Clinical Trials Directory

Trials / Completed

CompletedNCT00867529

Rituximab in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant for Relapsed or Refractory B-cell Lymphoma

Addition of Pre- and Post-Transplant Rituximab for Patients Undergoing Non-myeloablative Allogeneic Hematopoietic Cell Transplantation With Relapsed or Refractory CD20+ B-Cell Malignancies

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
63 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
—
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALrituximabGiven IV
PROCEDUREperipheral blood stem cell transplantationUndergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation
PROCEDUREnonmyeloablative allogeneic hematopoietic stem cell transplantationUndergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation
OTHERpharmacological studyCorrelative studies
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2009-02-01
Primary completion
2015-03-01
Completion
2015-03-26
First posted
2009-03-23
Last updated
2018-01-02
Results posted
2017-05-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00867529. Inclusion in this directory is not an endorsement.