Venetoclax Plus Azacitidine Versus Intensive Chemotherapy for Fit Patients With Newly Diagnosed NPM1 Mutated AML

Sponsor
Technische Universität Dresden
Study ID
NCT05904106
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax plus Azacitidine — DRUG
    Induction cycle 1: 100 mg venetoclax p.o. on day 1; 200 mg venetoclax p.o. on day 2; 400 mg venetoclax p.o. on days 3-28; 75 mg/m\^2 azacitidine s.c. on days 1-7 Induction cycles 2-3: 400 mg venetoclax p.o. on days 1-28; 75 mg/m\^2 azacitidine s.c. on days 1-7 Postremission cycles 1-9: 400 mg venetoclax p.o. on days 1-28; 75 mg/m\^2 azacitidine s.c. on days 1-7
  • standard of care chemotherapy plus gemtuzumab ozogamicin — DRUG
    Induction cycle 1: 200 mg/m\^2 cytarabine cont inf i.v. on days 1-7; 60 mg/m\^2 daunorubicin i.v. on days 3-5; 3 mg/m\^2 (max 1 vial) gemtuzumab ozogamicin i.v. on days 1+4+7 Induction cycle 2 (patients not in remission, moderate or non-responders): 3000/1000 mg/m\^2 cytarabine i.v. BID on days 1-3; 10 mg/m\^2 mitoxantrone i.v. on days 3-5 Postremission cycles 1-3: 3000/1000 mg/m\^2 cytarabine i.v. BID on days 1-3

Study Details

This phase II clinical trial evaluates the efficacy and tolerability of the non-intensive treatment with venetoclax and the hypomethylating agent azacitidine as compared to the standard of care chemotherapy plus gemtuzumab ozogamicin in newly diagnosed NPM1 mutated AML patients fit for intensive chemotherapy.

Key Dates

Start date
Apr 7, 2024
Status verified
Nov 2024
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
146 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ven+Aza arm
    non-intensive treatment: venetoclax plus azacitidine
  • Active Comparator: SOC arm
    standard of care treatment: intensive chemotherapy plus gemtuzumab ozogamicin

Primary Outcome Measure

modified event-free survival (mEFS) [ Time Frame: time interval from date of randomization until either primary treatment failure or hematologic relapse or molecular failure or death, whichever occurs first ]

Central Contacts

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