Dose Escalation Study of UCART19 in Adult Patients With Relapsed / Refractory B-cell Acute Lymphoblastic Leukaemia (CALM)
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ClinicalTrials.gov Identifier: NCT02746952
Recruitment Status :
First Posted : April 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 )
The study is in two parts: a dose escalation then a safety dose expansion. The purpose of the dose escalation part is to evaluate the safety and tolerability of ascending doses of UCART19 (dose-escalation part) given as a single infusion in patients with relapsed / refractory (R/R) B-cell acute lymphoblastic leukaemia (B-ALL), to determine the maximum tolerated dose (MTD), the recommended dose and the lymphodepletion regimen. The purpose of the safety dose expansion is to assess the safety and tolerability of the RD for UCART19.
Phase I, Open Label, Dose-escalation Study Followed by a Safety Expansion Part to Evaluate the Safety, Expansion and Persistence of a Single Dose of UCART19 (Allogeneic Engineered T-cells Expressing Anti-CD19 Chimeric Antigen Receptor), Administered Intravenously in Patients With Relapsed or Refractory CD19 Positive B-cell Acute Lymphoblastic Leukaemia (B-ALL)
Actual Study Start Date :
August 1, 2016
Actual Primary Completion Date :
July 28, 2020
Actual Study Completion Date :
July 28, 2020
Resource links provided by the National Library of Medicine
Dose escalation part: Dose Limiting Toxicities (DLTs) occurence. Dose expansion part: AE throughout the study. [ Time Frame: Dose Escalation: Up to day 28 post first UCART19 infusion. Dose Expansion: From inclusion to Month 12 ]
Secondary Outcome Measures :
Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability [ Time Frame: From inclusion to Month 12 ]
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Objective Remission Rate [ Time Frame: At Day 28, Day 84, Month 4, Month 6, Month 9 and Month12 ]
Proportion of patients in whom a response among molecular complete remission (mCR), morphologic complete remission (CR) and complete remission with incomplete blood count recovery (CRi)
Duration of remission [ Time Frame: From the time that response criteria are first met until the date of progression or death (whatever the reason of death), whichever occurs first, assessed up to Month 12 ]
Time to remission [ Time Frame: From the date of UCART19 administration until the date that response criteria are met, assessed up to Month 12 ]
Progression Free Survival (PFS) [ Time Frame: From the date of UCART19 administration until the date of progression or the date of death (whatever the reason of death), whichever occur first, assessed up to Month 12 ]
Overall Survival (OS) [ Time Frame: From the date of UCART19 administration to the date of death from any cause, assessed up to Month 12 ]
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Ages Eligible for Study:
16 Years to 69 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male or female participant
Age ≥ 16 years
Patient with relapsed or refractory CD19 positive B-acute lymphoblastic leukaemia (B-ALL) who have exhausted alternative treatment options
Estimated life expectancy ≥ 12 weeks (according to investigator's judgement)
Eastern Cooperative Oncology Group (ECOG) performance status < 2
Previous treatment with gene or gene-modified cell therapy medicine products or adoptive T cell therapy
Use of previous anti-leukemic therapy (including approved therapies and other investigational products) within 5 half-lives prior to UCART19 administration
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.
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In addition, access can be requested for all interventional clinical studies in patients:
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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:
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immune System Diseases