Ignite Creation Date:
2024-05-05 @ 9:31 PM
Last Modification Date:
2024-10-26 @ 10:06 AM
Study NCT ID:
NCT00909168
Status:
COMPLETED
Last Update Posted:
2014-05-06
First Post:
2009-05-26
Brief Title:
Induction Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia AML
Sponsor:
University Hospital Udine Italy
Organization:
University Hospital Udine Italy
Study Overview
Official Title:
Induction Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia AML
Status:
COMPLETED
Status Verified Date:
2014-05
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:
MYFLAI07
Brief Summary:
This is a prospective open non-randomized non-controlled phase II clinical trial for treatment of newly diagnosed AML patients younger than 66 years
Trial is based on
INDUCTION FLAI Gemtuzumab-Ozogamicin FLAI-GO
CONSOLIDATION Intermediate dose AraC IDA IDACIDA - one course of high dose AraC HDAC
INTENSIFICATION Allo-BMT ASCT
MAINTENANCE AraC
a Primary endpoints
Feasibility Efficacy CRPR rate and Toxicity of FLAI Gemtuzumab-Ozogamicin
RFS DFS and OS
b Secondary endpoints
Evaluation of Minimal Residual Disease by WT1 and other biologic markers expression and monitoring
Evaluation of prognostic clinical relevance of biological features at onset
Feasibility and outcome of consolidation with BMT
Trial is based on
INDUCTION FLAI Gemtuzumab-Ozogamicin FLAI-GO
CONSOLIDATION Intermediate dose AraC IDA IDACIDA - one course of high dose AraC HDAC
INTENSIFICATION Allo-BMT ASCT
MAINTENANCE AraC
a Primary endpoints
Feasibility Efficacy CRPR rate and Toxicity of FLAI Gemtuzumab-Ozogamicin
RFS DFS and OS
b Secondary endpoints
Evaluation of Minimal Residual Disease by WT1 and other biologic markers expression and monitoring
Evaluation of prognostic clinical relevance of biological features at onset
Feasibility and outcome of consolidation with BMT
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