High-Dose Y-90-Ibritumomab Tiuxetan Added to Reduced-Intensity Allogeneic Stem Cell Transplant Regimen for Relapsed or Refractory Aggressive B-Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT01434472|
Recruitment Status : Recruiting
First Posted : September 15, 2011
Last Update Posted : July 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Post-Transplant Lymphoproliferative Disorder Recurrent Adult Diffuse Large Cell Lymphoma Recurrent B-Cell Non-Hodgkin Lymphoma Recurrent Burkitt Lymphoma Refractory B-Cell Non-Hodgkin Lymphoma Refractory Burkitt Lymphoma Refractory Diffuse Large B-Cell Lymphoma||Procedure: Allogeneic Hematopoietic Stem Cell Transplantation Drug: Cyclosporine Drug: Fludarabine Phosphate Radiation: Indium In-111 Ibritumomab Tiuxetan Drug: Mycophenolate Mofetil Other: Pharmacological Study Biological: Rituximab Radiation: Total-Body Irradiation Radiation: Yttrium Y-90 Ibritumomab Tiuxetan||Phase 2|
I. To assess the safety and efficacy of 1.5 mCi/kg (max 120 mCi) 90Y-Ibritumomab tiuxetan (yttrium Y 90 ibritumomab tiuxetan) (anti-CD20) combined with fludarabine (fludarabine phosphate) (30 mg/m^2 x 3) and 2 gray (Gy) total body irradiation followed by human leukocyte antigens (HLA) matched allogeneic hematopoietic transplantation for patients with relapsed or refractory aggressive B-cell lymphoma.
Beginning 24-48 hours prior to therapy infusion, patients receive rituximab intravenously (IV) over 4-6 hours and then receive a therapy-dose of high-dose yttrium Y 90 ibritumomab tiuxetan IV over 30 minutes on day -14 prior to transplant. Patients also receive fludarabine phosphate IV on days -4 to -2 and undergo TBI followed by allogeneic PBSCT on day 0. Patients also receive cyclosporine orally (PO) twice daily (BID) on days -3 to 56 with taper to day 180 (related donor) or -3 to 100 with taper over 11 weeks (unrelated donor) and mycophenolate mofetil PO BID on days 0-27 (related donor) or PO thrice daily (TID) on days 0-40 with taper to day 96 (unrelated donor).
After completion of study treatment and assessments through ~day 100 following transplant, patients are followed up at 1, 3, 6, and 12 months and then annually thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of High-Dose 90Y-Ibritumomab Tiuxetan (Anti-CD20) Followed by Fludarabine and Low-Dose Total Body Irradiation and HLA-Matched Allogeneic Hematopoietic Transplantation for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma|
|Actual Study Start Date :||November 16, 2011|
|Estimated Primary Completion Date :||September 24, 2019|
|Estimated Study Completion Date :||September 24, 2022|
Experimental: Treatment (radiolabeled antibody, TBI, allogeneic PBSCT)
Beginning 24-48 hours prior to therapy infusion, patients receive rituximab IV over 4-6 hours and then receive a therapy-dose of high-dose yttrium Y 90 ibritumomab tiuxetan IV over 30 minutes on day -14 prior to transplant. Patients also receive fludarabine phosphate IV on days -4 to -2 and undergo TBI followed by allogeneic PBSCT on day 0. Patients also receive cyclosporine PO BID on days -3 to 56 with taper to day 180 (related donor) or -3 to 100 with taper over 11 weeks (unrelated donor) and mycophenolate mofetil PO BID on days 0-27 (related donor) or PO TID on days 0-40 with taper to day 96 (unrelated donor).
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Undergo allogeneic PBSCT (infusion of donor stem cells via central catheter)
Drug: Fludarabine Phosphate
Radiation: Indium In-111 Ibritumomab Tiuxetan
Drug: Mycophenolate Mofetil
Other: Pharmacological Study
Given IV prior to yttrium Y 90 ibritumomab tiuxetan
Radiation: Total-Body Irradiation
Radiation: Yttrium Y-90 Ibritumomab Tiuxetan
- Progression-free survival [ Time Frame: 1 year ]Based on a one-sample chi-square test with one-sided significance level of five percent. This study will be deemed successful if the 1 year progression-free survival of this highest-risk group of patients is 54% or greater.
- Engraftment and hematopoietic toxicity [ Time Frame: Up to day 100 ]Toxicity graded in severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.
- Overall survival [ Time Frame: Up to 4 years ]
- Response rates [ Time Frame: Day 100 ]
- Treatment-related mortality [ Time Frame: Day 100 ]Defined as death in the absence of progressive lymphoma that can be possibly, probably, or definitely attributed to the radioimmunotherapy.
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): NCT01434472
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Ajay K. Gopal 206-288-2037 firstname.lastname@example.org|
|Principal Investigator: Ajay K. Gopal|
|Principal Investigator:||Ajay Gopal||Fred Hutch/University of Washington Cancer Consortium|