Safety and Efficacy of Campath in Nonmyeloablative Transplantation
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 The bone marrow is then withdrawn through the needle.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
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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants Surviving 100 days post-transplant
30 Day Engraftment (Baseline) to 100 Days post-transplant
Issa F. Khouri, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|U.T.M.D. Anderson Cancer Center||Houston, Texas 77030|