Study on Two Schedules of MS275 and 5AC for Treating Acute Myeloid Leukemia in Older Adults

Sponsor: Hetty Carraway

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01305499

Provider View

This clinical trial is testing two different schedules of combining the drugs 5AC and entinostat to see which works better for older adults with acute myeloid leukemia (AML) who cannot tolerate or choose not to have standard chemotherapy.

Patient Parameters

Program Overview

The purpose of this study is to find out how to best use two drugs, 5AC and entinostat, to treat acute myeloid leukemia (AML) in older adults. 5AC has been shown to improve blood counts in some patients, and entinostat has shown promise in reducing cancer cells in the blood and bone marrow. This study will test two different schedules of giving these drugs together to see which is more effective in controlling the disease.

Description

This study aims to find out how well two different schedules of the drugs 5AC and entinostat work in treating older adults with acute myeloid leukemia (AML) who cannot or choose not to have standard chemotherapy. The study will look at how many patients have a major response to the treatment, meaning their cancer significantly shrinks or disappears. It will also look at overall response rates, including improvements in blood counts.

The study will also explore how the drugs affect gene activity and DNA damage in cancer cells, and how these changes relate to treatment outcomes. Researchers will also study how the drugs affect the immune system and how long the treatment response lasts.

Participants will receive one of two treatment schedules: 5AC given for 10 days with entinostat on days 3 and 10, or 5AC for 10 days with entinostat on days 10 and 17. The study will help determine which schedule is more effective and better tolerated.

Eligibility Criteria

Inclusion Criteria

  • Have untreated acute myeloid leukemia (AML) and cannot or choose not to have standard chemotherapy.
  • Have AML that has returned after one previous treatment.
  • Be in good overall health with an ECOG performance status of 0, 1, or 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have no untreated active infections.
  • Have normal organ function, including:
    • Creatinine level less than 2 mg/dL.
    • Normal bilirubin levels unless due to specific conditions.
    • Liver enzymes (AST/ALT) within 2.5 times the normal limit.
  • Have a life expectancy of at least three months.
  • Understand the study and agree to sign informed consent.
  • Have declined or are not eligible for potentially curative treatments like stem cell transplant.
  • Have not received chemotherapy or study drugs in the last three weeks.
  • Agree to use effective birth control during the study and for 30 days after treatment if of childbearing potential.

Exclusion Criteria

  • Have received treatment for AML, including growth factors, within three weeks before the study, except for hydroxyurea for high white blood cell counts.
  • Have acute promyelocytic leukemia (APL).
  • Have had radiotherapy within four weeks before the study.
  • Have not recovered from side effects of previous treatments to less than grade 1.
  • Have taken valproic acid within two weeks before the study.
  • Have allergies to study drugs or their components.
  • Have advanced liver cancer.
  • Have used demethylating agents for leukemia in the last four months.
  • Have serious or uncontrolled medical conditions.
  • Are using other investigational drugs.
  • Are HIV-positive.
  • Are pregnant or breastfeeding.
  • Do not agree to use effective birth control during the study and for 30 days after treatment.

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