Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199147
Status:
UNKNOWN
Last Update Posted:
2005-10-26
First Post:
2005-09-14
Brief Title:
Efficacy of G-CSF-Priming in Elderly AML Patients
Sponsor:
Johann Wolfgang Goethe University Hospital
Organization:
Johann Wolfgang Goethe University Hospital
Study Overview
Official Title:
Treatment of Elderly Patients 60 Years With Acute Myeloblastic Leukemia or Advanced MDS RAEB-T An Open Randomized Study to Test the Efficacy of G-CSF-Priming and a Feasibility Trial of Dose-Reduced Allogeneic Transplantation and of Autologous Stem Cell Transplantation
Status:
UNKNOWN
Status Verified Date:
2005-09
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:
Aim of the study is to compare the efficacy of intensive induction therapy with Cytarabine Idarubicin and Etoposide IdAV given in parallel with G-CSF priming and followed by G-CSF versus the same IdAV chemotherapy only followed by G-CSF without priming in elderly patients with de novo AML secondary AML and advanced MDS Moreover the ability to mobilize sufficient numbers of peripheral blood stem cells PBSC for autologous PBSC transplantation after consolidation therapy with dose-reduced FLAG-Ida chemotherapy followed by G-CSF will be evaluated
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