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NCT04128501 · ClinicalTrials.gov registry record · Phase 2
Venetoclax and Azacitidine for the Treatment of Acute Myeloid Leukemia in the Post-Transplant Setting
A Phase 2 study of Acute Myeloid Leukemia and Mixed Phenotype Acute Leukemia, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT04128501: Active Phase 2 study of Acute Myeloid Leukemia and Mixed Phenotype Acute Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT04128501 is a Phase 2 study of Acute Myeloid Leukemia and Mixed Phenotype Acute Leukemia that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 100 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (14% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04128501, a Phase 2 study of Acute Myeloid Leukemia and Mixed Phenotype Acute Leukemia, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well venetoclax and azacitidine work for the treatment of acute myeloid leukemia after stem cell transplantation. Venetoclax may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Chemotherapy drugs, 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. Giving venetoclax and azacitidine after a stem cell transplant may help control high risk leukemia and prevent it from coming back after the transplant.
Primary Outcome
Summary statistics for RFS time will be computed for all patients and within each (disease status, disease type) subgroup. RFS time distributions will be estimated within each subgroup using the method of Kaplan and Meier.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2020-05-05 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04128501 still lists
NCT04128501 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (14% lower).
The record links to 6 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Venetoclax is the first listed.
NCT04128501 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04128501 about?
NCT04128501 is a clinical study titled "Venetoclax and Azacitidine for the Treatment of Acute Myeloid Leukemia in the Post-Transplant Setting". This phase II trial studies how well venetoclax and azacitidine work for the treatment of acute myeloid leukemia after stem cell transplantation. Venetoclax may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as azacitidine, work...
What is the current status of trial NCT04128501?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2020-05-05. Estimated completion is 2026-12-31.
What conditions does trial NCT04128501 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Mixed Phenotype Acute Leukemia, Acute Biphenotypic Leukemia, Therapy-Related Acute Myeloid Leukemia, T Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT04128501?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG).
Who is sponsoring clinical trial NCT04128501?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04128501 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 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 NCT04128501's enrollment target sits among peer trials
100 79th of 306 higher than 223 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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
-
Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure
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