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

Primary Purpose

Leukemia, Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
rituximab
epirubicin hydrochloride
Sponsored by
Fox Chase Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fox Chase Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 5, 2003
Last Updated
July 10, 2013
Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00062296
Brief Title
Epirubicin and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Official Title
Phase II Study of Epirubicin and Rituximab in Relapsed and Refractory B-Cell Non-Hodgkin's Lymphoma and CLL
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Type
Drug
Intervention Name(s)
epirubicin hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell R. Smith, MD, PhD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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