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NCT03860844 · ClinicalTrials.gov registry record · Phase 2
Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
A Phase 2 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
NCT03860844 is a Phase 2 study that was terminated before completion, run by Sanofi. The registered enrollment target is 67 participants.
The verdict
NCT03860844, a Phase 2 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
Study Summary
Primary Objective: Evaluate the anti-leukemic activity of isatuximab in combination with standard chemotherapies in pediatric participants of ages 28 days to less than 18 years with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML) Secondary Objectives: * Safety and tolerability assessments * Assessment of infusion reactions (IRs) * Pharmacokinetics (PK) of isatuximab * Minimal residual disease * Overall response rate * Overall survival * Event free survival * Duration of response * Relationship between clinical effects and CD38 receptor density and occupancy
Interventions
- DRUG Fludarabine
- DRUG Cytarabine
- DRUG Isatuximab
- DRUG Dexamethasone or equivalent
- DRUG Liposomal daunorubicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2019-08-06 |
| Est. Completion | 2023-05-26 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03860844
The ClinicalTrials.gov registry entry for NCT03860844 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 67 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 5 interventions - of which Fludarabine is the first listed.
NCT03860844 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03860844 about?
NCT03860844 is a clinical study titled "Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia". Primary Objective: Evaluate the anti-leukemic activity of isatuximab in combination with standard chemotherapies in pediatric participants of ages 28 days to less than 18 years with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML) Secondary Objectives: * Safe...
What is the current status of trial NCT03860844?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2019-08-06. Estimated completion is 2023-05-26.
What interventions are being tested in trial NCT03860844?
The interventions under investigation include: Fludarabine (DRUG), Cytarabine (DRUG), Isatuximab (DRUG), Dexamethasone or equivalent (DRUG), Liposomal daunorubicin (DRUG).
Who is sponsoring clinical trial NCT03860844?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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