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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 is a Phase 2 study that was terminated before completion, run by Sanofi. The registered enrollment target is 14 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02999633
The ClinicalTrials.gov registry entry for NCT02999633 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which dexamethasone is the first listed.
NCT02999633 reports 0 study locations.
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.
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