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

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status: Enrolling

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Venetoclax plus HMA

Study type: Observational

Funder types: Other

Identifiers

NCT04589728

AML2320

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

104 participants in 1 patient group

Study group

Description:

All patients being observed during the study duration.

Treatment:

Drug: Venetoclax plus HMA