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

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.

Recruitment & Eligibility

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

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

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