This phase 2 clinical trial will test the safety and effectiveness of yttrium-90 (Y-90)-ibritumomab tiuxetan (Zevalin) followed by fludarabine(Fludara), total body irradiation, and donor peripheral blood stem cell transplant (PBSCT) in patients with relapsed or refractory (did not respond to treatment) B-cell lymphoma. The primary outcome will be measured by the time until the disease progresses. This trial is being conducted at the University of Washington Cancer Consortium.
Relapsed or refractory B-cell lymphoma is cancer that either has come back after a period of improvement or is unresponsive to treatment. Systemic therapy followed by a stem cell transplant may help improve the disease. Y-90-ibritumomab is a radioimmunotherapy. This treatment uses antibodies (a protein in the immune system) to deliver radiation directly to cancerous B-cells. Fludarabine is a chemotherapy used for treating lymphoma and may help prevent rejection of transplanted stem cells. Before a blood stem cell transplant, total body irradiation (a form of radiotherapy) is necessary to suppress the recipient’s immune system, so the new cells can be accepted. PBSCT is a nonsurgical stem cell transplant procedure that provides the recipient with healthy blood stem cells.
This study will examine the effectiveness of this combined treatment in patients with relapsed or refractory B-cell lymphoma. The study will examine the time until the disease progresses up to 1 year, side effects, response rate, and overall survival.
Who are they looking for?
This trial is recruiting 24 patients with relapsed or refractory aggressive B-cell lymphoma, expressing the CD20 antigen. Patients must have failed at least one systemic therapy. Patients must have relapsed after or be ineligible for high-dose therapy and transplantation (due to chemotherapy resistance). Participants must also have a matched stem cell donor. Participants must have normal or near normal liver function.
Ideal candidates should not have received intravenous (IV) chemotherapy or antibody agents 30 days prior to the study (100 days if high-dose chemotherapy or radiotherapy). Other anticancer agents must have undergone at least 5 half-lives prior to entry. Male and female patients must agree to use contraception for up to 12 months after treatment.
How will it work
Patients will first receive rituximab (Rituxan) intravenously (through IV) for 4-6 hours. Rituximab is an immunotherapy that uses the body’s own immune system to identify and kill B-cells. Patients will then receive Y-90-ibritumomab tiuxetan intravenously for 30 minutes on day -14 prior to transplant. Fludarabine will be administered intravenously on days -4 to -2 before transplant. Total body irradiation and PBSCT will occur on day 0. Following the procedure, patients will be temporarily placed on oral immunosuppressant drugs (treatments to block the immune system).