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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: Recruiting Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, sponsored by M.D. Anderson Cancer Center.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The MTD is the highest dose level in which \< 2 patients of 6 develop first cycle dose-limiting toxicity.

Conditions Studied

Refractory Acute Myeloid Leukemia Recurrent Acute Myeloid Leukemia Recurrent Chronic Myelomonocytic Leukemia Refractory Chronic Myelomonocytic Leukemia Recurrent Myelodysplastic/Myeloproliferative Neoplasm Refractory Myelodysplastic/Myeloproliferative Neoplasm

Interventions

  • DRUG Venetoclax
  • DRUG Azacitidine
  • DRUG Gilteritinib

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 97 participants
Start Date 2019-12-17
Est. Completion 2028-09-01
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What NCT04140487 shows while recruiting

NCT04140487 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, above the 46-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (111% higher).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Refractory Acute Myeloid Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04140487's enrollment target sits among peer trials

97 7th of 63 higher than 57 of 63 other Refractory Acute Myeloid Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Refractory Acute Myeloid Leukemia 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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More recruiting context for NCT04140487

Source: ClinicalTrials.gov NCT04140487, the US trial registry maintained by the National Library of Medicine. NCT04140487 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.