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NCT06511882 · ClinicalTrials.gov registry record · Phase 2
Discontinuation of Hypomethylating Agent and Venetoclax in Patients With AML MRD
A Phase 2 study of Acute Myeloid Leukemia, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT06511882: Recruiting Phase 2 study of Acute Myeloid Leukemia, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT06511882 is a Phase 2 study of Acute Myeloid Leukemia that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 37 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06511882, a Phase 2 study of Acute Myeloid Leukemia, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to see if people whose Acute myeloid leukemia (AML) is being successfully treated with azacitidine or decitabine in combination with venetoclax can discontinue this chemotherapy for some period of time after a year of treatment without increasing the likelihood that their AML will return.
Primary Outcome
Rates of CR/CRi at 18 months from the time of initial CR/CRi in patients who discontinue frontline HMA (azacitidine or decitabine)/VEN (venetoclax) after achieving Measurable Residual Disease (MRD) negativity by MFC within 12 months of starting therapy. The Null hypothesis (p0) will be tested against the alternative hypothesis (p1). Null hypothesis: p0 ≤ 50% will remain in CR/CRi at 18 months from the time of initial CR/CRi Alternative hypothesis: p1 ≥ 70% will remain in CR/CRi at 18 months fr
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG Decitabine
Study Locations (1)
Florida
- Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2024-11-07 |
| Est. Completion | 2028-08 |
| Phase | Phase 2 |
What NCT06511882 shows while recruiting
NCT06511882 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT06511882 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06511882 about?
NCT06511882 is a clinical study titled "Discontinuation of Hypomethylating Agent and Venetoclax in Patients With AML MRD". The purpose of this research study is to see if people whose Acute myeloid leukemia (AML) is being successfully treated with azacitidine or decitabine in combination with venetoclax can discontinue this chemotherapy for some period of time after a year of treatment without increasing the likelihood ...
What is the current status of trial NCT06511882?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2024-11-07. Estimated completion is 2028-08.
What conditions does trial NCT06511882 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT06511882?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Decitabine (DRUG).
Who is sponsoring clinical trial NCT06511882?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06511882 being conducted?
This trial has 1 study location across Florida. 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 NCT06511882's enrollment target sits among peer trials
37 182nd of 306 higher than 124 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
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-
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