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

Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study ID
NCT04589728
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 23, 2021
Status verified
Jul 2025
Primary completion
Sep 8, 2024
Completion
Sep 8, 2024

Study Design

Enrollment
202 participants (actual)

Arms

  • Arm: Study group
    All patients being observed during the study duration.

Primary Outcome Measure

Overall Survival [ Time Frame: 15 months ]

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