Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia

AML, Adult Clinical Trial

Official title:

Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02986620
• Other study ID #: AML1516
• Status: Completed
• Start date: October 31, 2017
• Est. completion date: March 22, 2021

Study information

• Verified date: September 2021
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a study where there are no interventions planned. Investigators will only collect data already in the patient's history and analyze it. Particularly, we are interested in molecular data from AML patients.

This means that patients will follow their regular diagnostic and clinical practice. The analyses will be conducted according to the routine diagnostic and clinical practice as well and no additional blood withdrawal will be performed.

Description:

The study will be conducted as follows:

1. Retrospective phase clinical and molecular data of patients analyzed for IDH1/2 mutations will be retrospectively collected in the centers that have already introduced IDH1/2 mutational screening in their practice from cases collected according to standard procedure (Ficoll and lysis in RLT buffer).

2. Prospective phase: each participating center already performing IDH1/2 mutational status on samples of their AML patients at diagnosis or relapse - on freshly isolate mononuclear cells from bone marrow and/or peripheral blood using Ficoll density gradient preparation - will prospectively collect the clinical and molecular data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 388
• Est. completion date: March 22, 2021
• Est. primary completion date: March 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable);

• AML patients;

• Age =18;

• IDH mutation test performed at diagnosis or relapse until January 31st, 2019.

Exclusion criteria:

• AML M3 subtype according to the FAB classification;

Related Conditions & MeSH terms

• AML, Adult
• Leukemia, Myeloid, Acute

Intervention

Genetic:
• IDH mutation test performed at diagnosis or relapse until January 31st, 2019.
Observation of the test result.

Locations

Country	Name	City	State
Italy	Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia	Alessandria
Italy	Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto	Bari
Italy	Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia	Bologna
Italy	Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi	Bologna
Italy	Asl Brindisi, Ospedale 'Perrino' - Brindisi - Uo Ematologia	Brindisi
Italy	I.R.S.T. Srl Irccs - Meldola - Sc Oncologia Medica	Meldola
Italy	AOU Policlinico G. Martino	Messina
Italy	Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia	Milano
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano	Milano
Italy	Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia	Milano
Italy	Istituto Europeo Di Oncologia Irccs - Milano - Divisione Di Oncoematologia	Milano
Italy	UO Ematologia _AOU Policlinico di Modena	Modena
Italy	Università degli Studi di Padova - Ematologia ed Immunologia Clinica	Padova
Italy	Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo	Palermo
Italy	AU Policlinico "Paiolo Giaccone"	Palermo
Italy	Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo	Parma
Italy	Sezione di ematologia ed immunologia - Clinica Ospedale S. Maria della Misericordia	Perugia
Italy	Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti	Piacenza
Italy	IFO Istituto Nazionale Tumori Regina Elena	Roma
Italy	Università Cattolica del Sacro Cuore - Policlinico A.Gemelli	Roma
Italy	Università degli Studi - Policlinico di Tor Vergata	Roma
Italy	Università degli Studi - Policlinico Tor Vergata	Rome
Italy	Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia	San Giovanni Rotondo
Italy	Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica	Udine

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with the IDH mutations in AML at initial diagnosis.		At two years from study entry.
Primary	Number of patients with the IDH mutations in AML at relapse.		At three years from study entry.