Optimized Donor Selection, Nonmyeloablative BMT for B-cell Lymphomas With Post-transplantation Cy and Rituximab
|ClinicalTrials.gov Identifier: NCT00946023|
Recruitment Status : Terminated
First Posted : July 24, 2009
Last Update Posted : September 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma B-cell Lymphoma Non Hodgkin Lymphoma Chronic Lymphocytic Leukemia||Drug: Bone marrow transplantation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||135 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nonmyeloablative BMT With Post-transplant Cyclophosphamide, Rituximab and Optimized Donor Selection for B-cell Lymphomas|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||July 2013|
|Estimated Study Completion Date :||August 2015|
Drug: Bone marrow transplantation
Nonmyeloablative conditioning regimen: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1-2 hours on days -6 and -5. Patients undergo total body irradiation on day -1.
Allogeneic bone marrow transplantation: Patients undergo donor bone marrow infusion on day 0.
Post-transplantation therapy: Patients receive cyclophosphamide IV over 1-2 hours on days 3 and 4. Beginning day 30, rituximab IV is administered once per week for 8 weeks.
Graft-vs-host disease prophylaxis: Beginning on day 5, patients receive oral mycophenolate mofetil until day 35 and tacrolimus (IV then changing to orally) until day 180.
- Event-free survival [ Time Frame: one year ]
- Longer-term event-free survival, overall survival, relapse, nonrelapse mortality, and incidence of acute and chronic graft versus host disease [ Time Frame: day 100, 1 year, 3 years ]
- Feasibility of selecting donors based on favorable Fc receptor polymorphism status [ Time Frame: four years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946023
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||Yvette L Kasamon, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|