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

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Drugs used in chemotherapy such as epirubicin use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining epirubicin with rituximab may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining epirubicin with rituximab in treating patients who have relapsed or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Leukemia, Lymphoma

Intervention / Treatment
-----------------
* Biological: rituximab
* Drug: epirubicin hydrochloride


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: rituximab|nan|
|Drug: epirubicin hydrochloride|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
B-cell chronic lymphocytic leukemia, refractory chronic lymphocytic leukemia, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma