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NCT02999633 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia
A Phase 2 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT02999633: Clinical Trial Phase 2 study, sponsored by Sanofi.
NCT02999633 is a Phase 2 study that was terminated before completion, run by Sanofi. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02999633, a Phase 2 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
Primary Objective: To evaluate the efficacy of isatuximab. Secondary Objectives: * To evaluate the safety profile of isatuximab. * To evaluate the duration of response (DOR). * To evaluate progression free survival (PFS) and overall survival (OS). * To evaluate the pharmacokinetics (PK) of isatuximab in participants with T-ALL or T-LBL. * To evaluate immunogenicity of isatuximab in participants with T-ALL or T-LBL. * To assess minimal residual disease (MRD) and correlate it with clinical outcome.
Primary Outcome
Objective response was defined as percentage of participants with complete response (CR) or with complete response with incomplete peripheral recovery (CRi) as per National Comprehensive Cancer Network (NCCN) guidelines. CR was defined as no circulating blasts or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement, trilineage hematopoiesis and less than 5 percentage blasts, absolute neutrophil count (ANC) greater than
Interventions
- DRUG dexamethasone
- DRUG Isatuximab SAR650984
- DRUG acetaminophen
- DRUG ranitidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2017-03-08 |
| Est. Completion | 2017-11-14 |
| Phase | Phase 2 |
Why NCT02999633 stopped before completion
NCT02999633 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 4 interventions - of which dexamethasone is the first listed.
NCT02999633 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02999633 about?
NCT02999633 is a clinical study titled "Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia". Primary Objective: To evaluate the efficacy of isatuximab. Secondary Objectives: * To evaluate the safety profile of isatuximab. * To evaluate the duration of response (DOR). * To evaluate progression free survival (PFS) and overall survival (OS). * To evaluate the pharmacokinetics (PK) of isatux...
What is the current status of trial NCT02999633?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2017-03-08. Estimated completion is 2017-11-14.
What interventions are being tested in trial NCT02999633?
The interventions under investigation include: dexamethasone (DRUG), Isatuximab SAR650984 (DRUG), acetaminophen (DRUG), ranitidine (DRUG).
Who is sponsoring clinical trial NCT02999633?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02999633's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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