Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328237
Status:
UNKNOWN
Last Update Posted:
2006-06-26
First Post:
2006-05-17
Brief Title:
Treatment of Hematologic Malignancies With Single-Unit or Double-Unit Cord Blood Transplantation
Sponsor:
Colorado Blood Cancer Institute
Organization:
Colorado Blood Cancer Institute
Study Overview
Official Title:
Treatment of Hematologic Malignancies With High-Dose Chemo-Radiotherapy Followed by Single-Unit or Double-Unit Cord Blood Transplantation A Phase II Study
Status:
UNKNOWN
Status Verified Date:
2005-11
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:
The purpose of this study is to evaluate the incidence of neutrophil engraftment after transplantation of one or two cord blood units meeting a predetermined total minimum cell dose of 20 x 10 to the seventh total nucleated cell TNCkg
Detailed Description:
This is a non-randomized phase II protocol to evaluate engraftment of cord blood after treatment with myeloablative conditioning of fludarabine total body irradiation and cyclophosphamide All patients will receive tacrolimus and mycophenolate mofetil as prophylaxis for graft-vs-host disease
Conditioning Regimen
Days -10 to -7 Fludarabine 30mgm2day IV
Days -7 to -4 TBI 165 centigray BID
Days -3 to -2 Cyclophosphamide 40mgkgday IV
Day 0 Infusion of Cord Blood Cells
Graft-vs-Host Disease Prophylaxis
Day -1 Start tacrolimus 003mgkgday IV
Day 0 Start MMF 75mgkg IV BID
Conditioning Regimen
Days -10 to -7 Fludarabine 30mgm2day IV
Days -7 to -4 TBI 165 centigray BID
Days -3 to -2 Cyclophosphamide 40mgkgday IV
Day 0 Infusion of Cord Blood Cells
Graft-vs-Host Disease Prophylaxis
Day -1 Start tacrolimus 003mgkgday IV
Day 0 Start MMF 75mgkg IV BID
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