Phase II Trial of Rituximab and Short Duration Chemotherapy Followed by Zevalin as First-Line Treatment for Patients With Low Grade Follicular Non-Hodgkin's Lymphoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Non-Hodgkins Lymphoma
- Sponsor
- SCRI Development Innovations, LLC
- Enrollment
- 40
- Primary Endpoint
- Overall clinical response rate
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
In this trial, we will evaluate the feasibility, toxicity, and effectiveness ibritumomab tiuxetan, when incorporated into combination first-line treatment for follicular lymphoma. Addition of the ibritumomab tiuxetan to our previously evaluated, well tolerated combination of rituximab and short course chemotherapy will allow the use of additional active agent with a unique mechanism of cytotoxicity. In addition, "debulking" of lymphoma prior to 90Y Zevalin administration may minimize the myelotoxicity of this agent.
Detailed Description
Upon determination of eligibility, patients will be receive: * Rituxan + CHOP or CVP + Ibritumomab Tiuxetan Patients who are considered medical candidates for doxorubicin should receive CHOP chemotherapy (Cyclophosphamide, doxorubicin, vincristine and prednisone). Patients who are not considered medical candidates for doxorubicin should receive CVP chemotherapy (Cyclophosphamide, Vincristine, and prednisone)
Investigators
Eligibility Criteria
Inclusion Criteria
- •To be included in this study, you must meet the following criteria:
- •Histologic documentation of follicular center, B-cell lymphoma
- •Early stage lymphoma (stages I or II) relapsed after radiation therapy alone
- •No previous chemotherapy or monoclonal antibody therapy
- •Measurable or evaluable disease
- •Able to perform activities of daily living with minimal assistance
- •Age \> 18 years
- •Adequate bone marrow ,liver and kidney function
- •Must be accessible for treatment and follow-up.
- •Bone marrow examination initial staging and accurate restaging
Exclusion Criteria
- •You cannot participate in this study if any of the following apply to you:
- •Small lymphocytic (CLL type) lymphomas and CLL
- •Impaired bone marrow reserve
- •Female pregnant or lactating
- •Serious active infection at the time of treatment
- •Any other serious underlying condition
- •Central nervous system involvement (brain or meningeal)
- •HIV or AIDS-related lymphoma
- •Received prior external beam radiation therapy to \> 25% of active bone marrow
- •Pleural effusion
Outcomes
Primary Outcomes
Overall clinical response rate
Overall molecular response rate
Secondary Outcomes
- Progression-free survival
- Overall survival
- Overall toxicity