Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

Not Recruiting

Trial ID: NCT00658814


This phase II trial is studying the side effects of giving azacitidine together with gemtuzumab ozogamicin to see how well it works in treating older patients with previously untreated acute myeloid leukemia. 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. Azacitidine may also 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. Giving azacitidine together with gemtuzumab ozogamicin may kill more cancer cells.

Official Title

A Phase II Trial of Azacitidine (NSC-102816) Plus Gemtuzumab Ozogamicin (NSC-720568) as Induction and Post-Remission Therapy in Patients of Age 60 and Older With Previously Untreated Non-M3 Acute Myeloid Leukemia

Stanford Investigator(s)

Caroline Berube
Caroline Berube

Clinical Associate Professor, Medicine - Hematology

Jason Gotlib

Professor of Medicine (Hematology)


Inclusion Criteria:

   - Morphologically confirmed diagnosis of acute myeloid leukemia (AML) with
   classification other than WHO acute promyelocytic leukemia (FAB M3), based on bone
   marrow examination performed within 14 days prior to registration; patients with World
   Health Organization (WHO) acute promyelocytic leukemia (FAB M3) or blastic
   transformation of chronic myelogenous leukemia are not eligible

   - Zubrod performance status 0-3

   - No known hypersensitivity to azacitidine, mannitol, hydroxyurea, orgemtuzumab

   - No prior systemic chemotherapy for acute leukemia with the exception of hydroxyurea;
   administration of hydroxyurea to control high white blood cell (WBC) count prior to
   registration is permitted

   - Patients with a history of prior myelodysplastic syndrome (MDS) are eligible according
   to the following criteria:

      - No prior treatment of MDS with AML induction-type chemotherapy or high-dose
      chemotherapy with hematopoietic stem cell support

      - Prior cytarabine allowed if dose < 100 mg/m^2/day

      - Prior hematopoietic growth factors, thalidomide, lenalidomide, arsenic trioxide,
      and signal transduction inhibitors for treatment of MDS allowed

      - No prior treatment with azacitidine, decitabine, or gemtuzumab ozogamicin

      - At least 30 days since prior therapy for MDS and recovered

   - Bilirubin =< 2.0 x institutional upper limit of normal (IULN) within 14 days to
   registration, unless the elevation is believed to be due to hepatic infiltration by

      - Hyperbilirubinemia due primarily to elevated unconjugated hyperbilirubinemia
      secondary to Gilbert syndrome or hemolysis is allowed

   - Serum glutamic oxaloacetic transaminase (SGOT) aspartate aminotransferase (AST) =< 2 x
   IULN, or serum glutamic pyruvate transaminase (SGPT) alanine aminotransferase (ALT) =<
   2.0 x IULN , unless the elevation is believed to be due to hepatic infiltration by AML

   - Serum creatinine =< 1.5 x IULN

   - Left ventricle ejection fraction (LVEF) >= 40% by multi-gated acquisition scan (MUGA)
   or echocardiogram (ECHO) AND no clinical evidence of congestive heart failure within
   the past 56 days

   - Pretreatment cytogenetics must be performed on all patients; collection of
   pretreatment specimens must be completed within 14 days prior to registration to
   S0703; specimens must be submitted to the site's preferred cytogenetics laboratory

   - Patients must consent to submit specimens to the Southwest Oncology Group (SWOG) acute
   lymphoblastic leukemia (ALL)/chronic lymphocytic leukemia (CLL)/chronic myelogenous
   leukemia (CML) repository for cellular and molecular studies; collection of
   pretreatment blood and/or marrow specimens must be completed within 14 days prior to
   registration; if a marrow specimen is available, either from the diagnostic marrow or
   a repeat pre-registration marrow, then it must be submitted along with a peripheral
   blood specimen; otherwise peripheral blood alone must be submitted; residual specimens
   will only be banked if the patient provides separate consent; sites are required to
   offer patients the opportunity to participate in banking

   - No central nervous system (CNS) involvement; if central nervous involvement is
   clinically suspected, it must be ruled out by a lumbar puncture

   - Women of reproductive potential must have a pregnancy test within 28 days prior to
   registration; patients must not be pregnant or nursing because of the teratogenic
   potential of the drugs used in this study; women/men of reproductive potential must
   have agreed to use an effective contraceptive method

   - Patients not known to be human immunodeficiency virus positive (HIV+) must be tested
   for HIV infection within 14 days prior to registration

   - HIV-positive patients must meet the following criteria:

      - No history of acquired immunodeficiency syndrome (AIDS)-defining events

      - CD4 cells >= 500/mm^3

      - Viral load of < 50 copies HIV messenger ribonucleic acid (mRNA)/mm^3 if on cART
      or < 25,000 copies HIV mRNA if not on cART

      - No zidovudine or stavudine as part of cART Patients who are HIV+ and do not meet
      all of these criteria will not be eligible for this study

   - No other prior malignancy except for a) adequately treated basal cell or squamous cell
   skin cancer or b) any diagnosis of malignancy made within the past 2 years earlier, of
   which there is no clinically evident cancer, and for which the patient has completed
   all chemotherapy and radiotherapy at least 6 months prior to study registration; prior
   treatment with AML induction-type chemotherapy is not allowed; concurrent hormonal
   therapy is allowed

   - All patients must be informed of the investigational nature of this study and must
   sign and give written informed consent in accordance with institutional and federal

   - At the time of patient registration, the treating institution's name and
   identification (ID) number must be provided to the Data Operations Center in Seattle
   in order to ensure that the current (within 365 days) date of institutional review
   board approval for this study has been entered into the data base

   - Patients must have complete remission (CR) or CRi, documented by blood and marrow
   examinations performed within 42 days before this registration

   - Following completion of induction therapy, the blood counts must recover to absolute
   neutrophil count (ANC) >= 1,000/mcL and platelets >= 90,000/mcL (without transfusion),
   and must be maintained at these levels during the 7 days prior to registration

   - Patients must have serum creatinine =< 1.5 x IULN and SGOT or SGPT =< 1.5 x IULN
   within 28 days before registration

   - Patients must have recovered to =< Grade 2 from any induction cycle non-hematologic


drug: azacitidine

drug: gemtuzumab ozogamicin

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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