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

Phase 3

Not yet recruiting

• Conditions: Leukemia, Myeloid, Acute
• Interventions: Drug: Bleximenib; Drug: Venetoclax (VEN); Drug: Azacitidine (AZA); Drug: Placebo

• Registration Number: NCT06852222
• Lead Sponsor: Janssen Research & Development, LLC

Brief 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 Acute Myeloid Leukemia (AML).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-02-25
• Study First Posted: 2025-02-28
• Study Start: 2025-04-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-04
• Primary Completion: 2029-06-22
• Study Completion: 2029-08-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: Bleximenib and Venetoclax (VEN) + Azacitidine (AZA)	Bleximenib	Participants with acute myeloid leukemia (AML) will receive bleximenib in combination with venetoclax (VEN) and azacitidine (AZA) for 28-days treatment cycle and treatment will continue until progression or unacceptable toxicity.
Arm A: Bleximenib and Venetoclax (VEN) + Azacitidine (AZA)	Venetoclax (VEN)	Participants with acute myeloid leukemia (AML) will receive bleximenib in combination with venetoclax (VEN) and azacitidine (AZA) for 28-days treatment cycle and treatment will continue until progression or unacceptable toxicity.
Arm A: Bleximenib and Venetoclax (VEN) + Azacitidine (AZA)	Azacitidine (AZA)	Participants with acute myeloid leukemia (AML) will receive bleximenib in combination with venetoclax (VEN) and azacitidine (AZA) for 28-days treatment cycle and treatment will continue until progression or unacceptable toxicity.
Arm B: Placebo and Venetoclax (VEN) + Azacitidine (AZA)	Venetoclax (VEN)	Participants with AML will receive placebo in combination with VEN and AZA for 28-days treatment cycle, and treatment will continue until progression or unacceptable toxicity.
Arm B: Placebo and Venetoclax (VEN) + Azacitidine (AZA)	Placebo	Participants with AML will receive placebo in combination with VEN and AZA for 28-days treatment cycle, and treatment will continue until progression or unacceptable toxicity.
Arm B: Placebo and Venetoclax (VEN) + Azacitidine (AZA)	Azacitidine (AZA)	Participants with AML will receive placebo in combination with VEN and AZA for 28-days treatment cycle, and treatment will continue until progression or unacceptable toxicity.
Arm B: Placebo and Venetoclax (VEN) + Azacitidine (AZA)	Bleximenib	Participants with AML will receive placebo in combination with VEN and AZA for 28-days treatment cycle, and treatment will continue until progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants who Achieve Complete Remission (CR)	Up to 4 years and 1 month	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).
Overall Survival (OS)	Up to 4 years and 1 month	Overall survival time is defined as the time duration from the date of randomization to death due to any cause.

Secondary Outcome Measures

Name	Time	Method
Time to CR	Up to 4 years and 1 month	Time to CR is defined as time from randomization to first documented response.
Number of Participants with Adverse Events (AEs)	Up to 4 years and 1 month	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Event-free survival (EFS)	Up to 4 years and 1 month	EFS is defined as the time from randomization to treatment failure, relapse, or death due to any cause, whichever occurs first.
Duration of CR	Up to 4 years and 1 month	Duration of CR will be estimated among responders from the date of initial documentation of CR, to the date of first documented evidence of relapse, or death due to any cause, whichever occurs first, respectively.
Rate of CR-Measurable Residual Disease (MRD)	Up to 4 years and 1 month	Rate of CR-MRD is defined as percentage of participants who have achieved CR-MRD.
Percentage of Participants who Achieved Transfusion Independence	Up to 4 years and 1 month	Transfusion independence is defined as lack of requirement for red blood cell (RBC) and platelet transfusions during any 56-day period.
Percentage of Participants with Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)	Up to 4 years and 1 month	Allo-HSCT is defined as the percentage of participants who have undergone allo-HSCT after randomization.
Number of Participants with Abnormalities in Clinical Laboratory Parameters	Up to 4 years and 1 month	Participants with abnormalities in clinical laboratory parameters will be reported.
Serum Concentration of Bleximenib	Up to 4 years and 1 month	Serum samples will be analyzed to determine concentrations of bleximenib.

Trial Locations

Locations (1)

Hadassah University Hospita Ein Kerem; 🇮🇱 Jerusalem, Israel