Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354419
Status:
TERMINATED
Last Update Posted:
2011-01-05
First Post:
2006-07-19
Brief Title:
Cyclophosphamide Antithymocyte Globulin and Total-Body Irradiation in Treating Patients With Severe Aplastic Anemia Undergoing Umbilical Cord Blood Transplant
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Dose Finding Study of Total Body Irradiation for Conditioning Patients With Severe Aplastic Anemia Transplanted With Umbilical Cord Blood
Status:
TERMINATED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Giving chemotherapy and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of abnormal cells It also helps stop the patients immune system from rejecting the donors stem cells When the healthy stem cells from a donor are infused into the patient they may help the patients bone marrow make stem cells red blood cells white blood cells and platelets Sometimes the transplanted cells from a donor can make an immune response against the bodys normal cells Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening
PURPOSE This phase I trial is studying the side effects and best dose of total-body irradiation when given together with cyclophosphamide and antithymocyte globulin in treating patients with severe aplastic anemia undergoing umbilical cord blood transplant
PURPOSE This phase I trial is studying the side effects and best dose of total-body irradiation when given together with cyclophosphamide and antithymocyte globulin in treating patients with severe aplastic anemia undergoing umbilical cord blood transplant
Detailed Description:
OBJECTIVES
I The objective of this study is to determine the lowest dose of total body irradiation combined with cyclophosphamide and antithymocyte globulin that will achieve sustained engraftment in patients with severe aplastic anemia transplanted with unrelated umbilical cord blood
OUTLINE This is a dose-escalation study of total-body irradiation TBI
MYELOABLATIVE CONDITIONING REGIMEN Patients receive cyclophosphamide IV on days -7 to -4 -6 to -3 or -5 to -2 and antithymocyte globulin IV on days -6 to -4 -5 to -3 or -4 to -2
TBI Patients undergo TBI twice daily on days -3 -2 andor -1
UMBILICAL CORD BLOOD TRANSPLANTATION UCBT Patients undergo UCBT on day 0 Patients receive filgrastim G-CSF IV or subcutaneously beginning on day 1 and continuing until blood counts recover
GRAFT-VS-HOST DISEASE GVHD PROPHYLAXIS Patients receive cyclosporine IV or orally twice daily for patients 6 years of age or 3 times daily for patients 6 years of age on days -1 to 180 and mycophenolate mofetil IV or orally twice daily for patients 50 kg or 3 times daily for patients 50 kg beginning 4 hours after UCBT and continuing until approximately day 0
After completion of study therapy patients are followed periodically
I The objective of this study is to determine the lowest dose of total body irradiation combined with cyclophosphamide and antithymocyte globulin that will achieve sustained engraftment in patients with severe aplastic anemia transplanted with unrelated umbilical cord blood
OUTLINE This is a dose-escalation study of total-body irradiation TBI
MYELOABLATIVE CONDITIONING REGIMEN Patients receive cyclophosphamide IV on days -7 to -4 -6 to -3 or -5 to -2 and antithymocyte globulin IV on days -6 to -4 -5 to -3 or -4 to -2
TBI Patients undergo TBI twice daily on days -3 -2 andor -1
UMBILICAL CORD BLOOD TRANSPLANTATION UCBT Patients undergo UCBT on day 0 Patients receive filgrastim G-CSF IV or subcutaneously beginning on day 1 and continuing until blood counts recover
GRAFT-VS-HOST DISEASE GVHD PROPHYLAXIS Patients receive cyclosporine IV or orally twice daily for patients 6 years of age or 3 times daily for patients 6 years of age on days -1 to 180 and mycophenolate mofetil IV or orally twice daily for patients 50 kg or 3 times daily for patients 50 kg beginning 4 hours after UCBT and continuing until approximately day 0
After completion of study therapy patients are followed periodically
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 |
|---|---|---|---|
| NCI-2010-00191 | None | None | None |