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

Phase 1

Active, not recruiting

• Conditions: Advanced Lymphoid Leukemia
• Interventions: Biological: UCART19 follow-up

• Registration Number: NCT02735083
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-14
• Study First Submitted QC: 2016-04-06
• Study First Posted: 2016-04-12
• Study Start: 2021-03-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11
• Primary Completion: 2028-09
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
UCART19 follow-up	UCART19 follow-up	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Proportion of patients who underwent allogeneic HSCT (Hematopoietic Stem Cell Transplantation) for patients treated with UCART19	Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15
Proportion of patients with detectable UCART19 levels in blood	Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing (If no more UCART19 detectable at the Month 12 visit), then every 6 months up to Year 3, then yearly up to Year 15 or the first evidence of no more detectable UCART19 (if earlier)
Assessment of long-term anti tumor activity of UCART19	Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing then every 6 months up to Year 3, then yearly up to Year 15
Time to transplant for patients treated with UCART19	Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15
Assessment of overall survival	Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15
Proportion of patients with detectable UCART19 levels in bone marrow	Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15

Trial Locations

Locations (16)

Colorado Blood Cancer Institute; 🇺🇸 Denver, Colorado, United States

Hokkaido University Hospital; 🇯🇵 Sapporo, Japan

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

Massachussetts General Hospital; 🇺🇸 Charlestown, Massachusetts, United States

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Moffit Cancer Center; 🇺🇸 Tampa, Florida, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Hôpital Robert-Debré; 🇫🇷 Paris, France

Hôpital Saint-Antoine; 🇫🇷 PARIS Cedex 12, France

Hôpital Saint-Louis; 🇫🇷 Paris, France

Kyushyu University Hospital; 🇯🇵 Fukuoka, Japan

UCL Great Ormond Hospital; 🇬🇧 London, United Kingdom

Hospital San Juan De Dios; 🇪🇸 Barcelona, Spain

King's College Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom

The Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom