Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005893
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-06-02
Brief Title:
Study of Allogeneic Bone Marrow Transplantation Using Matched Related Donors in Patients With Nonmalignant Hematologic Disorders
Sponsor:
Fairview University Medical Center
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-07
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:
OBJECTIVES I Determine the efficacy of bone marrow transplantation using matched related donors in patients with nonmalignant hematologic disorders
II Determine the quality of life absence of adverse effects eg graft versus host disease and B cell lymphoproliferative disease and completeness of recovery of their underlying condition in these patients with this treatment regimen
II Determine the quality of life absence of adverse effects eg graft versus host disease and B cell lymphoproliferative disease and completeness of recovery of their underlying condition in these patients with this treatment regimen
Detailed Description:
PROTOCOL OUTLINE Patients receive IV or oral busulfan every 6 hours on days -9 to -6 cyclophosphamide IV on days -5 to -2 anti-thymocyte globulin IV on days -4 to -2 and allogeneic bone marrow transplantation BMT on day 0
Patients with class 3 thalassemia liver edge greater than 2 cm below costal margin a history of inconsistent chelation and portal fibrosis receive a less intensive conditioning regimen consisting of oral busulfan every 6 hours on days -7 to -4 anti-thymocyte globulin IV on days -5 to -1 and days 1-5 cyclophosphamide IV on days -3 to -2 and allogeneic BMT on day 0
Patients are followed at day 28 and then at 3 6 12 and 24 months
Patients with class 3 thalassemia liver edge greater than 2 cm below costal margin a history of inconsistent chelation and portal fibrosis receive a less intensive conditioning regimen consisting of oral busulfan every 6 hours on days -7 to -4 anti-thymocyte globulin IV on days -5 to -1 and days 1-5 cyclophosphamide IV on days -3 to -2 and allogeneic BMT on day 0
Patients are followed at day 28 and then at 3 6 12 and 24 months
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 |
|---|---|---|---|
| UMN-MT-1994-18 | None | None | None |
| UMN-MT-9418 | None | None | None |