Bleximenib, Venetoclax, and Azacitidine for Acute Myeloid Leukemia

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

Recruiting Phase 3 Interventional Study
Leukemia, Myeloid, Acute
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
600 (estimated)
Sponsor
Janssen Research & Development, LLC · Industry
Who this trial is looking for

This trial is looking for adults with newly diagnosed acute myeloid leukemia that have certain mutations. Participants will receive a combination of medications to see how well they work for treatment compared to other options.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am 18 years of age or older.
  • I have been diagnosed with acute myeloid leukemia with specific gene mutations.
  • I have at least 10% bone marrow blasts.
  • I cannot receive intensive chemotherapy due to my age or health conditions.
  • I have adequate liver and kidney function.
  • I understand the study and agree to participate.
  • I will use contraception during and for 6 months after the study if female.
  • I will use contraception for at least 90 days after the study if male.

You may not be able to join if

  • I have been diagnosed with acute promyelocytic leukemia.
  • I have active leukemic involvement in my central nervous system.
  • I have received a solid organ transplant.
  • I have had serious heart problems in the past 6 months.
  • I have active infectious hepatitis.
  • I have received a live vaccine in the last 4 weeks.
  • I am allergic or sensitive to any study medication.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About 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 newly diagnosed Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene.

Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion criteria: * Be 18 years of age or older at the time of informed consent * Previously untreated lysine N-methyltransferase 2A gene rearranged (KMT2Ar) or nucleophosmin 1 gene mutated (NPM1m) acute myeloid leukemia (AML) with greater than or equal to (\> or =) 10% bone marrow blasts per 202…
Contacts

Study Contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

CONTACT