Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-28 @ 4:30 AM
Study NCT ID:
NCT00909168
Status:
COMPLETED
Last Update Posted:
2014-05-06
First Post:
2009-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
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 (IDAC+IDA) +/- one course of high dose AraC (HDAC)
* INTENSIFICATION: Allo-BMT, ASCT
* MAINTENANCE: AraC
a) Primary endpoints:
* Feasibility, Efficacy (CR+PR 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 (IDAC+IDA) +/- one course of high dose AraC (HDAC)
* INTENSIFICATION: Allo-BMT, ASCT
* MAINTENANCE: AraC
a) Primary endpoints:
* Feasibility, Efficacy (CR+PR 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:
True
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?: