Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125606
Status:
TERMINATED
Last Update Posted:
2012-12-18
First Post:
2005-07-26
Brief Title:
Phase 3 Trial for AML Patients in CR2 Comparing 8Gy TBI Fludarabine to Conditioning With TBI 12GyCyclophosphamide
Sponsor:
University Hospital Muenster
Organization:
University Hospital Muenster
Study Overview
Official Title:
Randomized Phase 3 Trial for Patients With AML in CR2 Comparing Total Body Irradiation TBI With 8GyFludarabine to Conditioning With TBI 12GyCyclophosphamide
Status:
TERMINATED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
insufficient patient recruitement
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
For patients with acute myeloid leukemia AML allogeneic hematopoetic stem cell transplantation HSCT is one of the most potent treatment options currently available In order to overcome the high risk of fatal treatment-related complications reduced intensity and nonmyeloablative conditioning regimens for allogeneic HSCT are currently being explored in various hematological malignancies including AML At least for allogeneic HSCT in AML the optimal dose-intensity of preparative regimens for disease control at an acceptable rate of treatment-related lethal complications has not been determined The investigators therefore evaluated reduced intensity myeloablative conditioning with 8 Gy TBI and fludarabine in AML patients considered ineligible for conventional conditioning in a phase 2 trial data published in BLOOD by Stelljes et al 2005 The results suggest that with 8 Gy TBIfludarabine conditioning related and unrelated donor transplants can be performed in AML patients in first or second complete remission CR with a remarkably low 2-year non relapse mortality NRM and satisfactory disease control Based on these data a randomized phase 3 trial for patients with AML in CR2 is currently being conducted by the Cooperative German Transplant Study Group comparing TBI 8 Gyfludarabine to conventionally dosed conditioning with TBI 12 Gycyclophosphamide
Detailed Description:
None
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