JNJ-75276617 for Acute Leukemia

Recruiting in Palo Alto (17 mi)

+82 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Janssen Research & Development, LLC

Must not be taking: Immunotherapy, Blinatumomab

Disqualifiers: Down syndrome leukemia, CNS disease, others

No Placebo Group

Trial Summary

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.

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.

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.

+3 more

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)

+3 more

Trial 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

Participant Groups

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).

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.