NCT00946023

Optimized Donor Selection, Nonmyeloablative BMT for B-cell Lymphomas With Post-transplantation Cy and Rituximab

Nonmyeloablative BMT With Post-transplant Cyclophosphamide, Rituximab and Optimized Donor Selection for B-cell Lymphomas

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 1 Year – 75 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation and rituximab works in treating patients with B-cell lymphoma or chronic lymphocytic leukemia who are undergoing an allogeneic (donor) bone marrow transplant. The type of bone marrow transplant is a less intensive or "mini" transplant using a relative as the bone marrow donor. The donated bone marrow stem cells may replace the patient's immune system cells and help destroy any remaining cancer (graft-versus-tumor effect). Patients undergoing this type of transplant often have more than one relative who could be a donor. The trial is also studying a new way of choosing amongst possible donors which might improve how the rituximab works.

Detailed description

This phase II for relapsed or refractory B-cell malignancies builds on the platform of nonmyeloablative, related-donor, HLA (human leukocyte antigen)-matched or HLA-haploidentical BMT with post-transplantation high-dose cyclosphosphamide administered for prophylaxis of graft-versus-host disease and graft rejection. Rituximab is added to the transplant regimen with the goal of augmenting anti-tumor activity. In patients with B-cell lymphomas, specific polymorphisms in the immunoglobulin Fc receptor have been associated with greater sensitivity to rituximab or rituximab-based therapies, translating in some series into higher response rates and improved progression-free survival. This raises the possibility of selecting donors who carry this permissive polymorphism. This trial identifies and selects donors who have the favorable polymorphism at FcgammaR3A-158, thereby potentially conferring greater sensitivity to rituximab in the host after BMT.

Conditions

• Lymphoma
• B-cell Lymphoma
• Non Hodgkin Lymphoma
• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Fludarabine	Days -6 through -2: 30 mg/m\^2 IV daily
DRUG	Cyclophosphamide	Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily
RADIATION	Total body irradiation	Day -1: 200 centigray (cGy) in a single fraction
DRUG	Tacrolimus	Start on Day 5 through Day 180
DRUG	Mycophenolate Mofetil	Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
DRUG	Rituximab	Day 30 and every week after for 8 total doses: 375 mg/m\^2 IV
BIOLOGICAL	Allogeneic Bone Marrow Transplant (BMT)	Day 0: Donor bone marrow infusion

Timeline

• Start date: 2009-07-01
• Primary completion: 2013-07-01
• Completion: 2013-07-17
• First posted: 2009-07-24
• Last updated: 2018-08-27
• Results posted: 2018-07-24

Locations

1 site across 1 country: United States