Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00180102
Status:
COMPLETED
Last Update Posted:
2009-12-24
First Post:
2005-09-12
Brief Title:
AML2003 - Standard-Therapy vs Intensified Therapy for Adult Acute Myeloid Leukemia Patients 60 Years
Sponsor:
Technische Universität Dresden
Organization:
Technische Universität Dresden
Study Overview
Official Title:
AML2003 - Randomized Comparison Between Standard-Therapy and Intensified Therapy for Adult Acute Myeloid Leukemia Patients 60 Years A Prospective Randomized Multi-center Therapy-Optimizing-Study
Status:
COMPLETED
Status Verified Date:
2009-12
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:
AML2003 is a prospective randomized trial to investigate the value of early allogeneic stem cell transplantation in aplasia after induction therapy for high risk patients with acute myeloid leukemia
Detailed Description:
AML2003 is a prospective randomized trial to investigate the value of early allogeneic stem cell transplantation in aplasia after induction therapy for high risk patients with acute myeloid leukemia A rapid analysis of risk-factors cytogenetics FLT3 status clearance of blasts after first induction and the donor situation is of utmost importance For this fast search diagnostic which is accomplished in all enclosed patients significant resources are provided to take the load off the participating centers Furthermore the relevance of autologous transplantation and the benefit of additional substances within the postremission therapy such as m-AMSA or mitoxantrone will be investigated There is an up-front randomisation in four therapy arms with two cross-classifying factors of two stages intensified vs standard therapy and Ara C vs Ara C mitoxantrone m-AMSA Thus the intergroup treatment schedule of the German Competence Network is integrated into the AML2003 study as a central element and 25 of the patients are treated accordingly In the intensified therapy arms a risk-adapted and priority-based therapy is implemented including early allogeneic and consolidating autologous stem cell transplantation respectively In addition to the clinical questions a detailed concomitant research program was initiated for the AML2003 study to get a better view of the heterogeneity of AML and to open new ways for custom-made therapies
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