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NCT06852222 · ClinicalTrials.gov registry record · Phase 3
A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)
A Phase 3 study of Leukemia, Myeloid, Acute, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 600
- Enrollment target
- 20
- Study locations
NCT06852222: Recruiting Phase 3 study of Leukemia, Myeloid, Acute, sponsored by Janssen Research & Development.
NCT06852222 is a Phase 3 study of Leukemia, Myeloid, Acute that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 600 participants, above the 96-participant average among 30 other Leukemia, Myeloid, Acute trials with a reported enrollment target (525% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06852222, a Phase 3 study of Leukemia, Myeloid, Acute, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 600 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess how bleximenib and Venetoclax (VEN)+ Azacitidine (AZA) works as compared to placebo and VEN+AZA alone for the treatment of participants with newly diagnosed Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene.
Primary Outcome
CR is defined as Bone marrow blasts less than (\<) 5 percent (%); Absence of circulating blasts; Absence of extramedullary disease; Absolute neutrophil count (ANC) greater than or equal to (\>=) 1.0 \* 10\^9/Liter (1,000/microliter \[mcL\]); Platelet count \>= 100 \* 10\^9/L (100,000/mcL).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Bleximenib
- DRUG Venetoclax (VEN)
- DRUG Azacitidine (AZA)
Study Locations (20)
Florida
- Memorial Regional Hospital - Hollywood
- Jupiter Research - Jupiter
- Orlando Health Cancer Institute - Orlando
- Moffit Cancer center - Tampa
- Cleveland Clinic Florida - Weston
Kentucky
- University of Kentucky Markey Cancer Center - Lexington
- UofL Health Brown Cancer Center - Louisville
- Norton Cancer Institute - Louisville
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
- New York Presbyterian - Weill Cornell - New York
- University of Rochester Medical Center - Rochester
Arizona
- Cancer Treatment Center of America Phoenix - Goodyear
Arkansas
- University of Arkansas at Little Rock - Little Rock
California
- City of Hope - Duarte
Illinois
- University of Chicago Medicine - Chicago
Louisiana
- Mary Bird Perkins Cancer Center - Baton Rouge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2025-06-04 |
| Est. Completion | 2029-08-15 |
| Phase | Phase 3 |
What NCT06852222 shows while recruiting
NCT06852222 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 96-participant average among 30 other Leukemia, Myeloid, Acute trials with a reported enrollment target (525% higher).
The record links to 1 condition, with Leukemia, Myeloid, Acute appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT06852222 names 20 study sites across 12 states, led by Florida, Kentucky, New York.
Frequently Asked Questions
What is clinical trial NCT06852222 about?
NCT06852222 is a clinical study titled "A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)". The purpose of this study is to assess how bleximenib and Venetoclax (VEN)+ Azacitidine (AZA) works as compared to placebo and VEN+AZA alone for the treatment of participants with newly diagnosed Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene.
What is the current status of trial NCT06852222?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2025-06-04. Estimated completion is 2029-08-15.
What conditions does trial NCT06852222 study?
This clinical trial studies the following conditions: Leukemia, Myeloid, Acute.
What interventions are being tested in trial NCT06852222?
The interventions under investigation include: Placebo (DRUG), Bleximenib (DRUG), Venetoclax (VEN) (DRUG), Azacitidine (AZA) (DRUG).
Who is sponsoring clinical trial NCT06852222?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06852222 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Leukemia, Myeloid, Acute
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 NCT06852222's enrollment target sits among peer trials
600 1st of 30 higher than 30 of 30 other Leukemia, Myeloid, Acute trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leukemia, Myeloid, Acute 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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