Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00150878
Status:
TERMINATED
Last Update Posted:
2013-06-20
First Post:
2005-09-06
Brief Title:
Standard vs Reduced-Intensity Conditioning in Patients With Acute Myeloid Leukemia in First Remission
Sponsor:
University Hospital Carl Gustav Carus
Organization:
University Hospital Carl Gustav Carus
Study Overview
Official Title:
Randomized Phase III Comparison of 12 Gy TBI and Cyclophosphamide 120 mgkg With Fludarabine 120 mgSqm and 8 Gy TBI Before Allogeneic Transplantation in Patients With Acute Myeloid Leukemia in First Remission
Status:
TERMINATED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insurance coverage reached
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary goal of the study is to show that the treatment-related mortality of allogeneic hematopoietic stem cell transplantation an be significantly reduced by using a combination of 8 Gy total-body-irradiation and fludarabine in comparison to the conventional combination of 12 Gy TBI and 120 mgkg Cyclophosphamide
Detailed Description:
Transplant-related deaths because of extramedullary toxicity and graft-versus host disease remain the major causes for treatment-failure in patients with AMl receiving allogeneic hematopoietic stem cell transplantation
In phase II study M Stelljes and coworkers could show that a reduced dose of total-body- irradiation and fludarabine can be safely used in patients with AML at various disease stages The best results could be achieved in patients who had been in complete remission by the time of inclusion
Therefore this prospective trial was initiated to compare the new conditioning regimen with the standard regimen of 12 Gy TBICyclophosphamide 120 mgkg in patients ith AML in first remission
After having achieved complete remission and giving informed consent patients are stratified according to marrow cytogenetics age and type of induction therapy and subsequently randomized to receive on of the mentioned conditioning therapies
The primary end-point will be non-relapse mortality The hypothesis would be that the one-year mortality can be reduced from 25 to 15 Given a power of 08 and a first-error of 5 252 patients will have to be randomized
Secondary endpoints include
3 year overall-and disease-free survival Rate of grade II-IV acute GvHD Rate of grade 3-4 extramedullary toxicity
In phase II study M Stelljes and coworkers could show that a reduced dose of total-body- irradiation and fludarabine can be safely used in patients with AML at various disease stages The best results could be achieved in patients who had been in complete remission by the time of inclusion
Therefore this prospective trial was initiated to compare the new conditioning regimen with the standard regimen of 12 Gy TBICyclophosphamide 120 mgkg in patients ith AML in first remission
After having achieved complete remission and giving informed consent patients are stratified according to marrow cytogenetics age and type of induction therapy and subsequently randomized to receive on of the mentioned conditioning therapies
The primary end-point will be non-relapse mortality The hypothesis would be that the one-year mortality can be reduced from 25 to 15 Given a power of 08 and a first-error of 5 252 patients will have to be randomized
Secondary endpoints include
3 year overall-and disease-free survival Rate of grade II-IV acute GvHD Rate of grade 3-4 extramedullary toxicity
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