Bleximenib + Venetoclax + Azacitidine for Acute Myeloid Leukemia

(cAMeLot-2 Trial)

Recruiting at 14 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Disqualifiers: Acute promyelocytic leukemia, CNS involvement, organ transplant, cardiac disorders, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 28-day cycles

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

This trial is for adults with previously untreated Acute Myeloid Leukemia (AML) that have specific genetic changes. They must have good liver and kidney function, not be pregnant or breastfeeding, agree to use contraception, and understand the study.

Inclusion Criteria

I have AML with specific genetic changes and at least 10% bone marrow blasts.

My liver and kidney functions are normal.

I am not pregnant or breastfeeding and agree to use contraception during and for 6 months after the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Bleximenib with Venetoclax and Azacitidine or Placebo with Venetoclax and Azacitidine in 28-day cycles until progression or unacceptable toxicity

28-day cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 4 years and 1 month

What Are the Treatments Tested in This Trial?

Interventions

• Azacitidine
• Bleximenib
• Venetoclax

Trial Overview The study is testing Bleximenib in combination with Venetoclax (VEN) and Azacitidine (AZA), comparing it to a placebo plus VEN+AZA to see how well they work in treating AML patients.

How Is the Trial Designed?

Group I: Arm A: Bleximenib and Venetoclax (VEN) + Azacitidine (AZA) Experimental Treatment 3 Interventions

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.

Group II: Arm B: Placebo and Venetoclax (VEN) + Azacitidine (AZA) Placebo Group 4 Interventions

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.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University