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Sponsors and Collaborators: |
Stanford University The Leukemia and Lymphoma Society |
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Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00186628 |
To determine if Rituximab administered after allogeneic transplantation decreases the incidence of chronic GvHD
Condition | Intervention | Phase |
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Leukemia, Mast-Cell |
Procedure: nonmyeloablative allogeneic hematopoietic cell transplant |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label, Phase II Trial of Prophylactic Rituximab Therapy for Prevention of Chronic Graft Versus Host Disease After TLI/ARG Nonmyeloablative Allogeneic Stem Cell Transplantation |
Estimated Enrollment: | 35 |
Study Start Date: | June 2005 |
To test if prophylactic Rituximab given to 35 patients 60-90 days after allogeneic transplantation will prevent chronic Graft-versus-Host Disease
Ages Eligible for Study: | 17 Years to 76 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Donor Inclusion Criteria
Exclusion Criteria:
Standard exclusions for any allogeneic transplantation including:
Donor Exclusion Criteria
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | David Miklos | Stanford University |
Principal Investigator: | Sally Arai | Stanford University |
Study ID Numbers: | BMT172, 96160, BMT172, NCT00186628, PO1 CA 49605 |
Study First Received: | September 14, 2005 |
Last Updated: | May 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00186628 |
Health Authority: | United States: Institutional Review Board |
Rituximab Graft versus host disease Leukemia, Mast-Cell Leukemia, Myeloid Mast cell disease Leukemia, Myeloid, Acute Homologous wasting disease |
Leukemia Neoplasms, Connective and Soft Tissue Mastocytosis, Systemic Graft vs Host Disease Mastocytosis Mastocytoma Leukemia, mast-cell |
Neoplasms Neoplasms by Histologic Type Immune System Diseases Neoplasms, Connective Tissue |