A Randomized Phase II Trial of Azacitidine With or Without the Histone Deacetylase Inhibitor Entinostat for the Treatment of Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (Dysplastic Type), and Acute Myeloid Leukemia With Multilineage Dysplasia

This randomized phase II trial is studying azacitidine and entinostat to see how well they work compared to azacitidine alone in treating patients with myelodysplastic syndromes, chronic myelomonocytic leukemia, or acute myeloid leukemia. Both treatment-induced and non-treatment-induced cohorts are allowed. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Entinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine together with entinostat may kill more cancer cells.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : entinostat
  • drug : azacitidine

Phase: Phase 2

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Bone marrow aspirate and/or biopsy-confirmed diagnosis of 1 of the following: - Myelodysplastic syndromes (MDS) - Any International Prognostic Score (IPSS) eligible - Patients with low or intermediate-1 IPSS must have platelet count < 50,000/mm≥ and/or absolute neutrophil count < 500/mm≥ - Blast count < 20% - Chronic myelomonocytic leukemia (CMMoL; dysplastic subtype) - White blood cells (WBC) < 12,000/mm≥ (measured twice within the past 4 weeks, 2 weeks apart) - Acute myeloid leukemia with multilineage dysplasia (AML-TLD) - Formerly diagnosed refractory anemia with excess blasts in transformation by French-American-British (FAB) criteria allowed - AML-TLD by World Health Organization (WHO) criteria allowed in patients with no history of antecedent hematologic disorder - WBC ? 30,000/mm≥ (measured twice within the past 4 weeks, 2 weeks apart) - WBC that has doubled over 4 weeks and > 20,000/mm≥ is not eligible - Evidence of ? 20% blasts on review of the bone marrow aspirate and/or biopsy - Therapy-induced MDS, AML-TLD, or chronic myelomonocytic leukemia (dysplastic subtype) allowed - Age ? 18 years. - Negative pregnancy test - Fertile patients must use effective contraception - ECOG performance status 0-2 - Creatinine < 2.0 mg/dL - Bilirubin normal (unless due to intramedullary or extramedullary hemolysis, or Gilbert's syndrome) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2.5 times upper limit of normal - Life expectancy ? 6 months - SWOG (Southwest Oncology Group) patients must be enrolled in research study trial SWOG-9007

External Links

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Contact information

Primary Contact:

Mai Tran 6507238594

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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