Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228813
Status:
TERMINATED
Last Update Posted:
2017-09-11
First Post:
2005-09-27
Brief Title:
G-CSF PMRD Granulocyte Colony Stimulating Factor G-CSF Stimulated Bone Marrow and In Vivo T-Cell Depletion in Patients With Hematologic Malignancies or Bone Marrow Failure Syndrome
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Feasibility Study of Using G-CSF Stimulated Bone Marrow and In Vivo T-Cell Depletion in Patients With Hematologic Malignancies or Bone Marrow Failure Syndrome With Partially Mismatched Related Donors
Status:
TERMINATED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
G-CSF PMRD
Brief Summary:
The purposes of this study are
To examine the engraftment rate in patients receiving in vivo T-cell-depleted G-CSF stimulated bone marrow from partially mismatched related donors
To evaluate the incidence and severity of acute and chronic graft-versus-host disease in patients receiving in vivo T-cell-depleted G-CSF stimulated bone marrow from partially mismatched related donors
To examine the engraftment rate in patients receiving in vivo T-cell-depleted G-CSF stimulated bone marrow from partially mismatched related donors
To evaluate the incidence and severity of acute and chronic graft-versus-host disease in patients receiving in vivo T-cell-depleted G-CSF stimulated bone marrow from partially mismatched related donors
Detailed Description:
This study is a single-arm non-randomized feasibility study 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 the following conditioning regimen based on their primary disease
Total body irradiation 1400 rads in 8 fractionated doses and high dose chemotherapy including cytosine arabinoside etoposide and cyclophosphamide Patients with bone marrow failure syndrome will not receive etoposide in the conditioning regimen
Post transplant immunosuppression prophylaxis against acute GVHD will include sequential administration of cyclosporine methotrexate basiliximab and mycophenolate
The donor will receive 3 daily G-CSF injections prior to marrow harvest starting on day -3 The injections may be initiated by the donors primary physician prior to donors arrival or by the BMT service at Childrens Healthcare of Atlanta
Patients will receive daily GM-CSF injections 250 mcgm2 starting from day 7 post transplant until absolute neutrophil count ANC is greater than 2000µL for three days
Patients will be prepared for transplant through the administration of the following conditioning regimen based on their primary disease
Total body irradiation 1400 rads in 8 fractionated doses and high dose chemotherapy including cytosine arabinoside etoposide and cyclophosphamide Patients with bone marrow failure syndrome will not receive etoposide in the conditioning regimen
Post transplant immunosuppression prophylaxis against acute GVHD will include sequential administration of cyclosporine methotrexate basiliximab and mycophenolate
The donor will receive 3 daily G-CSF injections prior to marrow harvest starting on day -3 The injections may be initiated by the donors primary physician prior to donors arrival or by the BMT service at Childrens Healthcare of Atlanta
Patients will receive daily GM-CSF injections 250 mcgm2 starting from day 7 post transplant until absolute neutrophil count ANC is greater than 2000µL for three days
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 0159-2004 | OTHER | Emory University | None |