A Study to Evaluate the Long-term Safety of Patients With Advanced Lymphoid Leukemia Who Have Been Previously Administered With UCART19
Long-term Follow-up Study of Patients Who Have Previously Been Exposed to UCART19 (Allogeneic Engineered T-cells Expressing a Lentiviral-based Anti-CD19 Chimeric Antigen Receptor)
2 other identifiers
interventional
28
5 countries
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2021
Longer than P75 for phase_1
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2016
CompletedFirst Posted
Study publicly available on registry
April 12, 2016
CompletedStudy Start
First participant enrolled
March 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
April 11, 2025
April 1, 2025
7.5 years
March 14, 2016
April 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Long-term safety of UCART19 with or without alemtuzumab
* 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
Up to 15 Year
Secondary Outcomes (6)
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
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
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 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)
- +1 more secondary outcomes
Study Arms (1)
UCART19 follow-up
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80219, United States
Moffit Cancer Center
Tampa, Florida, 33612, United States
Massachussetts General Hospital
Charlestown, Massachusetts, 02129, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75235, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Hôpital Saint-Louis
Paris, 75010, France
Hôpital Robert-Debré
Paris, 75019, France
Hôpital Saint-Antoine
Paris, 75571, France
Kyushyu University Hospital
Fukuoka, 812-8582, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
Hospital San Juan De Dios
Barcelona, 08950, Spain
King's College Hospital NHS Foundation Trust
London, SE5 9RS, United Kingdom
UCL Great Ormond Hospital
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Reuben Benjamin, MD, PhD
King's College Hospital NHS Trust
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2016
First Posted
April 12, 2016
Study Start
March 10, 2021
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
April 11, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After Marketing Authorisation in EEA or US if the study is used for the approval.
- Access Criteria
- Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.