UCART19 administration, in case of premature discontinuation from the parent study.

Study summary

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

Eligibility

Sex

ALL

Min age

—

Max age

—

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

Primary outcome measure(s)

Long-term safety of UCART19 with or without alemtuzumab — Up to 15 Year
* Number, duration, outcome of all adverse events (AE) within 12 months post last UCART19 infusion * Number, duration, outcome of adverse events of special interest (AESI) up to the end of the study * Proportion of patients with adverse events leading to death up to the end of the study * For paediatric patients: assesment of the potential impact on growth curve and puberty

Trial sites (16)

Facility	City	Region
Children's Hospital Los Angeles	Los Angeles	California
Colorado Blood Cancer Institute	Denver	Colorado
Moffit Cancer Center	Tampa	Florida
Massachussetts General Hospital	Charlestown	Massachusetts
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
University of Texas Southwestern Medical Center	Dallas	Texas
University of Texas MD Anderson Cancer Center	Houston	Texas
Hôpital Saint-Louis	Paris	France
Hôpital Robert-Debré	Paris	France
Hôpital Saint-Antoine	Paris	France
Kyushyu University Hospital	Fukuoka	Japan
Hokkaido University Hospital	Sapporo	Japan
Hospital San Juan De Dios	Barcelona	Spain
King's College Hospital NHS Foundation Trust	London	United Kingdom
UCL Great Ormond Hospital	London	United Kingdom
The Christie NHS Foundation Trust	Manchester	United Kingdom

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02735083 on ClinicalTrials.gov ↗ ← All trials in Spain