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Study details
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A Phase 1/2 Trial of Bleximenib for Acute Leukemia

Janssen Research & Development, LLC
NCT IDNCT04811560ClinicalTrials.gov data as of Apr 2026
Phase

Phase 1/2

Target enrollment

400

Study length

about 7 years

Ages

2+

Locations

27 sites in AZ, CA, IL +14

What this study is about

This trial is testing a treatment called bleximenib in people with acute leukemia. The goal is to find the best dose that's safe and effective, and then evaluate how well it works at that dose.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take Bleximenib

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Standard

How treatment is administered

Treatment Assignment
Standard assignment

Assignment is predetermined by the study protocol.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

kinase inhibitor

Endpoints

Primary: Phase 1: Number of Participants with AEs by Severity, Phase 1: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability, Phase 1: Part 1: Percentage of Participants with Dose-Limiting Toxicity (DLT), Phase 2: Rate of Complete Remission or Complete Remission with Partial Hematologic Recovery (CR/CRh)

Secondary: Phase 1 and 2: Overall Response Rate (ORR), Phase 1: Duration of Response (DOR), Phase 2: Duration of Complete Response (CR)/Complete Remission With Partial Hematologic Recovery (CRh), Phase 2: Event-free survival (EFS), Phase 2: Measurable Residual Disease (MRD) Negativity Among Participants Achieving CR/CRh/CRi, Phase 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Phase 2: Overall survival (OS), Phase 2: Time To CR/CRh

Body systems

Oncology