Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

NCT06852222 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 600 participants
Start Date 2025-06-04
Est. Completion 2029-08-15
Phase Phase 3

Sponsor

Janssen Research & Development

442 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06852222

The ClinicalTrials.gov registry entry for NCT06852222 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06852222 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, Kentucky, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06852222?

The interventions under investigation include: Placebo (DRUG), Bleximenib (DRUG), Venetoclax (VEN) (DRUG), Azacitidine (AZA) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06852222?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial