Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia or Acute Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to
      give higher doses of chemotherapy drugs and kill more cancer cells.

      PURPOSE: Clinical trial to study the effectiveness of combination chemotherapy plus
      peripheral stem cell transplantation in treating patients who have chronic myelogenous
      leukemia or acute leukemia.
    

Detailed description: 
      OBJECTIVES: I. Determine safety and toxicity of induction and transplant regimens in patients
      with chronic myelogenous leukemia or high-risk acute leukemia. II. Determine efficacy of
      collecting peripheral blood stem cells (PBSC) during early hematopoietic recovery from
      intensive chemotherapy as a means for in vivo enrichment for cytogenetically normal
      progenitor cells in this patient population. III. Correlate cytogenetic and molecular
      responses in the peripheral blood and bone marrow with clinical response, time to
      progression, and survival in these patients at several timepoints before and after
      myelosuppressive and myeloablative therapy.

      OUTLINE: This is a multicenter study. Patients are stratified according to disease (chronic
      myelogenous leukemia vs acute lymphoblastic leukemia vs acute myelogenous leukemia). Patients
      receive cytarabine IV over 4 hours, etoposide IV over 1.5-2 hours, and idarubicin IV over
      5-10 minutes on days 1, 3, and 5. Filgrastim (G-CSF) is administered subcutaneously (SC)
      daily beginning on day 2 and continuing until blood counts recover. Chronic myelogenous
      leukemia: On day 14 following chemotherapy, if bone marrow biopsy shows less than 20%
      cellularity and a peripheral blood sample contains greater than 50% cytogenetically normal
      cells, patients receive a second induction course followed by apheresis. Patients with less
      than 50% cytogenetically normal cells are also considered for a second induction course.
      Patients with no response or progressive disease are removed from the study. Acute leukemia:
      On day 14 following chemotherapy, if bone marrow biopsy shows less than 20% cellularity and
      the peripheral blood sample shows 100% cytogenetically normal cells, patients receive a
      second induction course followed by apheresis. Patients with high risk disease in first
      remission at time of study entry undergo apheresis during recovery from first course of
      induction therapy and second course may be omitted. Patients receive second induction course
      followed by G-CSF as after first induction course. Once blood counts recover, patients
      undergo harvest of peripheral blood stem cells (PBSC). Patients also undergo bone marrow stem
      cell collection in case of failure of PBSC transplantation (PBSCT). Patients receive the
      following conditioning regimen: total body irradiation twice a day on days -8 to -5;
      etoposide IV over 4 hours on day -4; and cyclophosphamide IV over 2 hours on day -2. PBSCT is
      conducted on day 0. G-CSF SC is administered beginning on day 1 and continues until blood
      counts recover. Patients receive maintenance therapy with interferon alfa SC 3 times a week
      for 12 months. Patients are followed weekly for 3 months and then monthly until death.

      PROJECTED ACCRUAL: Approximately 15 patients will be accrued for this study.
    

Intervention name(s): filgrastim; recombinant interferon alfa; cyclophosphamide; cytarabine; etoposide; idarubicin; peripheral blood stem cell transplantation; radiation therapy
Intervention type(s): Biological; Biological; Drug; Drug; Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Interferons; Cytarabine; Interferon-alpha; Cyclophosphamide; Etoposide; Idarubicin
Primary purpose: Treatment
Keywords: recurrent adult acute myeloid leukemia; recurrent adult acute lymphoblastic leukemia; relapsing chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia; adult acute myeloid leukemia in remission; adult acute lymphoblastic leukemia in remission