Venetoclax Add in Combination With Fludarabine, Cyratabine and Idarubicine in Induction for Acute Myelid Leukemia

Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study ID
NCT03455504
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Venetoclax add in combination with fludarabine, cyratabine and idarubicine

Study Details

This study will test the effectiveness and safety of Venetoclax in combination with standard induction regimen for patients with acute leukemia and poor prognosis.

Key Dates

First listed
Mar 6, 2018
Start date
Oct 26, 2018
Status verified
Jul 2026
Primary completion
Jul 21, 2025
Completion
Jul 15, 2026

Study Design

Enrollment
124 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    FLAI + V400 mg
  • Experimental: Cohort 2
    FLAI + V600 mg

Primary Outcome Measure

Number of patients achieving complete response (CR) after course 1 or course 2 if course 2 is administered (CR + CRi + CRp) [ Time Frame: At 24 months from study entry ]

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