S0521, Combination Chemotherapy With or Without Gemtuzumab Followed By Tretinoin, Mercaptopurine, and Methotrexate or Observation in Treating Patients With Acute Promyelocytic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Promyelocytic, Acute
Intervention: mercaptopurine; methotrexate; tretinoin
Intervention description: Given orally; Given orally; Given orally
Intervention MeSH terms: Methotrexate; Mercaptopurine; Tretinoin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adult acute myeloid leukemia with t(15;17)(q22;q12); adult acute promyelocytic leukemia (M3); untreated adult acute myeloid leukemia

Summary:

      RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer
      cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,
      such as gemtuzumab, 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. Sometimes the cancer may not need more treatment until it
      progresses. In this case, observation may be sufficient. It is not yet known whether
      combination chemotherapy is more effective than observation when given as maintenance therapy
      in treating acute promyelocytic leukemia.

      PURPOSE: This randomized phase III trial is studying tretinoin, mercaptopurine, and
      methotrexate to see how well they work when given as maintenance therapy compared with
      observation after combination chemotherapy in treating patients with acute promyelocytic
      leukemia. (Randomization and observation group closed as of 8/15/10)
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Cytologically confirmed acute promyelocytic leukemia (APL) or the variant form of APL

               -  Previously untreated disease

               -  Low- or intermediate-risk disease

                    -  Low-risk disease, defined as white blood cell (WBC) ≤ 10,000/mm^3 and
                       platelet count > 40,000/mm^3

                    -  Intermediate-risk disease, defined as WBC ≤ 10,000/mm^3 and platelet count ≤
                       40,000/mm^3

                    -  WBC and platelet count confirming low- or intermediate-risk disease must be
                       obtained within 48 hours prior to study registration unless the patient
                       received tretinoin therapy prior to study registration in which case the WBC
                       and platelet count must be obtained within 48 hours prior to study therapy

          -  PML-RARα fusion gene positive by reverse transcriptase-polymerase chain reaction
             (RT-PCR) assay

          -  No recurrent disease

          -  Must be registered on clinical trials SWOG-9007 and SWOG-S9910

               -  Specimens must be collected prior to tretinoin therapy and may be collected after
                  tretinoin therapy

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status 0-3

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception for ≥ 1 month prior to, during, and
             for 2 months after completion of study treatment

          -  No unstable cardiac arrhythmia or unstable angina

          -  No other malignancy within the past 5 years except for the following:

               -  Adequately treated basal cell or squamous cell skin cancer

               -  Carcinoma in situ of the cervix

               -  Adequately treated stage I or II cancer (except for highly aggressive
                  malignancies with a high rate of early relapse) currently in complete remission

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No more than 1 prior dose of intrathecal chemotherapy for acute leukemia

          -  No prior systemic chemotherapy, hydroxyurea, or leukapheresis for acute leukemia

               -  Prior tretinoin at a dose of ≤ 45 mg/m^2/day allowed provided it was received ≤ 5
                  days prior to study registration