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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

About this study

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.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take Bleximenib
PhasePhase 1/Phase 2
DrugBleximenib
Primary goalPhase 1: Number of Participants with AEs by Severity

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low10%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

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