E7820 for Leukemia

Palo Alto (17 mi)

Overseen byEytan Stein, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing E7820, a new type of oral medication for treating blood cancers in patients whose cancers have come back or did not respond to previous treatments and have certain genetic changes. The drug works by targeting faulty genetic processes in cancer cells to stop their growth.

Eligibility Criteria

Adults with relapsed or refractory myeloid cancers, specifically AML, MDS, or CMML that have certain splicing factor gene mutations. They must have tried specific treatments without success and should not be pregnant or breastfeeding. Participants need to be in a stable enough condition to follow the study schedule.

Inclusion Criteria

My CMML did not improve after specific treatments.

My CMML cancer has returned after initially responding to treatment.

I am 18 years old or older.

My blood cancer has returned or didn't respond to treatment, and I have a specific genetic mutation.

My kidney function is good and my liver is not severely damaged.

My MDS has returned after initially responding to treatment.

My AML has returned after initial treatment success.

I have tried and cannot tolerate approved treatments for my FLT3, IDH1, or IDH2 mutation.

I can care for myself but may not be able to do heavy physical work.

My AML did not respond to at least two treatment cycles.

Exclusion Criteria

I haven't had serious heart issues like heart failure, heart attack, or stroke in the last 6 months.

I am currently pregnant or breastfeeding.

I have a condition that affects my ability to swallow or absorb pills.

I have been diagnosed with acute promyelocytic leukemia.

I have an ongoing infection that hasn't improved with treatment.

I have severe, life-threatening complications from my blood cancer.

Treatment Details

The trial is testing E7820's effectiveness for those with myeloid cancers who've had previous treatment failures. It focuses on patients whose cancer has returned after remission or hasn't responded to standard therapies.

1Treatment groups

Experimental Treatment

Group I: E7820Experimental Treatment1 Intervention

Each patient will receive daily administration of E7820. The starting dose for every patient will be 100 mg daily but the dose can subsequently be reduced if excessive toxicity is encountered.