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NCT04746235 · ClinicalTrials.gov registry record · Phase 2
Venetoclax and ASTX727 for the Treatment of Relapsed, Refractory, or Newly Diagnosed Acute Myeloid Leukemia
A Phase 2 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 85
- Enrollment target
- 1
- Study location
NCT04746235: Active Phase 2 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT04746235 is a Phase 2 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 85 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (27% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04746235, a Phase 2 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 85 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies the possible benefits of venetoclax and ASTX727 in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory), or elderly patients with newly diagnosed acute myeloid leukemia who are not candidates for intensive chemotherapy. Venetoclax may help block the formation of growths that may become cancer. ASTX727 is the combination of a fixed dose of 2 drugs, cedazuridine and decitabine. Cedazuridine may slow down how fast decitabine is broken down by the body, and decitabine may block abnormal cells or cancer cells from growing. Giving venetoclax and ASTX727 may help to control the disease.
Primary Outcome
Will be defined as the proportion of patients who had CR (complete remission), CRp (complete remission with incomplete platelet recovery), CRi (complete remission with incomplete count recovery), PR (partial response) or marrow clearance of blasts within 3 months of treatment initiation among adult patients with acute myeloid leukemia (AML). Response criteria will be modified from the International Working Group for AML. Will estimate the ORR for the combination treatments for each cohort, along
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Decitabine and Cedazuridine
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2021-02-22 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 2 |
What the registry record for NCT04746235 still lists
NCT04746235 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (27% lower).
The record links to 3 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Venetoclax is the first listed.
NCT04746235 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04746235 about?
NCT04746235 is a clinical study titled "Venetoclax and ASTX727 for the Treatment of Relapsed, Refractory, or Newly Diagnosed Acute Myeloid Leukemia". This phase II trial studies the possible benefits of venetoclax and ASTX727 in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory), or elderly patients with newly diagnosed acute myeloid leukemia who are not candidates for intensi...
What is the current status of trial NCT04746235?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 85 participants. The study started on 2021-02-22. Estimated completion is 2026-10-31.
What conditions does trial NCT04746235 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia.
What interventions are being tested in trial NCT04746235?
The interventions under investigation include: Venetoclax (DRUG), Decitabine and Cedazuridine (DRUG).
Who is sponsoring clinical trial NCT04746235?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04746235 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 NCT04746235's enrollment target sits among peer trials
85 92nd of 306 higher than 215 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
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Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure
RECRUITING · Phase 2
-
Venetoclax + Azacitidine vs. Induction Chemotherapy in AML
RECRUITING · Phase 2
-
A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)
RECRUITING · Phase 2
-
Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission
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-
A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
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-
Venetoclax, Cladribine, Low Dose Cytarabine, and Azacitidine in Treating Patients With Previously Untreated Acute Myeloid Leukemia
RECRUITING · Phase 2
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