Interferon-alfa With or Without Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia
Condition: Leukemia
MeSH terms: Leukemia
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Drugs used in
      chemotherapy use different ways to stop cancer cells from dividing so they stop growing or
      die. Combining interferon alfa with high-dose chemotherapy and peripheral stem cell
      transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more
      cancer cells.

      PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or
      without peripheral stem cell transplantation in treating patients who have newly diagnosed
      chronic myelogenous leukemia in chronic phase.
    

Detailed description: 
      OBJECTIVES: I. Compare overall survival in patients with chronic myelogenous leukemia in
      chronic phase treated with interferon alfa with or without cytarabine vs autologous
      peripheral blood stem cell transplantation followed by interferon alfa with or without
      cytarabine. II. Compare the time to blast transformation with these treatment regimens in
      these patients. III. Compare the number of these patients reverting to Philadelphia
      chromosome (Ph) negative hematopoiesis with these treatment regimens. IV. Compare the
      complete and major cytogenetic response rates in these patients at one year after receiving
      these treatment regimens and annually thereafter. V. Compare the hematological remission rate
      in these patients after receiving these treatment regimens. VI. Compare the duration of
      hematological remission and its impact on survival and blastic transformation in these
      patients after receiving these treatment regimens. VII. Compare the duration of Ph negative
      hemapoiesis and its impact on survival and blastic transformation in these patients after
      receiving these treatment regimens. VIII. Determine the number of these patients who fail one
      treatment regimen and can be rescued with the alternative. IX. Compare quality of life in
      these patients with these treatment regimens. X. Determine the number of these patients who
      tolerate these two regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
      treatment arms. Arm I: Patients undergo mobilization chemotherapy with a regimen of the
      center's choice, such as either of the following: Patients receive idarubicin IV over 10
      minutes, etoposide IV over 2 hours, and cytarabine IV over 2 hours on days 1-3; and
      filgrastim (G-CSF) subcutaneously (SC) starting day 11 and continuing until blood counts
      recover. OR Patients receive hydroxyurea IV daily until the neutrophil count drops below
      1,000/mm3 or the platelet count drops below 20,000/mm3 followed by G-CSF SC for 3 consecutive
      days or until leukapheresis is complete. Following mobilization therapy, patients undergo
      leukapheresis within 6 months of diagnosis. Patients then undergo cytoreductive therapy
      consisting of oral busulfan on days -5 to -2. Autologous peripheral blood stem cells are
      infused on day 0. Once blood counts have recovered, patients receive interferon alfa SC 3
      times a week for 8 weeks, and then daily for at least a total of 6 months or until disease
      progression. At the discretion of the treating physician, patients may also receive
      cytarabine SC once a day for 10 days each month, beginning 2 weeks after the interferon alfa
      therapy begins and continuing until complete cytogenetic response is achieved. Arm II:
      Patients receive interferon alfa SC 3 times a week for 4 weeks, and then daily for 6 months.
      If hematological remission is achieved after 6 months, interferon treatment is continued for
      at least another 6 months or until disease progression. At the discretion of the treating
      physician, patients may also receive cytarabine as in arm I. Quality of life is assessed at
      defined intervals. Patients are followed for at least 2 years.

      PROJECTED ACCRUAL: Approximately 744 patients will be accrued for this study within 5 years.
    

Intervention name(s): filgrastim; recombinant interferon alfa; busulfan; cytarabine; etoposide; hydroxyurea; idarubicin; peripheral blood stem cell transplantation
Intervention type(s): Biological; Biological; Drug; Drug; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Interferons; Cytarabine; Interferon-alpha; Etoposide; Idarubicin; Busulfan; Hydroxyurea
Allocation: Randomized
Primary purpose: Treatment
Keywords: chronic phase chronic myelogenous leukemia