Status:
COMPLETED
Rituximab in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant for Relapsed or Refractory B-cell Lymphoma
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
American Cancer Society, Inc.
National Cancer Institute (NCI)
Conditions:
B-cell Adult Acute Lymphoblastic Leukemia
B-cell Childhood Acute Lymphoblastic Leukemia
Eligibility:
All Genders
Phase:
PHASE2
Brief 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...
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...
Eligibility Criteria
Inclusion
- With a diagnosis of CD20-expressing B-cell malignancy of any histologic type or grade for whom non-myeloablative allogeneic transplant is considered an appropriate treatment option
- Who are enrolled on a non-myeloablative allogeneic HCT protocol employing total-body irradiation (TBI)-based conditioning of =\< 4.5 Gy, with or without fludarabine; this protocol may be used as an adjunct to the allogeneic arm of a tandem autologous/allogeneic transplant protocol, provided the allogeneic conditioning meets the above criteria
- Receiving unmodified peripheral blood mononuclear cell graft products
- With an appropriate related or unrelated donor; human leukocyte antigen (HLA)-haploidentical donors are excluded
- Able to give informed consent (if \>= 18 years of age), or with a legal guardian capable of giving consent (if \< 18 years of age)
Exclusion
- Ineligible for non-myeloablative allogeneic HCT
- Receiving an HLA-haploidentical allograft
- Who are fertile but unwilling to use contraception during and for at least 12 months after HCT
- Females who are pregnant or breast-feeding
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2015
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00867529
Start Date
February 1 2009
End Date
March 26 2015
Last Update
January 2 2018
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109