400 Participants Needed
Janssen Research & Development, LLC logo

JNJ-75276617 for Acute Leukemia

Recruiting in Detroit (>99 mi)
+100 other locations
SC
Overseen ByStudy Contact
Age: Any Age
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Janssen Research & Development, LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have had prior cancer immunotherapy within 4 weeks before joining the trial, and other cancer therapies must not be given within 4 weeks or 5 half-lives of the agent, whichever is shorter.

What is the purpose of this trial?

This trial tests JNJ-75276617, an oral drug designed to block a protein interaction that helps leukemia cells grow. It targets patients with specific genetic types of AML or ALL. By stopping these proteins from working together, the drug aims to slow down or stop cancer cell growth.

Research Team

JR

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

This trial is for adults with acute leukemia who have specific genetic alterations (KMT2A or NPM1), and whose disease has not improved after treatment, or they can't receive standard treatments. They must be in relatively good health otherwise, with acceptable blood counts and organ function. Women of childbearing age and men must agree to use contraception.

Inclusion Criteria

A woman of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment
I agree to use a condom and not donate sperm during and 90 days after the study.
I can take care of myself and am up and about more than half of my waking hours.
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Exclusion Criteria

I have been diagnosed with a specific type of leukemia.
My heart's electrical cycle length is within safe limits and I don't have a family history of Long QT syndrome.
Exclusion criteria related to stem cell transplant: a. Willing and able to undergo allogeneic stem cell transplant (if clinically indicated); b. Received prior treatment with allogenic bone marrow or stem cell transplant <=3 months before the first dose of study treatment; c. Has evidence of graft versus host disease; d. Received donor lymphocyte infusion <=1 month before the first dose of study treatment; e. Requires immunosuppressant therapy (exception: daily doses <=10 milligrams (mg) prednisone or equivalent are allowed for adrenal replacement)
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive bleximenib orally with dose levels escalated based on dose limiting toxicities evaluation

Up to 28 days

Dose Expansion

Participants receive bleximenib orally at the recommended Phase 2 dose(s) determined in Dose Escalation

Up to 4 years and 9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • JNJ-75276617
Trial Overview The study is testing JNJ-75276617 to find the safest dose that's also effective (Phase 2). It starts by increasing doses (Part 1) then tests this dose further for safety and effectiveness (Part 2).
Participant Groups
1Treatment groups
Experimental Treatment
Group I: BleximenibExperimental Treatment1 Intervention
Participants in Phase 1 Part 1 (dose escalation) will receive bleximenib orally. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by Study Evaluation Team (SET) until the recommended Phase 2 Doses (RP2Ds) have been identified. Participants in Phase 1 Part 2 (dose expansion) will receive bleximenib orally at the RP2D(s) determined in Part 1.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC logo

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Giacomo Salvadore profile image

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar profile image

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires

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