Granulocyte Colony Stimulating Factor (G-CSF) for Bone Marrow Transplant (BMT)
|Hematologic Diseases Hematologic Malignancies||Drug: Granulocyte Colony Stimulating Factor|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Numbers of Participants With Disease-free Survival. [ Time Frame: 260 days ]Evaluate the numbers of participants with disease-free survival
- Hospital Length of Stay [ Time Frame: inpatient hospital stay ]hospital length of stay of each patient enrolled, an average of 5 weeks.
|Study Start Date:||July 2003|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Drug: Granulocyte Colony Stimulating Factor
Granulocyte Colony Stimulating Factor
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 transplant.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231309
|United States, Georgia|
|Children's Healthcare of Atlanta/Emory University|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Kuang-Yueh Chiang, M.D.||Emory University/CHOA|