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NCT04140487 · ClinicalTrials.gov registry record · Phase 1
Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm
A Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 97
- Enrollment target
- 1
- Study location
NCT04140487 is a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 97 participants, above the 46-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (111% higher). The trial reports 1 study location across 1 state.
The verdict
NCT04140487, a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 97 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies the side effects and best dose of gilteritinib and to see how well it works in combination with azacitidine and venetoclax in treating patients with FLT3-mutation positive acute myeloid leukemia, chronic myelomonocytic leukemia, or high-risk myelodysplastic syndrome/myeloproliferative neoplasm that has come back (recurrent) or has not responded to treatment (refractory). Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gilteritinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine, venetoclax, and gilteritinib may work better compared to azacitidine and venetoclax alone in treating patients with acute myeloid leukemia, chronic myelomonocytic leukemia, or myelodysplastic syndrome/myeloproliferative neoplasm.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG Gilteritinib
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2019-12-17 |
| Est. Completion | 2028-09-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04140487
The ClinicalTrials.gov registry entry for NCT04140487 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 46-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (111% higher). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Refractory Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT04140487 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT04140487 about?
NCT04140487 is a clinical study titled "Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm". This phase I/II trial studies the side effects and best dose of gilteritinib and to see how well it works in combination with azacitidine and venetoclax in treating patients with FLT3-mutation positive acute myeloid leukemia, chronic myelomonocytic leukemia, or high-risk myelodysplastic syndrome/mye...
What is the current status of trial NCT04140487?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 97 participants. The study started on 2019-12-17. Estimated completion is 2028-09-01.
What conditions does trial NCT04140487 study?
This clinical trial studies the following conditions: Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Recurrent Chronic Myelomonocytic Leukemia, Refractory Chronic Myelomonocytic Leukemia, Recurrent Myelodysplastic/Myeloproliferative Neoplasm.
What interventions are being tested in trial NCT04140487?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Gilteritinib (DRUG).
Who is sponsoring clinical trial NCT04140487?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04140487 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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