Low-dose Venetoclax and Azacitidine as Front-line Therapy in Newly Diagnosed AML

Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Study ID
NCT05048615
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Venetoclax 100 MG — DRUG
    Patients will receive oral Venetoclax at a fixed dose of 100mg/day from day 1 to day 21 per cycle for a maximum of 2 cycles.
  • Itraconazole capsule — DRUG
    Patients will receive oral itraconazole at a dose of 100 mg every 12 hours from day 1 to day 21.
  • Azacitidine Injection — DRUG
    Patients will receive a maximum of two cycles of daily subcutaneous Azacitidine at a dose of 75 mg/m2 (maximum 100 mg) from day 1 to day 7.

Study Details

Venetoclax plus azacitidine are effective in treating newly diagnosed AML in patients who cannot recieve intensive chemotherapy. However there is no clinical data rewarding the efficacy and safety of low-dose venetoclax and azacitidine as first-line therapy.

Key Dates

Start date
Jul 26, 2021
Status verified
Jan 2023
Primary completion
Jan 20, 2023
Completion
Jan 20, 2023

Study Design

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

Arms

  • Experimental: Low-dose Ventoclax and oral itraconazol plus subcutaneous Azacitdine
    Patients will recieve Low-dose Venetoclax at a dose of 100mg/day por 21 days, oral itraconazol 100mg every 12 hours, and subcutaneous Azacitidine 75mg/m2 (maximun dose 100mg) daily for seven days. Each cycle duration is 21 days and patients will recieve a maximun of two cycles.

Primary Outcome Measure

Feasibility will be address by obtaining the proportion of patients who need hospitalization [ Time Frame: 1 month ]

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