Revumenib for Acute Leukemia

Overseen By Brian Ball, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: City of Hope Medical Center

Must be taking: CYP3A4 inhibitors

Must not be taking: QT prolonging medications

Disqualifiers: Acute promyelocytic leukemia, HIV, Hepatitis B/C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: Up to 2 years

27 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase I trial tests the safety, side effects, best dose and effectiveness of revumenib in treating patients with acute leukemia after allogeneic stem cell transplant. Revumenib is in a class of medications called menin inhibitors. Revumenib targets and binds to the protein menin, thereby preventing the interaction between menin and the mixed lineage leukemia protein. Disrupting this interaction prevents the activation of specific genes that fuel the development of leukemia cells and inhibits the survival, growth, and production of certain kinds of leukemia cells. Giving revumenib may be safe, tolerable, and/or effective in treating patients with acute leukemia after allogeneic stem cell transplant.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be able to take a strong CYP3A4 inhibiting antifungal at least 7 days before starting revumenib, and you cannot use medications known to prolong the QT interval, except for certain low-risk drugs used as standard supportive therapies.

Research Team

Brian Ball, MD

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for patients with acute leukemia who have undergone an allogeneic stem cell transplant. It's designed to test the safety and effectiveness of a new medication called revumenib, which targets proteins that help leukemia cells grow.

Inclusion Criteria

I am a woman who can have children, not pregnant, and agree to use birth control.

Any donor or graft source will be included

I have been treated with menin inhibitors before my stem cell transplant.

Exclusion Criteria

I have not had a stem cell transplant for acute promyelocytic leukemia.

I can take strong CYP3A4 inhibitors and do not need medications that prolong the QT interval.

History of or concurrent conditions that may confound study results or interfere with participation are exclusion criteria

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive revumenib orally once daily or every 12 hours on days 1-28 of each cycle. Cycles repeat every 28 days for up to 2 years.

Up to 2 years

Regular visits for bone marrow aspiration and blood sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 30 days and then every 3 months for up to 2 years.

Up to 2 years

Follow-up visits every 3 months

Treatment Details

Interventions

• Revumenib

Trial Overview The study involves testing revumenib, a menin inhibitor drug, to determine its best dose and how well it can treat acute leukemia post-transplant. The trial includes various assessments like bone marrow tests, heart scans (echocardiography), and health questionnaires.

Participant Groups

Group I: Treatment (revumenib) Experimental Treatment 8 Interventions

Starting 50-150 days after alloHCT, patients receive revumenib PO QD or every 12 hours on days 1-28 of each cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo bone marrow biopsy during screening and may undergo ECHO during screening and as clinically indicated. Patients also undergo bone marrow aspiration and collection of blood samples throughout the trial.

Revumenib is already approved in United States for the following indications:

Approved in United States as Revuforj for:

• Relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients aged 1 year and older

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+