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Addition of Pre- and Post-Transplant Rituximab for Patients Undergoing Non-myeloablative Allogeneic Hematopoietic Cell Transplantation With Relapsed or Refractory CD20+ B-Cell Malignancies
This phase II trial studies giving rituximab before and after a donor peripheral blood stem cell transplant in patients with B-cell lymphoma that does not respond to treatment (refractory) or has come back after a period of improvement (relapsed). Monoclonal antibodies, such as rituximab, can interfere with the ability of cancer cells to grow and spread. Giving rituximab before and after a donor peripheral blood stem cell transplant may help stop cancer from coming back and may help keep the patient's immune system from rejecting the donor's stem cells.
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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 (GVHD). 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 allogeneic HCT. VII. To describe donor and host polymorphisms of the FC gamma receptor IIIa (FCg RIIIA) and CD32 and evaluate their impact on disease response and relapse. OUTLINE: 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 periodically for 18 months and then annually for 5 years.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Start Date
February 1, 2009
Primary Completion Date
March 1, 2015
Completion Date
March 26, 2015
Last Updated
January 2, 2018
63
ACTUAL participants
rituximab
BIOLOGICAL
peripheral blood stem cell transplantation
PROCEDURE
nonmyeloablative allogeneic hematopoietic stem cell transplantation
PROCEDURE
pharmacological study
OTHER
laboratory biomarker analysis
OTHER
Lead Sponsor
Fred Hutchinson Cancer Center
Collaborators
NCT00381680
NCT01925131
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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