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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00038844 |
Objective of the low-dose transplant regimen must produce the following effects:
Condition | Intervention |
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Lymphoma Leukemia |
Drug: Campath-1 H (Alemtuzumab) Drug: Fludarabine Drug: Cyclophosphamide Drug: Rituximab |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy of Campath in Nonmyeloablative Transplantation |
Estimated Enrollment: | 100 |
Study Start Date: | June 2001 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Campath-1 H + Fludarabine + Cyclophosphamide + rituximab
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Drug: Campath-1 H (Alemtuzumab)
Starting Dose of 15 mg by vein daily, 3 days in a row.
Drug: Fludarabine
30 mg/m2 by vein daily, 3 days in a row.
Drug: Cyclophosphamide
1 gm/m2 by vein daily, 3 days in a row.
Drug: Rituximab
375 mg/m2 by vein, given (to some patients only, based on the subtypes of lymphomas) eight days before the transplant and then weekly for a total of 4 doses.
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Alemtuzumab is a drug that can specifically attack some types of leukemia and lymphoma cells. In addition, it suppresses the patients' immune system, therefore helps preventing the rejection of donor marrow or stem cells.
Before treatment starts, patients will have a physical exam, including blood tests (between 100 - 120 cc) and urine tests. Women who are able to have children will have a pregnancy test. Bone marrow samples will be taken. Patients will have a chest x-ray, CT scans and EKG, and tests of lung function.
Blood tests (between 100 - 120 cc) marrow sampling, and x-rays will be done as needed to track the effects of the transplant. For bone marrow sampling, a large needle is placed into the numbed hipbone. The bone marrow is then withdrawn through the needle. Patients will have transfusions of blood and platelets as needed. Blood tests (between 100 - 120 cc) will be done daily while patients are in the hospital.
Alemtuzumab will be injected into the patient's vein. This will be done 3 days in a row (days 1 to 3). The drugs diphenhydramine (Benadryl) and acetaminophen (Tylenol) will be given in to prevent or ease side effects.
Patients will also receive fludarabine and cyclophosphamide daily for 3 days. They will be given on the same days as alemtuzumab. Rituximab will be given (to some patients only, based on the subtypes of lymphomas) eight days before the transplant and then weekly for a total of 4 doses.
All of the chemotherapy drugs will be given through a catheter (plastic tube) that extends into the large chest vein. The catheter will be left in place throughout treatment. When chemotherapy is finished, blood stem cells from a donor will be given through the catheter. G-CSF, a growth factor that promotes the production of blood cells, will be injected under the skin once a day until the neutrophil counts recover in the blood.
A "boost" of donor cells (lymphocytes) will be given at 3 months after transplant if the disease is getting worse or if DNA tests from the blood shows that not all lymphocytes in the blood are from the donor. These cells will be given through the vein, without chemotherapy, in the clinic.
Treatment will be given in the hospital at M. D. Anderson. Patients will need to stay in the hospital for about 3 to 4 weeks. Patients will be taken off study if their disease progresses.
Patients must stay in the Houston area for about 100 days after the transplant. After that, patients will need to return to Houston from time to time for blood tests, urine tests, and other exams.
This is an investigational study. The FDA has approved the drugs used in this study. Their use together in this study is investigational. About 100 patients will take part in this study. All will be enrolled at M. D. Anderson.
Ages Eligible for Study: | up to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
U.T.M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Issa F. Khouri, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | UT MD Anderson Cancer Center ( Issa F. Khouri, MD, BS/Professor ) |
Study ID Numbers: | ID01-200 |
Study First Received: | June 5, 2002 |
Last Updated: | February 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00038844 History of Changes |
Health Authority: | United States: Institutional Review Board |
Lymphoma Leukemia Campath-1 H Campath Alemtuzumab Fludarabine Fludarabine Phosphate |
Fludara Cyclophosphamide Cytoxan Neosar Rituxan Rituximab |
Antimetabolites Immunoproliferative Disorders Immunologic Factors Rituximab Cyclophosphamide Fludarabine monophosphate Immunosuppressive Agents Leukemia |
Lymphatic Diseases Alemtuzumab Antineoplastic Agents, Alkylating Fludarabine Lymphoproliferative Disorders Antirheumatic Agents Alkylating Agents Lymphoma |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Leukemia Alemtuzumab Therapeutic Uses Lymphoma Alkylating Agents Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Rituximab Fludarabine monophosphate Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Myeloablative Agonists Fludarabine Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Antirheumatic Agents |