Leukemia Clinical Trial
Official title:
Patients With Chronic Lymphocytic Leukemia or Multiple Myeloma Whose Disease Has Been Controlled With Chemotherapy: Rituximab Anti-CD20 Monoclonal Antibody or Interferon Alpha 2-b as Maintenance Therapy
RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill
them or deliver tumor-killing substances to them without harming normal cells. Biological
therapies such as interferon alfa-2b use different ways to stimulate the immune system and
stop cancer cells from growing.
PURPOSE: Phase II trial to study the effectiveness of rituximab or interferon alfa-2b in
treating patients who have chronic lymphocytic leukemia or multiple myeloma in remission.
OBJECTIVES: I. Determine the toxicity of rituximab or interferon alfa-2b maintenance therapy
in patients with chronic lymphocytic leukemia or multiple myeloma in remission after
chemotherapy. II. Determine the progression free survival, failure free survival, and
overall survival of these patients from time of chemotherapy discontinuation to completion
of maintenance therapy. III. Compare the survival rates of these patients to similar
patients treated in published studies. IV. Determine the quality of life of these patients
on these regimens.
OUTLINE: Patients enter one of two treatment arms: Arm I: Patients receive rituximab IV on
days 1, 8, 15, and 22 for course 1, and then once a month for 11 months or until disease
progression. Arm II: Patients receive subcutaneous interferon alfa-2b every other day three
times per week for 12 months. Quality of life is assessed monthly during therapy. Patients
are followed every 3 months for 1 year, and then annually for up to 5 years.
PROJECTED ACCRUAL: A total of 60-80 patients (30-40 per disease type) will be accrued for
this study.
;
Primary Purpose: Treatment
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