Ignite Creation Date:
2024-05-06 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03547258
Status:
UNKNOWN
Last Update Posted:
2020-04-21
First Post:
2018-05-11
Brief Title:
Italian Non-Interventional Study of FLT3 Mutated AML Patients
Sponsor:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Organization:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Study Overview
Official Title:
Italian Non-Interventional Study of FMS-like Tyrosine Kinase FLT3 Mutated Acute Myeloid Leukemia AML Patients
Status:
UNKNOWN
Status Verified Date:
2020-04
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:
FLAM
Brief Summary:
This is an observational study involving a retrospective and prospective collection of clinical and molecular data regarding patients with AML with FLT3 mutations
Detailed Description:
This is an observational study involving a retrospective and prospective collection of clinical and molecular data Patients will follow their regular diagnostic and clinical practice Thus no additional procedureblood withdrawal will be performed
The study will be conducted as follows
1 Retrospective phase clinical and molecular data of AML patients with FLT3 mutations detected at diagnosis or at any refractoryrelapse state will be collected
2 Prospective phase clinical and molecular data of each new FLT3 AML patient identified in participating centers at diagnosis or at any refractoryrelapse state will be collected prospectively Every effort will be done to include all consecutive patients in order to avoid selection bias
For patients with a mutation found at the time of disease relapse any effort will be done to collect all the clinical and molecular information since the time of diagnosis
The Primary objective of this study is to analyze how FLT3 mutational status evolve during the management of the disease looking at the percentage of patients with no FLT3 mutations at diagnosis who relapse with a new FLT3 mutation detected and the percentage of FLT3 positive AML patients that after having obtained a Complete Remission relapse with FLT3 negative
The secondary objective of the study is to investigate the association between different FLT3 mutations and the clinical molecular and biological information
The study will be conducted as follows
1 Retrospective phase clinical and molecular data of AML patients with FLT3 mutations detected at diagnosis or at any refractoryrelapse state will be collected
2 Prospective phase clinical and molecular data of each new FLT3 AML patient identified in participating centers at diagnosis or at any refractoryrelapse state will be collected prospectively Every effort will be done to include all consecutive patients in order to avoid selection bias
For patients with a mutation found at the time of disease relapse any effort will be done to collect all the clinical and molecular information since the time of diagnosis
The Primary objective of this study is to analyze how FLT3 mutational status evolve during the management of the disease looking at the percentage of patients with no FLT3 mutations at diagnosis who relapse with a new FLT3 mutation detected and the percentage of FLT3 positive AML patients that after having obtained a Complete Remission relapse with FLT3 negative
The secondary objective of the study is to investigate the association between different FLT3 mutations and the clinical molecular and biological information
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None