Revumenib for Leukemia

Recruiting in Palo Alto (17 mi)

Ghayas C. Issa | MD Anderson Cancer Center

Overseen byGhayas Issa, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Chemotherapy, Antileukemics

Disqualifiers: Uncontrolled infection, Active malignancy, HIV, others

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?To learn if revumenib (also known as SNDX-5613) can help to control leukemias associated with an increase in expression of HOX genes.

Do I need to stop my current medications to join the trial?

The trial does not allow the use of other chemotherapeutic or anti-leukemic agents during the study, except for specific cases like intrathecal chemotherapy for CNS leukemia or hydroxyurea for rapidly proliferative disease. If you're on these types of medications, you may need to stop them, but other medications are not specifically mentioned.

Eligibility Criteria

This trial is for individuals with leukemia that's linked to high activity of HOX genes. Specific eligibility details are not provided, but typically participants would need a confirmed diagnosis and may have to meet certain health requirements.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

My leukemia has returned or is not responding to treatment and has specific genetic changes.

My white blood cell count is below 25,000/uL.

+7 more

Exclusion Criteria

I currently have an infection that isn't under control.

My leukemia is affecting my brain or spinal cord.

I have severe acute or chronic GVHD.

+10 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take revumenib 2 times a day, every day of each 28-day study cycle

12 months

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The study is testing the effectiveness of Revumenib, a Menin inhibitor, in managing leukemia where there's an upregulation of HOX genes. It aims to determine if this drug can control the disease.

1Treatment groups

Experimental Treatment

Group I: Arm 1Experimental Treatment1 Intervention

Participants found to be eligible to take part in this study, will take revumenib 2 times a day (each dose about 12 hours apart), every day of each 28-day study cycle.

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