Addition of Pre- and Post-transplant Rituximab for Patients Undergoing Non-myeloablative Allogeneic Hematopoietic Cell Transplantation With Relapsed or Refractory CD20+ B-cell Malignancies
I. To determine the effect of addition of peri-transplant rituximab on relapse rate at 18
months after non-myeloablative allogeneic hematopoietic cell transplant (HCT) for cluster of
differentiation (CD)20+ B-cell malignancies.
I. To determine overall and progression-free survival and non-relapse mortality.
II. To determine the incidence and severity of acute and chronic graft-versus-host disease
III. To determine the rate of graft rejection and graft failure.
IV. To determine the time to engraftment.
V. To determine the incidence of serious adverse events with the addition of rituximab.
VI. To evaluate the pharmacokinetics of rituximab in the setting of non-myeloablative
VII. To describe donor and host polymorphisms of the FCgammaRIIIa receptor and CD32 and
evaluate their impact on disease response and relapse.
Patients receive rituximab intravenously (IV), pre- and post-transplant, on days -3, 10, 24,
and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment
continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 year and then annually
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Effectiveness of pre- and post-transplant rituximab in decreasing the disease relapse rate
At 18 months
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|