An interventional study of Campath-1 H (Alemtuzumab) and Fludarabine in Lymphoma and Leukemia, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged Up to 70 Years. Per ClinicalTrials.gov, last updated 2011-11-02.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Treatment
Objective of the low-dose transplant regimen must produce the following effects:
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 The bone marrow is then withdrawn through the needle.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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 65 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
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Exclusion Criteria:
Campath-1 H Starting Dose of 15 mg by vein daily, 3 days in a row + Fludarabine 30 mg/m2 by vein daily, 3 days in a row + Cyclophosphamide 1 gm/m2 by vein daily, 3 days in a row + Rituximab 375 mg/m2 by vein, given 8 days before transplant then weekly for 4 total doses.
Drug: Campath-1 H (Alemtuzumab) · Drug: Fludarabine · Drug: Cyclophosphamide · Drug: Rituximab
Starting Dose of 15 mg by vein daily, 3 days in a row.
Also known as: Campath, Alemtuzumab
30 mg/m2 by vein daily, 3 days in a row.
Also known as: Fludarabine Phospate, Fludara
1 gm/m2 by vein daily, 3 days in a row.
Also known as: Cytoxan, Neosar
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.
Also known as: Rituxan
Number of Participants Surviving 100 days post-transplant
Time frame: 30 Day Engraftment (Baseline) to 100 Days post-transplant
This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center