Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209833
Status:
UNKNOWN
Last Update Posted:
2005-11-18
First Post:
2005-09-13
Brief Title:
Treatment of Adults Aged Up to 60 Years With De Novo Acute Myeloblastic LeukaemiaSecondary AML or RAEB-T
Sponsor:
Hannover Medical School
Organization:
Hannover Medical School
Study Overview
Official Title:
Protocol for the Treatment of Adults Aged 60 Years With De Novo Acute Myeloblastic Leukaemia or Secondary AML or RAEB-T AML 0199 Trial
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
ACTIVE_NOT_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:
This randomized phase IIIII trial investigates the antileukemic activity and toxicity of the FLAG-Ida regimen as a second induction course in patients with acute myeloid leukaemia and bad response to the first induction cycle andor with a high risk karyotype and compares the antileukemic activity and toxicity of high dose cytarabinedaunorubicin vs autologous peripheral blood stem cell transplantation as late consolidation therapy in standard risk patients
Detailed Description:
Assessment of the antileukemic activity and toxicity of the FLAG-Ida regimen as a second induction course in patients with bad response to the first induction cycle andor with a high risk karyotype
Optimization of the late consolidation therapy in standard risk patients SR by a prospective randomized trial comparing a high-dose cytarabinedaunorubicin HD-Ara-CDNR based late consolidation therapy with an autologous peripheral blood stem cell transplantation PBSCT
Assessment of the antileukemic activity of the different treatment elements by monitoring residual disease MRD after induction early and late consolidation by Real-time PCR
Assessment of the prognostic relevance of minimal residual disease by quantification of the residual leukemic burden in haematological remission by Real-time PCR during follow-up
Optimization of the late consolidation therapy in standard risk patients SR by a prospective randomized trial comparing a high-dose cytarabinedaunorubicin HD-Ara-CDNR based late consolidation therapy with an autologous peripheral blood stem cell transplantation PBSCT
Assessment of the antileukemic activity of the different treatment elements by monitoring residual disease MRD after induction early and late consolidation by Real-time PCR
Assessment of the prognostic relevance of minimal residual disease by quantification of the residual leukemic burden in haematological remission by Real-time PCR during follow-up
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