Epirubicin and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

OBJECTIVES:

• Determine the response rate, time to progression, and overall survival of patients with refractory or relapsed B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia treated with epirubicin and rituximab.
• Determine the toxicity of this regimen in these patients.
• Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a non-randomized, open-label, multicenter study.

Patients receive epirubicin IV over 3-5 minutes once weekly for 6 weeks. Patients also receive rituximab IV on weeks 2 and 5 during course 1 and then on weeks 1 and 4 for all remaining courses. Treatment repeats every 8 weeks for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression.

PROJECTED ACCRUAL: A total of 18-38 patients will be accrued for this study within 2.5-3 years.

DISEASE CHARACTERISTICS:

• Histologically confirmed B-cell non-Hodgkin's lymphoma (any grade) or chronic lymphocytic leukemia meeting 1 of the following criteria:

• Primary refractory disease
• Disease progression after at least 1 but no more than 4 prior cytotoxic chemotherapy regimens

• Rituximab administered alone is not considered 1 prior regimen
• High-dose chemotherapy with stem cell support is considered 1 prior regimen
• Bidimensionally measurable or evaluable disease outside prior irradiation port
• No clinical evidence of CNS involvement

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Neutrophil count at least 2,000/mm^3*
• Platelet count at least 100,000/mm^3* NOTE: *Unless due to bone marrow involvement

Hepatic

• Bilirubin no greater than 1.5 mg/dL
• SGOT and SGPT no greater than 2 times upper limit of normal (ULN)

Renal

• Creatinine no greater than 2 times ULN

Cardiovascular

• No unstable angina
• No uncontrolled congestive heart failure
• LVEF at least 45%

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after study treatment
• HIV negative
• No other concurrent primary malignancy except basal cell or squamous cell skin cancer, carcinoma in situ, or localized solid tumors cured more than 5 years ago
• No acute infection requiring systemic therapy
• No confusion, disorientation, or major psychiatric illness that would preclude understanding of informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics
• At least 4 weeks since prior biologic therapy

Chemotherapy

• See Disease Characteristics
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
• Prior cumulative doxorubicin dose no greater than 6 courses at 50 mg/m^2

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• No prior radiotherapy to the entire pelvis
• At least 4 weeks since prior radiotherapy

Surgery

• Not specified

Other

• More than 7 days since prior cimetidine
• No concurrent cimetidine