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Tracking Information | |||||
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First Received Date † | July 20, 2007 | ||||
Last Updated Date | October 13, 2008 | ||||
Start Date † | March 2003 | ||||
Current Primary Outcome Measures † |
The goal of this clinical research study is to see if low intensity chemoradiotherapy given with Campath-1 H, followed by a transplant of blood or marrow stem cells from a donor, can increase the length of remission in patients with T-cell lymphoma. [ Time Frame: 6 Years ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00505921 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
The goal of this clinical research study is to see if high dose chemotherapy and Campath -1H followed by a transplant of the patient's own blood stem cells can shrink or slow the growth of the lymphoma. [ Time Frame: 6 Years ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Autologous and Allogenic Transplantation With Campath-1H for T-Cell Lymphoma | ||||
Official Title † | Autologous and Allogeneic Transplantation for T-Cell Lymphoma: Impact of Campath -1H and Soluble CD52 | ||||
Brief Summary | Primary Objectives:
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Detailed Description | Autologous Stem Cell Transplantation with Campath-1H for T-cell Lymphoma: Campath is a drug that can specifically attack some types of T-cell lymphoma cells. Before the study begins, you will have a physical exam, including blood (about 2 tablespoons) and urine tests. Women who are able to have children must have a negative blood pregnancy test. Bone marrow samples will be taken. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anaesthetic and a small amount of bone marrow is withdrawn through a large needle. Patients will have a chest x-ray, an electrocardiogram (EKG) (test to measure the electrical activity of the heart), and tests of lung function. Patients whose disease affects the stomach or intestines may have biopsies of these areas. Treatment will be given in the hospital at M. D. Anderson. You will need to stay in the hospital for about 3 to 4 weeks. A central venous catheter (plastic tube) will be placed into the large chest vein. The catheter will be left in place throughout treatment. In order to collect stem cells, granulocyte colony-stimulating factor (G-CSF) and granulocyte macrophage colony-stimulating factor (GM-CSF) will be injected under the skin. This will be done twice a day until the collection of stem cells is complete. You will receive Campath-1H through the catheter on Days 1, 2, 3, and 10 of chemotherapy treatment. The stem cells will be collected from you starting about 10 to 14 days after chemotherapy is given. The collection process is called apheresis. Blood is removed from the your body and the stem cells are frozen for storage. Stem cell collection takes about 3 hours. Between 3 and 5 sessions may be needed to collect enough stem cells. Sessions will be done once a day. After stem cells are collected, you will receive high dose carmustine over 1 hour on Day 1. You will receive cytarabine and etoposide twice a day on Days 2 through 5, and melphalan on Day 6. One day after finishing the chemotherapy, the stem cells that were collected earlier will be infused back into you over about 30 minutes. G-CSF and GM-CSF will be injected until your white blood cell counts returns to normal. Blood tests (1-2 tablespoons), urine tests, bone marrow sampling, and x-rays will be done as needed to track the effects of the transplant. You will have transfusions of blood and platelets as needed. Blood tests (1-2 tablespoons) will be done daily while you are in the hospital. You might have to stay in the Houston area for 2 to 4 weeks after the transplant. After that, you will need to return to Houston every 3 months for the first year, then every 6 months for 5 years. Three months after the transplant, bone marrow exams and other tests will be done. If you show evidence of disease, you will receive another cycle of Campath-1H three times a week for 4-12 weeks. Patients will be taken off the study if the disease gets worse or intolerable side effects occur. This is an investigational study. The FDA has approved the drugs used in this study. Their use together in this study is investigational. About 30 patients will take part in this study. All will be enrolled at M. D. Anderson. Nonmyeloablative Allogeneic Transplantation with Campath-1H for T-cell Lymphoma: Campath is a drug that can specifically attack some types of T-cell lymphoma cells. In addition, it weakens the immune system, therefore helping to prevent the rejection of donor marrow or stem cells. Total body irradiation (TBI) is designed to damage the DNA (the genetic material of cells) of cancer cells, which may kill the cancer cells. Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die. Fludarabine is designed to make cancer cells less able to repair damaged DNA. This may increase the likelihood of the cells dying. Before the study begins, you will have a physical exam, including blood (about 1-2 tablespoons) and urine tests. Women who are able to have children must have a negative blood pregnancy test. Bone marrow samples will be taken. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anaesthetic and a small amount of bone marrow is withdrawn through a large needle. You will have a chest x-ray, CT scans, an EKG (test to measure the electrical activity of the heart), and tests of lung function. Blood tests (1-2 tablespoons), urine tests, bone marrow sampling, and x-rays will be done as needed to track the effects of the transplant. Patients will have transfusions of blood and platelets as needed. Blood tests (1-2 tablespoons) will be done daily while you are in the hospital. Campath-1 H will be injected into your vein. This will be done 3 days in a row (Days 1 to 3). The drugs diphenhydramine (Benadryl), acetaminophen (Tylenol), and hydrocortisone will be given in to decrease the risk of or ease side effects. You will also receive fludarabine and cyclophosphamide daily for 3 days. They will be given starting day of Campath -1H. 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. After completion of chemotherapy, you will receive TBI, and later on the same day, blood stem cells from a donor will be given through the catheter. G-CSF and GM-CSF, growth factors that promote the production of blood cells, will be injected under the skin once a day until the neutrophil counts recover in the blood. Tacrolimus will be infused through the vein, starting 2 days before transplant to decrease the risk of graft-versus-host disease. It will be changed to pills after you are discharged from the hospital. For the same purpose, methotrexate will also be given through the vein on Days 1, 3, 6 (and Day 11 if unrelated donor). Treatment will be given in the hospital at UTMDACC. You will need to stay in the hospital for about 3 to 4 weeks. You must stay in the Houston area for about 100 days after the transplant. After that, you will need to return to Houston every 3 months for the first year, then every 6 months for 5 years for blood tests (1-2 tablespoons), urine tests, and CT scans. Bone marrow aspirations and biopsies will also be performed. Patients will be taken off the study if the intolerable side effects occur. This is an investigational study. The FDA has approved the drugs used in this study. Their use together in this study is investigational. About 30 patients will take part in this study. All will be enrolled at UTMDACC. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
Condition † | Lymphoma | ||||
Intervention † | Drug: Campath-1H | ||||
Study Arms / Comparison Groups | Experimental: Campath-1H | ||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 30 | ||||
Completion Date | |||||
Estimated Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | up to 70 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00505921 | ||||
Responsible Party | Issa F. Khouri, MD/Professor, U.T.M.D. Anderson Cancer Center | ||||
Secondary IDs †† | |||||
Study Sponsor † | M.D. Anderson Cancer Center | ||||
Collaborators †† | Berlex Oncology | ||||
Investigators † |
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Information Provided By | M.D. Anderson Cancer Center | ||||
Verification Date | October 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |