Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231309
Status:
COMPLETED
Last Update Posted:
2014-08-22
First Post:
2005-10-03
Brief Title:
Granulocyte Colony Stimulating Factor G-CSF for Bone Marrow Transplant BMT
Sponsor:
Emory University
Organization:
Emory University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 andor chemotherapy will be given first to prepare the patients 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 patients body host graft-versus-host disease GVHD Certain safety checkpoints were built into the study if unwantedunexpected 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
Detailed Description:
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 andor acute GvHD occurs
Patients will be prepared for transplant through the administration of one of the following conditioning regimen based on hisher primary disease
51 Total body irradiation 1200 rads in 6 fractionated doses and high dose chemotherapy including etoposide and cyclophosphamide
52 High dose chemotherapy with busulfan and cyclophosphamide 521 Patients who are not candidates for TBI will receive chemotherapy-based conditioning regimen
53 Post transplant immunosuppression prophylaxis against acute GVHD will include cyclosporine and methotrexate
54 Donor will receive 3 daily G-CSF injections starting on day -3 prior to marrow harvest The injections may be initiated by the donors primary physician prior to donors arrival here or by BMT service at Childrens Healthcare of Atlanta
55 Patients will receive daily G-CSF injections 5 mcgkg starting from day5 post transplant
Patients will be prepared for transplant through the administration of one of the following conditioning regimen based on hisher primary disease
51 Total body irradiation 1200 rads in 6 fractionated doses and high dose chemotherapy including etoposide and cyclophosphamide
52 High dose chemotherapy with busulfan and cyclophosphamide 521 Patients who are not candidates for TBI will receive chemotherapy-based conditioning regimen
53 Post transplant immunosuppression prophylaxis against acute GVHD will include cyclosporine and methotrexate
54 Donor will receive 3 daily G-CSF injections starting on day -3 prior to marrow harvest The injections may be initiated by the donors primary physician prior to donors arrival here or by BMT service at Childrens Healthcare of Atlanta
55 Patients will receive daily G-CSF injections 5 mcgkg starting from day5 post transplant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None