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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 is a Phase 1 study that has completed, run by Uma Borate. The registered enrollment target is 21 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03900949
The ClinicalTrials.gov registry entry for NCT03900949 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Uma Borate, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Gemtuzumab Ozogamicin is the first listed.
NCT03900949 reports 0 study locations.
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.
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