Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003336
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
1999-11-01
Brief Title:
Pilot Study Of Unrelated UCB Transplant for Non-Malignant Hematologic Conditions
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Patients With Severe Aplastic Anemia Inborn Errors in Metabolism or Inherited Hematologic Stem Cell Disorders
Status:
COMPLETED
Status Verified Date:
2010-06
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:
RATIONALE Umbilical cord blood transplantation may allow doctors to give higher doses of chemotherapy or radiation therapy and kill more cancer cells
PURPOSE This phase II trial is studying how well umbilical cord blood transplantation works in treating patients with severe aplastic anemia malignant thymoma or myelodysplasia
PURPOSE This phase II trial is studying how well umbilical cord blood transplantation works in treating patients with severe aplastic anemia malignant thymoma or myelodysplasia
Detailed Description:
OBJECTIVES
Determine the rates of durable engraftment in patients with severe aplastic anemia myelodysplastic syndrome inborn errors of metabolism or inherited hematopoietic disorders refractory to medical management who are undergoing high-dose chemoradiotherapy followed by unrelated cord blood UCB transplantation
Evaluate the rate and quality of immunologic reconstitution in this patient population
OUTLINE Patients are stratified according to weight under 45 kg vs over 45 kg
Patients receive high-dose chemotherapy andor radiotherapy as a conditioning regimen beginning 6-9 days before the umbilical cord blood transplant UCBT The regimen varies according to the underlying cause of the anemia but could include busulfan cyclophosphamide or melphalan anti-thymocyte globulin or methylprednisolone andor radiation therapy One day after the conditioning regimen is completed patients receive the UCBT
Patients are followed weekly for 3 months at 6 months then every 6 months for 25 years then annually thereafter
PROJECTED ACCRUAL A total of 4-90 patients will be accrued for this study within 5 years
Determine the rates of durable engraftment in patients with severe aplastic anemia myelodysplastic syndrome inborn errors of metabolism or inherited hematopoietic disorders refractory to medical management who are undergoing high-dose chemoradiotherapy followed by unrelated cord blood UCB transplantation
Evaluate the rate and quality of immunologic reconstitution in this patient population
OUTLINE Patients are stratified according to weight under 45 kg vs over 45 kg
Patients receive high-dose chemotherapy andor radiotherapy as a conditioning regimen beginning 6-9 days before the umbilical cord blood transplant UCBT The regimen varies according to the underlying cause of the anemia but could include busulfan cyclophosphamide or melphalan anti-thymocyte globulin or methylprednisolone andor radiation therapy One day after the conditioning regimen is completed patients receive the UCBT
Patients are followed weekly for 3 months at 6 months then every 6 months for 25 years then annually thereafter
PROJECTED ACCRUAL A total of 4-90 patients will be accrued for this study within 5 years
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 |
|---|---|---|---|
| P30CA043703 | NIH | None | None |
| CASE-CWRU-5Y97 | None | None | None |
| NCI-G98-1431 | None | None | None |
| CASE-5Y97 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA043703 |