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NCT05287568 · ClinicalTrials.gov registry record · Phase 1
CC-486 and Venetoclax for Acute Myeloid Leukemia
A Phase 1 study of AML, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 2
- Study locations
NCT05287568: Recruiting Phase 1 study of AML, sponsored by University of Colorado, Denver.
NCT05287568 is a Phase 1 study of AML that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 35 participants, below the 132-participant average among 29 other AML trials with a reported enrollment target (73% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05287568, a Phase 1 study of AML, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is an open label, dose escalation Phase I single institution pilot study for relapsed and refractory AML patients using CC-486 (oral azacitidine) with venetoclax. At the completion of dose escalation and after establishment of the MTD or recommended dose of CC-486 with venetoclax, an expansion phase will commence, using venetoclax with the MTD of CC-486 in relapsed/refractory patients.
Primary Outcome
Standard phase I 3+3 design. The first 3 subjects will be assigned to cohort 1. If none of the first three subjects' experiences DLT, escalation to cohort 2 is permitted. If one of the first three subjects' experiences DLT, a total of six subjects will be required in that dose cohort, and escalation will only be permitted if five of six subjects do not experience DLT. If more than one DLT is observed in the second cohort, this will be determined to be the maximally administered dose, and three m
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG CC-486
Study Locations (2)
Colorado
- CU Anschutz Medical Campus - Aurora
- University of Colorado Hospital - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2022-12-19 |
| Est. Completion | 2029-03 |
| Phase | Phase 1 |
What NCT05287568 shows while recruiting
NCT05287568 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 132-participant average among 29 other AML trials with a reported enrollment target (73% lower).
The record links to 1 condition, with AML appearing as the primary indexed condition, and to 2 interventions - of which Venetoclax is the first listed.
NCT05287568 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT05287568 about?
NCT05287568 is a clinical study titled "CC-486 and Venetoclax for Acute Myeloid Leukemia". This is an open label, dose escalation Phase I single institution pilot study for relapsed and refractory AML patients using CC-486 (oral azacitidine) with venetoclax. At the completion of dose escalation and after establishment of the MTD or recommended dose of CC-486 with venetoclax, an expansion ...
What is the current status of trial NCT05287568?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2022-12-19. Estimated completion is 2029-03.
What conditions does trial NCT05287568 study?
This clinical trial studies the following conditions: AML.
What interventions are being tested in trial NCT05287568?
The interventions under investigation include: Venetoclax (DRUG), CC-486 (DRUG).
Who is sponsoring clinical trial NCT05287568?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05287568 being conducted?
This trial has 2 study locations across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for AML
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 NCT05287568's enrollment target sits among peer trials
35 18th of 29 higher than 12 of 29 other AML trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other AML 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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