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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: Clinical Trial Phase 2 study, sponsored by Sanofi.
NCT03860844 is a Phase 2 study that was terminated before completion, run by Sanofi. The registered enrollment target is 67 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The complete response rate (CR + CRi \[complete response with incomplete peripheral recovery\]) was defined as the percentage of participants achieving complete response (CR + CRi) assessed by the investigator per National Comprehensive Cancer Network (NCCN) guidelines version 1.2018 criteria. CR was defined as \<5% blasts in a bone marrow aspirate (BMA) with spicules; no circulating blasts (ALL)/no blasts with Auer rods (AML) or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum
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 |
Why NCT03860844 stopped before completion
NCT03860844 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.
NCT03860844 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03860844's enrollment target sits among peer trials
67 974th of 2000 higher than 1,026 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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