Granulocyte Colony Stimulating Factor (G-CSF) for Bone Marrow Transplant (BMT)
| Status: | Archived |
|---|---|
| Conditions: | Cancer, Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
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
The major purpose of this study is to evaluate the curative potential of white cell growth
hormone (G-CSF)-stimulated bone marrow cells in allogeneic bone marrow transplants. Patients
with cancers or blood diseases, who have poor potential for a cure with standard treatment,
will be able to participate in the study. Donors will receive the white cell growth hormone
(G-CSF) as a shot (injection) in their arm once a day for three days before they donate
their bone marrow cells. Total body irradiation and/or chemotherapy will be given first to
prepare the patient's body for the infusion of new bone marrow cells from the donor. Two
medicines (cyclosporine and methotrexate) will be used to prevent the new bone marrow cells
(graft) from attacking the patient's body (host) (graft-versus-host disease; GVHD). Certain
safety checkpoints were built into the study if unwanted/unexpected events were to occur. If
the outcomes appear better than could be expected, this will provide a bridge to extend this
current approach for other innovative therapies.
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.
We found this trial at
1
site
Atlanta, Georgia 30308
Click here to add this to my saved trials
