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NCT06660368 · ClinicalTrials.gov registry record · Phase 2
BCL2i CLAG-M in R/R Acute Myeloid Leukemia
A Phase 2 study of Relapsed or Refractory Acute Myeloid Leukemia (AML), sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
- 2
- Study locations
NCT06660368: Recruiting Phase 2 study of Relapsed or Refractory Acute Myeloid Leukemia (AML), sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT06660368 is a Phase 2 study of Relapsed or Refractory Acute Myeloid Leukemia (AML) that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06660368, a Phase 2 study of Relapsed or Refractory Acute Myeloid Leukemia (AML), is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
- 2
- Study locations
Study Summary
This multicenter, open-label phase II study combines CLAG-based therapy with or without venetoclax in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) in order to improve measurable residual disease (MRD) clearance and event-free survival. Investigators hypothesize that the addition of venetoclax to CLAG-M in patients with relapsed or refractory AML is safe, and superior to CLAG-M alone in improving patient outcomes.
Primary Outcome
The rate of MRD negative remission will be calculated for each arm.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Cladribine, Cytarabine, Mitoxantrone, G-CSF (CLAG-M) regimen
Study Locations (2)
Florida
- Moffitt Cancer Center - Tampa
Massachusetts
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2024-11-26 |
| Est. Completion | 2027-11 |
| Phase | Phase 2 |
What NCT06660368 shows while recruiting
NCT06660368 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Relapsed or Refractory Acute Myeloid Leukemia (AML) appearing as the primary indexed condition, and to 2 interventions - of which Venetoclax is the first listed.
NCT06660368 reports a single indexed study location in Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06660368 about?
NCT06660368 is a clinical study titled "BCL2i CLAG-M in R/R Acute Myeloid Leukemia". This multicenter, open-label phase II study combines CLAG-based therapy with or without venetoclax in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) in order to improve measurable residual disease (MRD) clearance and event-free survival. Investigators hypothesize that the ad...
What is the current status of trial NCT06660368?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2024-11-26. Estimated completion is 2027-11.
What conditions does trial NCT06660368 study?
This clinical trial studies the following conditions: Relapsed or Refractory Acute Myeloid Leukemia (AML).
What interventions are being tested in trial NCT06660368?
The interventions under investigation include: Venetoclax (DRUG), Cladribine, Cytarabine, Mitoxantrone, G-CSF (CLAG-M) regimen (DRUG).
Who is sponsoring clinical trial NCT06660368?
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 NCT06660368 being conducted?
This trial has 2 study locations across Florida, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06660368's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 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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