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NCT03900949 · ClinicalTrials.gov registry record · Phase 1
Gentuzumab Ozogamicin and Midostaurin Combination With Standard Cytarabine and Danunorubi Midostaurin as a Novel Approach to Treating Patients With Newly Diagnosed FLT-3 Mutated Acute Myeloid Leukemia
A Phase 1 study, sponsored by Uma Borate.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT03900949: Completed Phase 1 study, sponsored by Uma Borate.
NCT03900949 is a Phase 1 study that has completed, run by Uma Borate. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03900949, a Phase 1 study, has completed, sponsored by Uma Borate.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
This phase I study hopes to explore how safe and tolerable is the combination of gemtuzumab ozogamicin (GO) and midostaurin, with the standard induction therapy (cytarabine and daunorubicin) in patients with newly diagnosed FLT-3 mutated Acute Myeloid Leukemia (AML). GO is FDA approved for the treatment of adults with newly diagnosed CD33 positive AML and used in combination with chemotherapy, cytarabine and daunorubicin. Midostaurin is FDA approved for use with cytarabine and daunorubicin in patients with FLT3-mutated AML. By combining standard induction therapy with GO and midostaurin, our aim is to investigate a novel approach to treating patients with newly diagnosed FLT3-mutated AML.
Primary Outcome
The MTD will be estimated using isotonic regression. An incidence of dose limiting toxicity at each dose level will be summarized.
Interventions
- DRUG Gemtuzumab Ozogamicin
- DRUG Cytarabine
- DRUG Midostaurin
- DRUG Daunorubicin Hydrochloride
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2019-03-13 |
| Est. Completion | 2025-10-23 |
| Phase | Phase 1 |
What the finished NCT03900949 record still lists
NCT03900949 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 5 interventions - of which Gemtuzumab Ozogamicin is the first listed.
NCT03900949 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03900949 about?
NCT03900949 is a clinical study titled "Gentuzumab Ozogamicin and Midostaurin Combination With Standard Cytarabine and Danunorubi Midostaurin as a Novel Approach to Treating Patients With Newly Diagnosed FLT-3 Mutated Acute Myeloid Leukemia". This phase I study hopes to explore how safe and tolerable is the combination of gemtuzumab ozogamicin (GO) and midostaurin, with the standard induction therapy (cytarabine and daunorubicin) in patients with newly diagnosed FLT-3 mutated Acute Myeloid Leukemia (AML). GO is FDA approved for the treat...
What is the current status of trial NCT03900949?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2019-03-13. Estimated completion is 2025-10-23.
What interventions are being tested in trial NCT03900949?
The interventions under investigation include: Gemtuzumab Ozogamicin (DRUG), Cytarabine (DRUG), Midostaurin (DRUG), Daunorubicin Hydrochloride (DRUG), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT03900949?
This trial is sponsored by Uma Borate, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03900949's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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