A Study to Evaluate the Long-term Safety of Patients With Advanced Lymphoid Leukemia Who Have Been Previously Administered With UCART19
NCT ID: NCT02735083
Last Updated: 2025-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE1
28 participants
INTERVENTIONAL
2021-03-10
2028-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dose Escalation Study of UCART19 in Adult Patients With Relapsed / Refractory B-cell Acute Lymphoblastic Leukaemia
NCT02746952
An Extension Study to Evaluate the Safety and Efficacy of an Anti-CD19 CAR-T Product in Patients with B-cell Lymphoproliferative Disorders
NCT06721598
CAR T-cell Long-Term Follow-Up, Quality of Life and Adverse Reactions
NCT07048535
A Study to Evaluate the Tolerability, Safety, and Efficacy of an Anti-CD19 CAR-T Product in Patients With B-cell Lymphoproliferative Disorders
NCT06705530
Treatment of Relapsed and/or Chemotherapy Refractory B-cell Malignancy by CART19
NCT01864889
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ADIR, a Servier Group company
INDUSTRY
Institut de Recherches Internationales Servier
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Reuben Benjamin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
King's College Hospital NHS Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's Hospital Los Angeles
Los Angeles, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Moffit Cancer Center
Tampa, Florida, United States
Massachussetts General Hospital
Charlestown, Massachusetts, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
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
Countries
Review the countries where the study has at least one active or historical site.
Study Documents
Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.
Document Type: Individual Participant Data Set
View DocumentDocument Type: Study Protocol
View DocumentDocument Type: Statistical Analysis Plan
View DocumentDocument Type: Informed Consent Form
View DocumentDocument Type: Clinical Study Report
View DocumentDocument Type: Study-level clinical trial data
View DocumentRelated Links
Access external resources that provide additional context or updates about the study.
Find Results on Servier Clinical Trial Data
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-000297-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CL1-68587-003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.