Prospective and Retrospective Observational Evaluation of Real World Outcome of Unfit AML Patients Treated With the Combination Venetoclax Plus Hypomethylating Agents, Under the Italian Law No.648/96

Acute Myeloid Leukemia Clinical Trial

Official title:

Prospective and Retrospective Observational Evaluation of Real World Outcome of Unfit Patients With Acute Myeloid Leukemia Treated With the Combination Venetoclax Plus Hypomethylating Agents, Under the Italian Law No.648/96

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04589728
• Other study ID #: AML2320
• Status: Recruiting
• Start date: February 23, 2021
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: Paola Fazi
• Phone: 0670390528
• Email: p.fazi[@]gimema.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an retrospective and prospective observational multinstitutional study to evaluate the impact on outcome of the combination of HMA plus venetoclax in AML patients unfit for intensive chemotherapy in a "real-life" scenario. No additional procedures or visits other than those required by normal clinical practice will be required. Patients will be observed for at least 24 months.

Description:

This is an retrospective and prospective observational multinstitutional study to evaluate the impact on outcome of the combination of HMA plus venetoclax in patients with AML unfit for intensive chemotherapy in a "real-life" scenario. At least 104 AML adult patients ineligible for intensive chemotherapy treated with the combination HMA plus venetoclax under the Italian Law No.648/96 by December 2021 will be enrolled. No additional procedures or visits other than those required by normal clinical practice will be required. Patients will be observed for at least 24 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged = 18 years with a diagnosis of previously untreated primary or secondary AML;
• Deemed ineligible for intensive chemotherapy because of age (=75 years), performance status or comorbidities as defined by the treating physicians, according to SIE/SIES/GITMO criteria;
• Eligible to receive the combination HMA plus venetoclax under the Italian Law No.648/96 by December 2021;
• Signed written informed consent according to ICH/EU/GCP and national local laws.

Exclusion Criteria:

• Acute promyelocytic Leukemia;
• Previous first-line treatments for AML;
• Previous treatments with HMA.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Venetoclax plus HMA
patients with AML, ineligible for intensive chemotherapy, treated with the combination of HMA plus venetoclax under the Italian Law N. 648/96.

Locations

Country	Name	City	State
Italy	Asst Papa Giovanni Xxiii - Ospedale Di Bergamo - Sc Ematologia	Bergamo
Italy	Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia	Bologna
Italy	Asst Degli Spedali Civili Di Brescia - Uo Ematologia	Brescia
Italy	Aou Careggi - Firenze - Sod Ematologia	Firenze
Italy	Aou Ospedali Riuniti - Foggia - Uoc Ematologia	Foggia
Italy	Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia	Lecce
Italy	Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia	Mestre
Italy	Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia	Milano
Italy	Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora	Milano
Italy	Istituto Europeo Di Oncologia Irccs - Milano - Divisione Di Oncoematologia	Milano
Italy	Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia	Orbassano
Italy	Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia	Pagani
Italy	Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo	Palermo
Italy	Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo	Perugia
Italy	Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica	Pescara
Italy	Ao Regionale S. Carlo - Potenza - Sic Ematologia	Potenza
Italy	Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali	Roma
Italy	Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche	Salerno
Italy	Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia	Sassari
Italy	Ospedale Di Sassuolo Spa - Ematologia	Sassuolo
Italy	Aou Senese - Uoc Ematologia E Trapianti	Siena
Italy	Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2	Torino
Italy	Asl Di Viterbo, Complesso Ospedaliero Di Belcolle - Uoc Ematologia	Viterbo

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	Overall Survival	Evaluation of Overall Survival in AML patients ineligible for intensive chemotherapy treated with the combination of HMA plus Venetoclax	15 months