Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084695
Status:
UNKNOWN
Last Update Posted:
2014-01-10
First Post:
2004-06-10
Brief Title:
Umbilical Cord Blood for Stem Cell Transplantation in Treating Young Patients With Malignant or Nonmalignant Diseases
Sponsor:
Milton S Hershey Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
The Use Of Umbilical Cord Blood As A Source Of Hematopoietic Stem Cells
Status:
UNKNOWN
Status Verified Date:
2008-10
Last Known Status:
RECRUITING
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:
RATIONALE Umbilical cord blood transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy
PURPOSE This phase II trial is studying how well umbilical cord blood works as a source of stem cells in treating patients with types of cancer as well as other diseases
PURPOSE This phase II trial is studying how well umbilical cord blood works as a source of stem cells in treating patients with types of cancer as well as other diseases
Detailed Description:
OBJECTIVES
Primary
Determine the impact of the use of umbilical cord blood as a source of hematopoietic stem cells for children with life-threatening oncologic hematologic or geneticmetabolic disorders in need of a stem cell transplant
Compare the incidence of graft-versus-host disease in patients receiving cord blood transplants in this study with historical data for unrelated donor stem cell transplants
Compare the incidence of engraftment in patients receiving cord blood transplants in this study with historical data for unrelated donor stem cell transplants
OUTLINE
Preparative therapy Patients are treated on 1 of 4 preparative therapy regimens
Regimen A Patients undergo total body irradiation TBI two times daily on days -7 to -4 Patients receive cyclophosphamide IV over 30-60 minutes on days -3 and -2 and anti-thymocyte globulin ATG IV over at least 6 hours on days -3 to -1
Regimen B patients who do not receive TBI Patients receive oral busulfan 4 times daily on days -8 to -5 and ATG IV over at least 6 hours and melphalan IV over 15-20 minutes on days -4 to -2
Regimen C patients with Fanconis anemia and related disorders Patients undergo TBI on day -6 Patients receive ATG IV over at least 6 hours and methylprednisolone IV on days -5 to -1 and fludarabine IV over 30 minutes and cyclophosphamide IV over 30-60 minutes on days -5 to -2
Regimen D Patients receive oral or IV busulfan 4 times daily on days -9 to -5 ATG IV over at least 6 hours on days -5 to -3 and cyclophosphamide IV over 30-60 minutes on days -5 to -2
Cord blood transplant All patients undergo umbilical cord blood transplantation on day 0
Graft-versus-host disease prophylaxis Patients receive oral or IV cyclosporine twice daily beginning on day -1 Patients also receive methylprednisolone IV twice daily beginning on day 5 and continuing until at least day 28
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study
Primary
Determine the impact of the use of umbilical cord blood as a source of hematopoietic stem cells for children with life-threatening oncologic hematologic or geneticmetabolic disorders in need of a stem cell transplant
Compare the incidence of graft-versus-host disease in patients receiving cord blood transplants in this study with historical data for unrelated donor stem cell transplants
Compare the incidence of engraftment in patients receiving cord blood transplants in this study with historical data for unrelated donor stem cell transplants
OUTLINE
Preparative therapy Patients are treated on 1 of 4 preparative therapy regimens
Regimen A Patients undergo total body irradiation TBI two times daily on days -7 to -4 Patients receive cyclophosphamide IV over 30-60 minutes on days -3 and -2 and anti-thymocyte globulin ATG IV over at least 6 hours on days -3 to -1
Regimen B patients who do not receive TBI Patients receive oral busulfan 4 times daily on days -8 to -5 and ATG IV over at least 6 hours and melphalan IV over 15-20 minutes on days -4 to -2
Regimen C patients with Fanconis anemia and related disorders Patients undergo TBI on day -6 Patients receive ATG IV over at least 6 hours and methylprednisolone IV on days -5 to -1 and fludarabine IV over 30 minutes and cyclophosphamide IV over 30-60 minutes on days -5 to -2
Regimen D Patients receive oral or IV busulfan 4 times daily on days -9 to -5 ATG IV over at least 6 hours on days -5 to -3 and cyclophosphamide IV over 30-60 minutes on days -5 to -2
Cord blood transplant All patients undergo umbilical cord blood transplantation on day 0
Graft-versus-host disease prophylaxis Patients receive oral or IV cyclosporine twice daily beginning on day -1 Patients also receive methylprednisolone IV twice daily beginning on day 5 and continuing until at least day 28
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PSCI-2003-232 | None | None | None |