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Glossary
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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00383994 |
Primary Objectives:
Condition | Intervention |
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Lymphoma Leukemia Stem Cell Transplantation |
Drug: GM-CSF Drug: Rituximab Biological: NK Cell Infusion |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Immunotherapy With NK Cell, Rituximab and Rhu-GMCSF in Non-Myeloablative Allogeneic Stem Cell Transplantation |
Estimated Enrollment: | 40 |
Study Start Date: | September 2006 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Immunotherapy in Non-myeloablative Allogeneic Stem Cell Transplantation
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Drug: GM-CSF
250 micrograms subcutaneously 3 times a week for 4 weeks starting a day before the administration of Rituximab.
Drug: Rituximab
375 mg/m^2 followed by 1000 mg/m^2 weekly for 3 weeks for a total of 4 doses.
Biological: NK Cell Infusion
NK cells will be infused one week after the fourth dose of Rituximab and GM-CSF.
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Rituximab is designed to attach to lymphoma cells, causing them to die. GM-CSF and NK cells may increase rituximab's ability to kill these cells.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have your complete medical history recorded and a physical exam. Your blood (about 2 tablespoons) will be collected for routine tests. A bone marrow aspirate will be performed. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. You will have computerized tomography (CT) scans as well as positron emission tomography (PET) or gallium scans to learn the status of your disease. Women who are able to have children must have a negative blood or urine pregnancy test.
If you are found eligible to take part in this study, you will receive treatment as an outpatient. You will receive GM-CSF 3 times a week for 4 weeks through a vein, starting the day before you receive the administration of rituximab. You will receive rituximab over 4 to 8 hours through a vein, once weekly for 4 weeks. You will also get a boost of NK cells from the same donor from whom you received your original transplant. These cells will be infused through a vein (over 30 to 60 minutes) after the 4th dose of rituximab. If you are receiving a cell infusion from somebody who you are not related to, the infusion may have to be done later if cells were not available as scheduled.
During this treatment, you will be examined as needed, and blood samples (1 tablespoon once or twice a week) will be taken for routine tests. You may need to receive blood transfusions during this study if your blood cell counts remain low.
You may be taken off this study if your disease gets worse or intolerable side effects occur.
You will have long-term, follow-up visits while on study. You will be seen at 4 to 6 weeks after you receive NK cell infusion; every 3 months during the first year; and then once a year. During each of these visits, you will have CT and PET scans, a bone marrow biopsy, and blood drawn (about 4 teaspoons) to learn the status of your disease.
This is an investigational study. Rituximab and GM-CSF are FDA approved and commercially available. NK cells are authorized by the FDA for use in research only. Up to 40 participants will take part in this study. All will be enrolled at M. D. Anderson.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Issa F. Khouri, MD | 713-745-2803 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Issa F. Khouri, MD |
Principal Investigator: | Issa F. Khouri, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Issa F. Khouri, MD/Professor ) |
Study ID Numbers: | 2005-0234 |
Study First Received: | October 2, 2006 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00383994 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Chronic Lymphocytic Leukemia CLL Non-Hodgkin's Lymphoma B-Cell Lymphoma Lymphoma Leukemia |
NK Cells Rituximab GM-CSF Non-myeloablative Allogeneic Stem Cell Transplantation Stem Cell Transplant |
Leukemia, Lymphoid Immunoproliferative Disorders Immunologic Factors Rituximab Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse Leukemia Lymphatic Diseases |
Chronic Lymphocytic Leukemia B-cell Lymphomas Leukemia, Lymphocytic, Chronic, B-Cell Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Leukemia, B-cell, Chronic Lymphoma |
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunologic Factors Antineoplastic Agents Rituximab Physiological Effects of Drugs Pharmacologic Actions |
Leukemia Lymphatic Diseases Neoplasms Therapeutic Uses Lymphoproliferative Disorders Antirheumatic Agents Lymphoma |