Modified Bone Marrow Stem Cell Transplantation for Chronic Myelogenous Leukemia
Status:
Completed
Trial end date:
2002-10-01
Target enrollment:
Participant gender:
Summary
This study will investigate the safety and effectiveness of a new stem cell transplant
procedure for treating chronic myelogenous leukemia (CML).
Transplantation of donated stem cells (cells produced by the bone marrow that mature into the
different blood components-white cells, red cells and platelets) is a very effective
treatment for CML. However, despite its success in a large number of patients, there is still
a significant risk of death from the procedure. In addition, it results in sterility and
leaves patients at increased risk for other cancers and for eye cataracts. These
complications result from the intensive chemotherapy and radiation patients receive before
the transplant to rid the body of cancer cells. In this study, radiation will not be used and
chemotherapy drugs will be given in lower doses to try to reduce the dangers of the
procedure.
Patients with CML will be tested for matching with a donor (family member) and will undergo a
medical history, physical examination and several tests (e.g., breathing tests, X-rays, and
others) to determine eligibility for the study. Participants will then undergo apheresis to
collect lymphocytes (white blood cells important in the immune system). In apheresis, whole
blood is drawn through a needle in the arm, similar to donating a unit of blood. The required
component-in this case, lymphocytes-are separated and removed, and the rest of the blood is
returned through a needle in the other arm.
Each day starting five days before the transplant, the donor will be given an injection of
G-CSF, a drug that releases stem cells from the bone marrow into the blood stream. The cells
will be collected after the fifth injection and again after a sixth injection the following
day. Meanwhile, patients will be given cyclophosphamide and fludarabine, and perhaps
anti-thymocyte globulin, to prevent rejection of the donated cells.
On the day of the transplant, patients will be given cyclosporin to prevent
graft-versus-host-disease, a disease in which the donor cells react against the patient's
cells. They may also be given lymphocytes after the transplant to boost the immune system and
destroy leukemia cells. After 30, 60 and 100 days, bone marrow cells and circulating
lymphocytes will be checked to see how many are of donor cell origin. If less than 100
percent are of donor origin, more lymphocytes will be transfused. Patients will have physical
examinations and blood tests at least weekly for 3 months and then periodically for 5 years.