This phase II trial studies how well ibritumomab tiuxetan before donor peripheral blood stem cell transplant works in treating patients with relapsed or refractory non-Hodgkin lymphoma. Giving rituximab, antithymocyte globulin, and total-lymphoid irradiation (TLI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. Also, radiolabeled monoclonal antibodies, such as ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving rituximab, antithymocyte globulin, and TLI before the transplant together with cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. Giving a radiolabeled monoclonal antibody before a donor peripheral blood stem cell transplant may be an effective treatment for non-Hodgkin lymphoma.
PRIMARY OBJECTIVES: I. To measure the response conversion (progressive disease \[PD\]/stable disease \[SD\] to partial response \[PR\] and complete response \[CR\]). SECONDARY OBJECTIVES: I. To assess the time to engraftment/chimerism. II. To assess the rate of acute and chronic graft-versus-host disease (GVHD). III. To assess toxicity. IV. To determine the overall survival. V. To investigate immune functional and phenotypic analysis. VI. To measure two year event free survival (EFS). OUTLINE: CONDITIONING REGIMEN: Patients receive rituximab intravenously (IV) on days -21 and 14, ibritumomab tiuxetan IV on day -14, TLI on days -11 to -7 and -4 to -1, and antithymocyte globulin IV over 4-6 hours on days -11 to -7. Patients also undergo TLI on days -11 to -7 and -4 to -1. TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant (PBSCT) on day 0. GVHD PROPHYLAXIS: Patients receive cyclosporine orally (PO) twice daily (BID) or IV on days -3 to 56 with taper to 6 months and mycophenolate mofetil PO BID or IV on days 0-28. After completion of study treatment, patients are followed up periodically.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Given IV
Given IV
Given IV
Undergo TLI
Undergo allogeneic peripheral blood stem cell transplant
Undergo allogeneic peripheral blood stem cell transplant
Given PO or IV
Given PO or IV
University of California Davis
Sacramento, California, United States
Response conversion rate (PD/SD to PR and CR)
Calculated along with 95% confidence intervals (CI). Logistic regression will be used to assess the impact of patient characteristics (e.g., low/high lactate dehydrogenase isoenzyme-3 \[LDH\] or immunologic correlates) on the response conversion rate.
Time frame: Up to 60 days post-transplant
Time to engraftment/chimerism
Estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups of patients will be made using the logrank test. Cox (proportional hazards) regression will be used to evaluate multivariable predictive models of time-to-event outcomes when proper.
Time frame: Up to 3 years
Rate of acute GVHD
Time frame: Up to day 730
Rate of chronic GVHD
Time frame: Up to day 730
Overall survival
Estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups of patients will be made using the logrank test. Cox (proportional hazards) regression will be used to evaluate multivariable predictive models of time-to-event outcomes when proper.
Time frame: Up to day 730
EFS
Comparison of time-to-event endpoints by important subgroups of patients will be made using the logrank test. Cox (proportional hazards) regression will be used to evaluate multivariable predictive models of time-to-event outcomes when proper.
Time frame: 2 years
Toxicities
Toxicities as measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v4.0
Time frame: Up to day 730
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