Study of UCART19 in Pediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukemia (PALL)
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ClinicalTrials.gov Identifier: NCT02808442
Recruitment Status :
First Posted : June 21, 2016
Last Update Posted : December 24, 2020
Institut de Recherches Internationales Servier
ADIR, a Servier Group company
Information provided by (Responsible Party):
Servier ( Institut de Recherches Internationales Servier )
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).
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
Actual Study Start Date :
June 3, 2016
Actual Primary Completion Date :
September 17, 2020
Actual Study Completion Date :
November 4, 2020
Resource links provided by the National Library of Medicine
Incidence and Severity of Adverse Events [ Time Frame: From inclusion to Month 12 ]
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Secondary Outcome Measures :
Molecular Remission Rate [ Time Frame: At Day 28 after the first UCART19 infusion ]
Proportion of patients in whom a molecular Complete Remission (CR) or a Complete Remission with incomplete blood recovery (CRi) is observed (i.e. a CR or CRi combined to a Minimal residual disease <10-4).
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Ages Eligible for Study:
up to 17 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
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.
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
After Marketing Authorisation in EEA or US if the study is used for the approval.
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.
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Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Product Manufactured in and Exported from the U.S.:
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immune System Diseases