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Anti-metabolites

Entinostat + 5AC for Acute Myeloid Leukemia

Phase 2

Waitlist Available

Led By Hetty Carraway, MD

Research Sponsored by Hetty Carraway

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Normal organ function as defined below: Creatinine < 2 mg/dl, Total serum bilirubin within institutional limits unless due to hemolysis, Gilbert's syndrome, or ineffective erythropoiesis, AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal, Life expectancy of at least three months

ECOG performance status 0, 1, or 2

Must not have

Hypersensitivity to azacytidine, deoxyazacytidine, mannitol, entinostat or components of the entinostat tablet

Clinical evidence of CNS or pulmonary leukostasis, disseminated intravascular coagulation, or central nervous system leukemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is researching how best to use two drugs to help treat acute myeloid leukemia (AML). Results so far have been promising.

Who is the study for?

This trial is for elderly patients with Acute Myeloid Leukemia who can't undergo standard chemotherapy, have a life expectancy of at least three months, and are not suitable for stem cell transplant. They must understand the study's nature and give consent. Participants should not have active infections or recent treatments that could interfere with the study.

What is being tested?

The trial tests two drugs, 5AC (5-azacitidine) and entinostat, to see how they work together against AML when given on different schedules. The goal is to find out if changing the timing of these drugs improves patient outcomes compared to previous studies where they were administered simultaneously.

What are the potential side effects?

Potential side effects include blood count changes, organ inflammation due to immune response, fatigue from treatment-related stress on the body, digestive issues like nausea or constipation from medication interactions, and increased risk of infection due to weakened immunity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I do not have any untreated active infections.

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I am not eligible for or have declined a stem cell transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not allergic to azacytidine, deoxyazacytidine, mannitol, or entinostat.

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I have complications like blood clots or leukemia affecting my brain or lungs.

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I do not have any serious or uncontrolled health issues.

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I agree to use effective birth control during and for 30 days after the study.

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I have been diagnosed with acute promyelocytic leukemia.

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I still experience side effects from previous treatments.

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I have advanced liver cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: B: 5AC days 1-10 / entinostat days 10,17Experimental Treatment2 Interventions

In Arm B the agents will be administered sequentially with 5AC given at 50mg/m2 subcutaneously daily for 10 days on days 1 - 10 of a 28 day cycle followed by entinostat at a 8 mg flat dose on days 10 and 17.

Group II: A: 5AC days 1-10 / entinostat days 3, 10Experimental Treatment2 Interventions

Arm A will be given an overlapping schedule of drugs with 5AC given at 50mg/m2 subcutaneously daily for 10 days on days 1 - 10 of a 28 day cycle and entinostat given at a flat dose of 8 mg orally on days 3 and 10.

0 / 11Eligibility criteria met