Optimise viewing for

Toggle between patient and health professional views. The patient version is simplified to help people easily find suitable trials, while the professional view provides full detail.

RecruitingLast updated: 8 August 2025

cAMeLot-2: A study recruiting people with acute myeloid leukaemia (AML) to assess how effective adding a targeted drug called Bleximenib to standard treatment is, compared to a placeboA Phase 3 Randomized, Double-Blind, Placebo-Controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2A Rearrangements or NPM1 Mutations Who Are Ineligible for Intensive Chemotherapy

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

cAMeLot-2

Clinical summary

Summary

You may be eligible for this study if you have newly diagnosed acute myeloid leukaemia (AML) that is harbouring KMT2A rearrangements or NPM1 mutations, and are not eligible for intensive chemotherapy.

Eligible participants will be randomly allocated to one of two treatment arms. 

In Arm A, participants will receive bleximenib (given orally) in combination with oral venetoclax and azacitidine (given intravenously or as an injection under the skin).

In Arm B, participants will receive a placebo that will be given orally, in combination with oral venetoclax and azacitidine (given intravenously or as an injection under the skin).

Conditions

This trial is treating people with acute myeloid leukaemia not eligible for intensive chemotherapy

Eligibility

Inclusion

  • 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 2022 international Consensus Classification criteria
  • Ineligible for intensive chemotherapy based on the following criteria: a) >= 75 years of age and ineligible per physician's discretion, with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, b) >=18 to <75 years of age with >= 1 of the following comorbidities: i) ECOG performance status of 2, ii) Severe cardiac disorder, iii) Severe pulmonary disorder, iv) Renal impairment, v) Comorbidity that, in the investigator's opinion, makes the participant unsuitable for intensive chemotherapy, which must be documented and approved by the sponsor before enrollment defined in the protocol
  • Participants must have adequate hepatic and renal function
  • A female participant must agree not to be pregnant, breast-feed, plan to become pregnant and use protocol-specified contraception while enrolled in this study and for 6 months after the last dose of study treatment
  • A male participant must agree to use protocol-specified contraception while enrolled in this study and for 6 months after the last dose of study treatment
  • Must sign an informed consent form indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion

  • Diagnosis of acute promyelocytic leukemia (APL)
  • Known active leukemic involvement of the central nervous system (CNS)
  • Recipient of solid organ transplant
  • Any cardiac disorders such as heart attack, uncontrolled/unstable chest pain, congestive heart failure, uncontrolled or symptomatic irregular heartbeat, blockage of a blood vessel to brain, or transient ischemic (decreased oxygen in tissue) attack within 6 months of randomization
  • Active infectious hepatitis
  • Live, attenuated vaccine within 4 weeks of randomization
  • Known allergies, hypersensitivity, or intolerance of bleximenib excipients

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

  • NCT06852222 *
  • 75276617AML3001; 75276617AML3001; 2024-520154-38-00

Trial sponsor

Janssen Research & Development, LLC

Scientific Title

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2A Rearrangements or NPM1 Mutations Who Are Ineligible for Intensive Chemotherapy

Get Support

Peer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Know more about Peer Connect

Contact cancer support

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.

Get support

Multilingual information

Learn more about clinical trials through this collection of resources in languages other than English.

View information