Clinical Trials Logo
  1. Home
  2. Relapsed Adult AML
  3. NCT05193448

A Non-interventional Ambispective Real-world Cohort of rEfractory and reLapsed (R/R) FLT3 Mutated Acute MyEloid Leukemia (AML) Patients Treated With Gilteritinib in FrANCE — ELEGANCE  

Relapsed Adult AML Clinical Trial

Official title:
A Non-interventional Ambispective Real-world Cohort of rEfractory and reLapsed FLT3 Mutated Acute MyEloid Leukemia Patients Treated With Gilteritinib in FrANCE

Clinical Trial Summary

Gilteritinib is available in early access in France through Temporary Authorisation of Use (or ATU program) since March 2019. The ATU program reflects a real-life treatment situation and the related clinical data would help to better understand the benefit/risk profile of gilteritinib and to better document gilteritinib efficacy and safety in patients who received midostaurine in First Line (1L) setting. The main objective is to describe gilteritinib effectiveness in FLT3 (Fms Related Tyrosine Kinase 3) -mutated AML patients in Refractory/Relapsed(R/R) situation treated in the context of early access program to gilteritinib in France through Temporary Authorisation of Use, the so-called ATU program, and the post ATU period from marketing authorisation to launch when reimbursement and price are published.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05193448
Study type Observational [Patient Registry]
Source French Innovative Leukemia Organisation
Contact
Status Completed
Phase
Start date July 5, 2021
Completion date January 31, 2022
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06141304 - Plerixafor Plus Donor Lymphocyte Infusion for Relapsed Acute Leukemia After Allo-HSCT Phase 2
Active, not recruiting NCT05029141 - New Double Epigenetic Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Phase 2
Completed NCT03848754 - Pracinostat and Gemtuzumab Ozogamicin (PraGO) in Patients With Relapsed/Refractory Acute Myeloid Leukemia Phase 1
Not yet recruiting NCT06007911 - Venetoclax-Navitoclax With Cladribine-based Salvage Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia Phase 1
Recruiting NCT04722952 - PD-1 Inhibitor Combined With Azacytidine and Homoharringtonine，Cytarabine, G-CSF for Refractory or Relapsed AML Phase 3
Withdrawn NCT03932318 - Venetoclax, Azacitidine, and Lintuzumab-Ac225 in AML Patients Phase 1/Phase 2
Recruiting NCT06307054 - CLL-1 CAR-NK Cells for Relapsed/Refractory AML Phase 1
Recruiting NCT04310592 - Natural Killer Cell (CYNK-001) Infusions in Adults With AML Phase 1
Recruiting NCT05237258 - Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia N/A
Recruiting NCT04139434 - Dose-Escalation Study of Oral Administration of LP-108 as Monotherapy and in Combination With Azacitidine in Patients With Relapsed or Refractory MDS, CMML, or AML Phase 1
Recruiting NCT03867682 - Venetoclax and Lintuzumab-Ac225 in AML Patients Phase 1/Phase 2
Recruiting NCT06022003 - Study Investigating the Efficacy and Safety of the Addition of Oral-azacitidine to Salvage Treatment by Gilteritinib in Subjects ≥18 Years of Age With Relapsed/Refractory FLT3-mutated Acute Myeloid Leukemia Phase 2
Recruiting NCT03091933 - Antiminor Histocompatibility Complex (MiHA) T Cells for Patients With Relapsed Hematologic Malignancies Following Matched HSCT (Guided Lymphocyte Immunopeptide Derived Expansion) Phase 1/Phase 2
Active, not recruiting NCT04330820 - Trial for Relapsed or Refractory AML Patients Combining Cytarabine and Mitoxantrone With Venetoclax (RELAX) Phase 1/Phase 2
Recruiting NCT05305859 - Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of R/R AML Phase 2
Approved for marketing NCT03245424 - Ivosidenib Expanded Access Program in Relapsed/Refractory AML With an IDH1 Mutation