Entinostat + 5AC for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byHetty Carraway, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Hetty Carraway

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This research is being done to help us learn how to best use new drugs which may be active against acute myeloid leukemia (AML). Two study drugs will be tested: 5AC (5-azacitidine) and entinostat. 5AC improves blood counts in 50 - 60% of patients with MDS and has also shown promise in AML. Entinostat has undergone early testing in patients with MDS and AML. It has decreased the blast count in some patients' blood and bone marrow and has improved the blood counts in some patients. The combinations of these two classes of drugs are well tolerated and appear to work well together in laboratory tests. A recent study at Johns Hopkins University administered 5AC and entinostat in an overlapping schedule to patients with myelodysplastic syndrome (MDS), Chronic myelomonocytic leukemia (CMMoL), and AML. The impressive results from this study have led to another phase II trial to further examine this drug combination versus 5AC alone in these patients. In this study, we want to see how the timing of when 5AC and entinostat are given affects the magnitude of the disease response.

Eligibility Criteria

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.

Inclusion Criteria

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

Patients must be informed of the investigational nature of the treatment, results that might be expected, and potential toxicities. They must be able to understand and give informed written consent according to federal and institutional guidelines

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

+5 more

Exclusion Criteria

Pregnancy or breast feeding

I have not received AML treatment, except possibly hydroxyurea, in the last 3 weeks.

Concurrent use of any other investigational agents

+11 more

Participant Groups

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.

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.