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 :
Completed
First Posted : April 21, 2016
Last Update Posted : October 1, 2021
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Sponsor:
Institut de Recherches Internationales Servier
Collaborator:
ADIR, a Servier Group company
Information provided by (Responsible Party):
Servier ( Institut de Recherches Internationales Servier )
Tracking Information | |||||||||||||||||||
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First Submitted Date ICMJE | March 7, 2016 | ||||||||||||||||||
First Posted Date ICMJE | April 21, 2016 | ||||||||||||||||||
Last Update Posted Date | October 1, 2021 | ||||||||||||||||||
Actual Study Start Date ICMJE | August 1, 2016 | ||||||||||||||||||
Actual Primary Completion Date | July 28, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Current Primary Outcome Measures ICMJE |
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 ] | ||||||||||||||||||
Original Primary Outcome Measures ICMJE |
Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability [ Time Frame: through study completion, an average of 12 weeks ] Adverse events assessed according to NCI-CTCAE v4.0 criteria
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Change History | |||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Descriptive Information | |||||||||||||||||||
Brief Title ICMJE | Dose Escalation Study of UCART19 in Adult Patients With Relapsed / Refractory B-cell Acute Lymphoblastic Leukaemia | ||||||||||||||||||
Official Title ICMJE | 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) | ||||||||||||||||||
Brief Summary | 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. | ||||||||||||||||||
Detailed Description | Not Provided | ||||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||||
Study Phase ICMJE | Phase 1 | ||||||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | B-cell Acute Lymphoblastic Leukemia | ||||||||||||||||||
Intervention ICMJE | Biological: UCART19
Other Name: S68587
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Study Arms ICMJE | Experimental: UCART19
Intervention: Biological: UCART19
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||||
Actual Enrollment ICMJE |
25 | ||||||||||||||||||
Original Estimated Enrollment ICMJE |
12 | ||||||||||||||||||
Actual Study Completion Date ICMJE | July 28, 2020 | ||||||||||||||||||
Actual Primary Completion Date | July 28, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 16 Years to 69 Years (Child, Adult, Older Adult) | ||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||
Listed Location Countries ICMJE | France, Japan, United Kingdom, United States | ||||||||||||||||||
Removed Location Countries | |||||||||||||||||||
Administrative Information | |||||||||||||||||||
NCT Number ICMJE | NCT02746952 | ||||||||||||||||||
Other Study ID Numbers ICMJE | CL1-68587-002 2016-000296-24 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Servier ( Institut de Recherches Internationales Servier ) | ||||||||||||||||||
Original Responsible Party | Servier | ||||||||||||||||||
Current Study Sponsor ICMJE | Institut de Recherches Internationales Servier | ||||||||||||||||||
Original Study Sponsor ICMJE | Servier | ||||||||||||||||||
Collaborators ICMJE | ADIR, a Servier Group company | ||||||||||||||||||
Investigators ICMJE |
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PRS Account | Servier | ||||||||||||||||||
Verification Date | September 2021 | ||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |