Study of UCART19 in Pediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukemia
PALL
A Phase 1, Open Label, Non-comparative Study to Evaluate the Safety and the Ability of UCART19 to Induce Molecular Remission in Paediatric Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukaemia
2 other identifiers
interventional
13
4 countries
6
Brief Summary
This study aims to evaluate the safety and feasibility of UCART19 to induce molecular remission in pediatric patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2016
Longer than P75 for phase_1
6 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
Study Start
First participant enrolled
June 3, 2016
CompletedFirst Submitted
Initial submission to the registry
June 16, 2016
CompletedFirst Posted
Study publicly available on registry
June 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 4, 2020
CompletedOctober 8, 2021
September 1, 2021
4.3 years
June 16, 2016
September 30, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence and Severity of Adverse Events
Adverse events assessed according to NCI-CTCAE v5.0 criteria
From inclusion to Month 12
Secondary Outcomes (1)
Molecular Remission Rate
At Day 28 after the first UCART19 infusion
Study Arms (1)
UCART19
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patient with relapsed or refractory CD19-positive B-acute lymphoblastic leukaemia (B-ALL) who have exhausted alternative treatment options.
- Estimated life expectancy ≥ 12 weeks
- Lansky (age \< 16 years at the time of assent/consent) or Karnofsky (age ≥ 16 years at time of assent/consent) performance status ≥ 50
You may not qualify if:
- Burkitt leukemia
- CD19-negative B-cell leukemia
- Active Central Nervous System (CNS) leukemia
- Active acute or chronic Graft-versus-Host Disease (GvHD) requiring systemic use therapy within 4 weeks before UCART19 infusion
- Patients with autoimmune disease requiring systemic immunosuppression therapy that cannot be stopped
- History of CRS grade 4 related to previous CAR T cell therapy
- Contraindication to Alemtuzumab administration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Hôpital Robert-Debré
Paris, 75019, France
Hospital San Juan De Dios
Barcelona, 08950, Spain
UCL Great Ormond Hospital
London, United Kingdom
Related Publications (1)
Benjamin R, Graham C, Yallop D, Jozwik A, Mirci-Danicar OC, Lucchini G, Pinner D, Jain N, Kantarjian H, Boissel N, Maus MV, Frigault MJ, Baruchel A, Mohty M, Gianella-Borradori A, Binlich F, Balandraud S, Vitry F, Thomas E, Philippe A, Fouliard S, Dupouy S, Marchiq I, Almena-Carrasco M, Ferry N, Arnould S, Konto C, Veys P, Qasim W; UCART19 Group. Genome-edited, donor-derived allogeneic anti-CD19 chimeric antigen receptor T cells in paediatric and adult B-cell acute lymphoblastic leukaemia: results of two phase 1 studies. Lancet. 2020 Dec 12;396(10266):1885-1894. doi: 10.1016/S0140-6736(20)32334-5.
PMID: 33308471RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2016
First Posted
June 21, 2016
Study Start
June 3, 2016
Primary Completion
September 17, 2020
Study Completion
November 4, 2020
Last Updated
October 8, 2021
Record last verified: 2021-09
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.