CompletedPhase 2

Comparison of Three Treatment Regimens in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia

United StatesStarted 2000-10-04

Plain-language summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining more than one drug or combining monoclonal antibody with chemotherapy may kill more cancer cells. It is not yet known which treatment regimen is more effective for acute myelogenous leukemia. PURPOSE: Randomized phase II trial to compare the effectiveness of three treatment regimens in treating patients who have relapsed or refractory acute myelogenous leukemia.

Who can participate

Age range18 Years – 120 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Histologically proven acute myelogenous leukemia of one of the following types: * Acute myeloblastic leukemia (FAB type M0, M1, or M2) * Acute promyelocytic leukemia (FAB type M3) allowed if ineligible for an ECOG M3 protocol or if no tretinoin or arsenic trioxide therapy is planned * Acute myelomonocytic leukemia (FAB type M4) * Acute monocytic leukemia (FAB type M5) * Acute erythroleukemia (FAB type M6) * Acute megakaryocytic leukemia (FAB type M7) * Must meet 1 of the following criteria: * Relapse less than 6 months after first complete remission (CR) * Relapse 6-12 months after first CR * Refractory to conventional initial induction chemotherapy (no more than 2 courses) or first reinduction (no more than 1 course) * Must have marrow documentation of residual leukemia after chemotherapy (for at least 2 weeks duration) * Second or greater relapse * No relapse greater than 1 year after achieving first CR * Blast cells must be CD33 positive * Prior CNS leukemia allowed if there is currently documentation of no CNS involvement on CSF examination (i.e., negative CSF by lumbar puncture) PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * Bilirubin no greater than 2.0 mg/dL\* * SGOT less than 2 times upper limit of normal\* NOTE: \*Unless due to leukemia infiltration Renal: * Creatinine no greater than …

Trial details

NCT IDNCT00005962

SponsorEastern Cooperative Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2005-10