Trial in AML Secondary to MPNs Patients, Unfit for Intensive Chemotherapy, Investigating a Treatment Combination Including Decitabine and Venetoclax

Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study ID
NCT04763928
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Venetoclax+Decitabine — DRUG
    Patients will receive treatment with a combination of decitabine and venetoclax as follows: * Decitabine 20 mg/sqm intravenously on days 1 to 5 of 28-days courses * Venetoclax 400 mg per day orally on days 1 to 28 of 28-days courses; a dose escalation period is provided at first cycle (ramp-up) in which VEN is administered as follows: 100 mg on day -2, 200 mg on day -1, and 400 mg on day 1, a dose that is continued subsequently, daily, for 28-day cycles. In case of achievement of response, the treatment will be continued until disease progression or death by other causes.

Study Details

Prospective, multi-center, intervention, open clinical trial for the treatment of AML secondary to MPN in patients unfit for intensive chemotherapy investigating a combination regimen including VEN and DEC.

Key Dates

Start date
Dec 3, 2021
Status verified
Nov 2024
Primary completion
Oct 25, 2024
Completion
Apr 30, 2026

Study Design

Enrollment
101 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: VenDec
    Patients will receive a combination of VENETOCLAX (400 mg per day orally on days 1 to 28 of 28-days courses) and DECITABINE (20 mg/sqm intravenously on days 1 to 5 of 28-days courses)

Primary Outcome Measure

Efficacy of VEN-DEC regimen (event free survival) [ Time Frame: at 1 year ]

Related Studies