Yttrium Y 90 Ibritumomab Tiuxetan, Fludarabine, Radiation Therapy, and Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00119392|
Recruitment Status : Completed
First Posted : July 13, 2005
Results First Posted : May 24, 2017
Last Update Posted : June 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|B-cell Chronic Lymphocytic Leukemia Nodal Marginal Zone B-cell Lymphoma Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Grade III Lymphomatoid Granulomatosis Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Small Lymphocytic Lymphoma Splenic Marginal Zone Lymphoma Waldenström Macroglobulinemia||Biological: rituximab Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Radiation: yttrium Y 90 ibritumomab tiuxetan Procedure: peripheral blood stem cell transplantation Procedure: allogeneic hematopoietic stem cell transplantation Radiation: total-body irradiation||Phase 2|
I. To assess the feasibility, safety, and potential efficacy of treating patients with B-Cell non-Hodgkin lymphoma (NHL) with 90Y-ibritumomab tiuxetan, combined with HLA-matched related or unrelated donor hematopoietic cell transplantation.
OUTLINE: Patients receive rituximab intravenously (IV) followed by, no more than 4 hours later, indium In 111 ibritumomab tiuxetan (for imaging) IV over 10 minutes on day -21. Patients undergo gamma camera imaging on day -19. Patients receive rituximab IV followed by, no more than 4 hours later, yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14. Patients also receive fludarabine phosphate IV over 30-60 minutes on days -7 to -5 and undergo low-dose total-body irradiation (TBI) on day 0. After TBI, patients undergo allogeneic peripheral blood stem cell transplantation (PBSCT) on day 0. Patients who undergo PBSCT from a related donor receive oral cyclosporine twice daily on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease (GVHD). These patients also receive oral mycophenolate mofetil twice daily on days 0 to 27. Patients who undergo PBSCT from an unrelated donor receive oral cyclosporine twice daily on days -3 to 100 followed by a taper over 11 weeks in the absence of GVHD. These patients also receive oral mycophenolate mofetil three times daily on days 0 to 40 followed by a taper to day 96.
After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months, and then annually thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial Evaluating the Safety and Efficacy of Non-myeloablative 90Y-Ibritumomab Tiuxetan (Anti-CD20) Antibody With Fludarabine, Low-Dose Total Body Irradiation (TBI) and HLA Matched Allogeneic Transplantation for Relapsed B-cell Lymphoma|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||April 23, 2016|
Experimental: Treatment (90Y ibritumomab tiuxetan, hematopoietic transplant)
See Detailed Description
Drug: fludarabine phosphate
Drug: mycophenolate mofetil
Radiation: yttrium Y 90 ibritumomab tiuxetan
Procedure: peripheral blood stem cell transplantation
Procedure: allogeneic hematopoietic stem cell transplantation
Radiation: total-body irradiation
Other Name: TBI
- Treatment Related Mortality (TRM) [ Time Frame: At day +100 ]Cumulative incidence rate of treatment related mortality with relapse as a competing risk, assessed at 30 months.
- Overall and Progression-free Survival [ Time Frame: Up to 8 years ]Kaplan-Meier estimates for overall survival (OS) and progression free survival (PFS) assessed at two years.
- Response Rates [ Time Frame: Up to 8 years ]
- Engraftment and Hematopoietic Toxicity [ Time Frame: At day +100 ]Median number of days after transplantation to a neutrophil count less than 500 neutrophils per microliter and a platelet count less than 50,000 platelets per microliter.
- Incidence and Severity of Acute Graft-versus-host Disease (GVHD) and Chronic GVHD. [ Time Frame: At day +84 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00119392
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Ajay Gopal||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|