drugset / Trial / NCT00946023

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

NCT00946023 ↗

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2009-07
Primary completion
2013-07
Completion
2013-07-17

Outcome

Outcome not reported

Stopped (Business): “Funding was unavailable to complete the study as originally planned.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 50 mg/kg Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous
Background Mycophenolate Mofetil Small molecule 15 mg/kg Oral
Background Tacrolimus Small molecule — —