Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation of Patients With Hematological Diseases
Status:
Completed
Trial end date:
2006-12-01
Target enrollment:
Participant gender:
Summary
Participants in this study have a hematologic malignancy (a disorder in the bone marrow that
affects the body's ability to create blood) that might benefit from receiving an allogeneic
stem cell transplant (meaning the cells come from a donor) from a family member or nearly
identical matched donor. The donor may either be a matched sibling, a mismatched family
member, or an unrelated person.
Usually these patients are given high doses of chemotherapy before receiving a stem cell
transplant to keep their immune system from rejecting the donor stem cells and to kill any
diseased cells that remain in the body. However, this group of patients have a high risk of
developing possibly life-threatening treatment-related side effects such as infections,
damage to vital organs such as lungs, liver, kidney and heart, as well as graft versus host
disease (GVHD).
Instead of the high dose chemotherapy and radiotherapy usually given before a transplant,
this research study uses a new pre-transplant combination of three drugs, Fludarabine,
Anti-CD45 and CAMPATH-1H with low dose radiotherapy. Fludarabine is a chemotherapy drug while
Anti-CD45 and CAMPATH-1H are antibodies against certain types of blood cells, including those
which are causing this disease. CAMPATH-1H is particularly important because it stays active
in the body for a long time after it is given, which means it may work longer to prevent GVHD
symptoms. Anti-CD45 may help in eradicating residual malignant cells. All these agents also
help in preventing rejection of donor stem cells. This study is designed to give a less
intense chemotherapy and radiotherapy, so that the life-threatening toxicities of
conventional high dose chemotherapy and radiotherapy regimen can be reduced, while
maintaining the ability to cure cancer.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Baylor College of Medicine
Collaborators:
Center for Cell and Gene Therapy, Baylor College of Medicine Texas Children's Hospital The Methodist Hospital Research Institute The Methodist Hospital System