An observational study in AML, FLT3-ITD Mutation and FLT3-TKD Mutation, sponsored by Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori. Status unknown at 33 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-21.
Sponsored by Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori · Observational
This is an observational study involving a retrospective and prospective collection of clinical and molecular data regarding patients with AML with FLT3+ mutations
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 procedure/blood withdrawal will be performed.
The study will be conducted as follows:
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.
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori is the lead sponsor of 25 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
All consecutive patient with FLT3 mutated AML documented at diagnosis or at the time of relapse/refractory state treated in the participating center. With regards to the retrospective collection, data from the eligible and acconsenting patients will be retrieved since 2012, that is, when the evaluation of FLT3 mutation was almost routine in the centers considered in the study.
Exclusion criteria:
Clinical and Molecular data collection of AML Patients with FLT3 mutations (ITD or TKD)
Genetic: Clinical and Molecular data collection
Clinical and Molecular data collection at diagnosis, during treatment and at each relapse
percentage of patients FLT3 negative at diagnosis who relapse FLT3 positive;
description of how the FLT3 mutational status changes during the course and management of the disease
Time frame: up to 24 months
percentage of patients FLT3 positive at diagnosis who relapse FLT3 negative
description of how the FLT3 mutational status changes during the course and management of the disease
Time frame: up to 24 months
objective overall response rate (ORR)
the objective overall response rate (ORR) defined as the proportion of patients with a partial or response (CR, CRi, CRp) response, to initial treatment and in case of salvage;
Time frame: up to 24 months
disease-free survival (DFS)
disease-free survival (DFS) after first CR and after CR2/CR3, if applicable, defined as the time since CR (or CR2 or CR3) to disease relapse or death for any cause, whichever occurs first.
Time frame: up to 24 months
overall survival (OS)
overall survival (OS) defined as the time since date of diagnosis until death for any cause or the last available patient contact.
Time frame: up to 24 months
Percentage of AML patients with specific types of FLT3 mutations
Percentage of AML patients with specific types of FLT3 mutations, at initial diagnosis and at disease relapse
Time frame: up to 24 months
distribution of specific FLT3 mutations in AML patients
distribution of specific FLT3 mutations in AML patients according to: age, WBC, LDH, cytogenetics, NPM1, CEBPA alterations, IDH1/2, tp53, DNMT3A, secondary vs de novo AML;
Time frame: up to 24 months
frequency of the different methods used to evaluate (Minimal residual disease) MRD
the frequency of the different methods used to evaluate MRD such as, wt1 ratio or the fusion transcript level by Reverse transcription polymerase chain reaction (RT-PCR); percentage of patients performing FLT3 ITD analysis by Next Generation Sequencing (NGS);
Time frame: up to 24 months
FLT3-ITD allelic ratio
FLT3-ITD allelic ratio defined as the ratio of the area under the curve of mutant and wild type alleles (mutant/totalFLT3) obtained after Fragment analysis for FLT3-ITD;
Time frame: up to 24 months
transplantation percentage
percentage of FLT3 mutated AML patients undergoing transplantation
Time frame: up to 24 months
evaluation of modifications in terms of quality of life (QoL) of patients with FLT3 mutated AML
scores for each patient and each scale as well as a summary QoL score will be computed according to the EORTC QLQ-C3 (quality of life questionnaire) manual
Time frame: up to 24 months
retrospective collection of surrogate measures of QoL
the surrogate measures of QoL , as the number and days of hospitalizations per patient, number of clinical visits per patient, number of access in Day Hospital and Emergency Care Units per patient, and the use of antalgic drugs and neuro-active drugs, will be expressed in terms of mean values per patient or through proportions
Time frame: up to 24 months
This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori