Reduced-intensity, Related-donor Allogeneic BMT With Fludarabine, Busulfan, and High-dose Posttransplantation Cyclophosphamide for Hematologic Malignancies
At the present time there are few or no cures for people with cancer of the blood or lymph
glands outside of a bone marrow transplant (BMT). BMT has developed over several decades of
research as an effective treatment of various malignant and nonmalignant hematologic
This research is being done to learn more about reduced-intensity bone marrow
transplantation (BMT), also known as a "mini" transplant for patients with blood cancers,
using bone marrow from a relative. The bone marrow for this transplant comes from a relative
who is a half-match or "haplo" match to you. Possible donors include parents, siblings, and
"Mini" transplants have been given to many people with various cancers but are considered
experimental. Over 200 people at Johns Hopkins have received mini transplants with high
doses of cyclophosphamide after the transplant. However, the chemotherapy combination and
other treatment given before those transplants were different from what is in this study.
Although all of the chemotherapy and immune-lowering drugs used in this study are approved
by the Food and Drug Administration (FDA), the combination of medications used in this study
are not FDA approved and are experimental.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Estimate the proportion of patients achieving full donor chimerism
After reduced-intensity, partially (Human leukocyte antigen) HLA-mismatched or HLA-matched BMT with fludarabine, busulfan, and post-grafting immunosuppression that includes high-dose cyclophosphamide, estimate the proportion achieving full donor chimerism by Day 60 in unsorted and CD3+ sorted peripheral blood.
Yvette Kasamon, M.D.
Johns Hopkins University
United States: Institutional Review Board
|The Sydney Kimmel Comprehensive Cancer center||Baltimore, Maryland 21231|