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Sponsored by: |
University of Michigan Cancer Center |
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Information provided by: | University of Michigan Cancer Center |
ClinicalTrials.gov Identifier: | NCT00141700 |
This study is being conducted to determine the safety, side effects, and response to a combination of an established high-dose chemotherapy regimen, stem cell support and Rituximab (which is a form of immunotherapy).
Condition | Intervention | Phase |
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Lymphoma, Non-Hodgkin's |
Drug: Rituximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Rituximab Plus High-Dose Chemotherapy With Autologous Stem Cell Support for Poor-Prognosis Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 30 |
Study Start Date: | March 2003 |
Study Completion Date: | December 2005 |
Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
Combination chemotherapy is the standard treatment as initial therapy for aggressive NHL. Standard chemotherapy cures less than 40% of patients. High-dose chemotherapy with stem cell support (or transplant) is showing some positive results in patients with NHL that fail standard chemotherapy. The cure rate of this treatment is only about 50%.
Another treatment option called immunotherapy is being tested in lymphoma patients to see if adding immunotherapy to NHL treatments improves results. Rituximab, a form of immunotherapy, is an antibody (a type of protein) that attacks the CD20 protein found on lymphoma cell, which may result in the death of the lymphoma cell.
The study design is as follows: Patients with poor prognosis NHL receive rituximab as part of the peripheral blood progenitor cell mobilization process and as part of the preparative regimen in combination with high-dose chemotherapy. Granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood progenitor cells (PBPC) are collected and stored. After recovery from high-dose cyclophosphamide, patients are admitted to the hospital for transplant. The preparative regimen consists of rituximab, followed by high-dose chemotherapy.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Michigan | |
The University of Michigan | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Raymond J. Hutchinson, MD | The University of Michigan |
Study ID Numbers: | UMCC 2-51 |
Study First Received: | August 30, 2005 |
Last Updated: | December 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00141700 |
Health Authority: | United States: Institutional Review Board |
Lymphatic Diseases Immunoproliferative Disorders Rituximab Lymphoma, small cleaved-cell, diffuse |
Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |