Pilot Study of Using Granulocyte Colony Stimulating Factor-Primed Bone Marrow in Histocompatible Sibling Allogeneic Bone Marrow Transplantation for Patients With Hematologic Malignancies and Non-Malignancies
This study is a single-arm, non-randomized trial. Patients meeting the criteria for this
study will be entered sequentially until completion or closure of the study. Early stopping
rules will be employed to ascertain whether an unacceptable rate of toxicity
(non-engraftment, and/or acute GvHD) occurs.
Patients will be prepared for transplant through the administration of one of the following
conditioning regimen based on his/her primary disease:
5.1 Total body irradiation 1200 rads in 6 fractionated doses and high dose chemotherapy,
including etoposide and cyclophosphamide.
5.2 High dose chemotherapy with busulfan and cyclophosphamide. 5.2.1 Patients who are not
candidates for TBI will receive chemotherapy-based conditioning regimen.
5.3 Post transplant immunosuppression prophylaxis against acute GVHD will include
cyclosporine and methotrexate.
5.4 Donor will receive 3 daily G-CSF injections (starting on day -3) prior to marrow
harvest. The injections may be initiated by the donor's primary physician prior to donor's
arrival here, or by BMT service at Children's Healthcare of Atlanta.
5.5 Patients will receive daily G-CSF injections (5 mcg/kg) starting from day+5 post
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the curative potential of white cell growth hormone (G-CSF)-stimulated bone marrow cells in allogeneic bone marrow transplants.
1 year after study completion
Kuang-Yueh Chiang, M.D.
United States: Institutional Review Board
|Children's Healthcare of Atlanta/Emory University||Atlanta, Georgia 30322|