Phase II Study of Epirubicin and Rituximab in Relapsed and Refractory B-Cell Non-Hodgkin's Lymphoma and CLL

Inclusion Criteria

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