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NCT05780879 · ClinicalTrials.gov registry record · Phase 2
A Proof of Concept Pilot Study of the Addition of Venetoclax to Standard Remission Induction Chemotherapy Fludarabine or Cladrabine, Cytarabine, and Granulocyte Colony Stimulating Factor (G-CSF) (FLAG or CLAG) for Frontline Therapy of Secondary Acute Myeloid Leukemia
A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT05780879: Clinical Trial Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
NCT05780879 is a Phase 2 study that was terminated before completion, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05780879, a Phase 2 study, was terminated before completion, sponsored by University of Michigan Rogel Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
The primary purpose of this study is to determine complete remission rate of a novel combination induction chemotherapy treatment based upon 20 patients with newly diagnosed secondary AML.
Primary Outcome
If at least 12/20 (60%) of patients achieve a CR (based upon a bone marrow aspiration, biopsy, and peripheral blood studies according to the International Working Group criteria for AML), the combination treatment will be considered successful. If the true CR rate is 40%, then the trial will be considered successful with probability 0.06 (type I error). Conversely, if the true CR rate is 70%, then the trial will be considered successful with probability 0.89 (power).
Interventions
- DRUG Venetoclax
- DRUG FLAG or CLAG Protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2024-06-03 |
| Est. Completion | 2025-08-16 |
| Phase | Phase 2 |
Why NCT05780879 stopped before completion
NCT05780879 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Venetoclax is the first listed.
NCT05780879 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05780879 about?
NCT05780879 is a clinical study titled "A Proof of Concept Pilot Study of the Addition of Venetoclax to Standard Remission Induction Chemotherapy Fludarabine or Cladrabine, Cytarabine, and Granulocyte Colony Stimulating Factor (G-CSF) (FLAG or CLAG) for Frontline Therapy of Secondary Acute Myeloid Leukemia". The primary purpose of this study is to determine complete remission rate of a novel combination induction chemotherapy treatment based upon 20 patients with newly diagnosed secondary AML.
What is the current status of trial NCT05780879?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2024-06-03. Estimated completion is 2025-08-16.
What interventions are being tested in trial NCT05780879?
The interventions under investigation include: Venetoclax (DRUG), FLAG or CLAG Protocol (DRUG).
Who is sponsoring clinical trial NCT05780879?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05780879's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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