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

Phase 2
18 Years
Not Enrolling
Leukemia, Lymphoma

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Trial Information

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


- 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

Inclusion Criteria


- 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



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified


- Neutrophil count at least 2,000/mm^3*

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


- Bilirubin no greater than 1.5 mg/dL

- SGOT and SGPT no greater than 2 times upper limit of normal (ULN)


- Creatinine no greater than 2 times ULN


- No unstable angina

- No uncontrolled congestive heart failure

- LVEF at least 45%


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study

- 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


Biologic therapy

- See Disease Characteristics

- At least 4 weeks since prior biologic therapy


- 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


- See Disease Characteristics

- No prior radiotherapy to the entire pelvis

- At least 4 weeks since prior radiotherapy


- Not specified


- More than 7 days since prior cimetidine

- No concurrent cimetidine

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Mitchell R. Smith, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 2003

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • 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
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell



Fox Chase Cancer Center Philadelphia, Pennsylvania  19111