Trial of Allogeneic BMT for Hematologic Malignancies Using HLA-matched Related or Unrelated Donors With Fludarabine and IV Busulfan as Pre-transplant Conditioning Followed by Post-transplant Immunosuppression With High-dose Cyclophosphamide
A person who has cancer of the blood or lymph glands can be treated by bone marrow
transplantation (BMT). BMT has developed over several decades of research on both animal
and human subjects as an effective treatment of various malignant and nonmalignant
hematologic diseases. Many hematologic malignancies can be successfully treated with a
combination of high-dose chemotherapy or chemo-radiotherapy and transplantation of
allogeneic bone marrow or peripheral blood stem cells (alloBMT)
However, a possible side effect of BMT is graft versus host disease (GVHD). GVHD occurs
when cells of the donor's immune system, which are present in the bone marrow, attack the
BMT recipient's normal tissue. Prevention of GVHD is important for the success of the bone
marrow transplant. This research is being done to find the most effective and least toxic
way to prevent GVHD after BMT
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the optimal regimen of post-graft immunosuppression with high-dose Cy following fludarabine, busulfan, and transplantation of fully HLA-matched bone marrow that leads to an acceptable incidence of grades III/IV acute GVHD.
1 year
Yes
Leo Luznik, MD
Study Chair
Johns Hopkins University
United States: Institutional Review Board
J0844
NCT00809276
May 2009
December 2011
Name | Location |
---|---|
The Sydney Kimmel Comprehensive Cancer center | Baltimore, Maryland 21231 |
Marcos deLima, MD | Houston, Texas 77030 |
Paul V. O'Donnell, M.D., Ph.D. | Seattle, Washington 98109 |