Study of UCART19 in Pediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukemia (PALL)
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This study aims at evaluating the safety and ability 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
Estimated Primary Completion Date :
Estimated Study Completion Date :
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 v4.03 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:
6 Months 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 therapy
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).
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submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
Where Servier or an affiliate are the Marketing Authorization Holders (MAH).
The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
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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