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Vorinostat + Gemtuzumab Ozogamicin/Azacitidine for AML (FHCRC-2288)
A Phase 1/2 Study of Vorinostat (Zolinza®) in Combination with Gemtuzumab Ozogamicin (Mylotarg®) and Azacitidine (Vidaza®) in Patients 50 Years of Age and Older with Relapsed/Refractory non-APL Acute Myeloid Leukemia (AML)
Status Conditions Phase Study ID
Closed Acute Myeloid Leukemia (AML) Phase I/II FHCRC-2288

RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. 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. Giving vorinostat together with gemtuzumab ozogamicin and azacitidine may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of vorinostat and to see how well it works when given together with gemtuzumab ozogamicin and azacitidine in treating older patients with relapsed or refractory acute myeloid leukemia (AML).

Roland Walter, MD
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Morphological diagnosis of acute myeloid leukemia (AML)

    • No acute promyelocytic leukemia (FAB M3)
    • Biphenotypic AML allowed
  • Must have cytogenetic analysis performed on bone marrow specimen within 14 days prior to study entry unless undergoing cytoreduction with hydroxyurea for WBC ≥ 25,000/μL
  • Requires first salvage chemotherapy for persistent or relapsing disease after ≥ 1 course of conventional chemotherapy (e.g., with "7+3"), as defined by persistence of ≥ 50% myeloid blasts measured on 1 occasion or persistence of ≥ 20% myeloid blasts measured on 2 occasions with no improvement between first and second assessments performed 3-7 days apart

    • Duration of first complete remission < 12 months OR primary resistant disease
    • Not in remission
    • No second or subsequent relapse
  • No refractory/relapsing chronic myelogenous leukemia in blast crisis
  • No clinical evidence suggestive of CNS involvement with leukemia unless a lumbar puncture confirms the absence of leukemic blasts in the cerebrospinal fluid
Last Updated
December 21, 2012
See this trial at
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.