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Completed

NCT Number: NCT05048615

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

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.

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Key information

Conditions

AML Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Andres Gomez

Monterrey, Nuevo León, 64710, Mexico

About this study

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. This phase 2 clinical trial will explore the efficacy and safety of low-dose venetoclax (100mg /day/21 days) and a fixed dose of azacitidine (75mg/m2, maximun dose 100mg, SC for seven consecutive days) for a maximun of two cycles.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 years
  • Both genders
  • Diagnosis of non-m3 AML by the WHO 2016 diagnostic criteria
  • Patients eligible and not eligible for transplant
  • AML secondary to treatment or associated to myelodisplasia

Exclusion criteria

  • AML with PML/RAR-alfa translocation t(15;17)
  • Central nervous system involvement
  • Poor functional status (ECOG>2)
  • Organic dysfunction (Marshall score ≥2)
  • Active infection
  • Use of other CYP3A4 inhibitors
  • Pregnancy
  • GFR <30 ml/min/1.72m2

Treatment and study plan

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.

Other names: Venclexta

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.

Other names: Vidaza

Primary outcomes

  1. Feasibility will be address by obtaining the proportion of patients who need hospitalization

    Time frame: 1 month

    If therapy is feasible >50% of patients will recieve their first cycle of treatment without hospitalization

  2. Safety will be defined by the number of patients deceased before 14 days of initiating treatment

    Time frame: 2 weeks

    If therapy is safe then <10% of patients will die in the first 14 days of treatment

  3. Safety will be defined by the number of patients deceased before 30 days of initiating treatment

    Time frame: 1 month

    If therapy is safe then <20% of patients will die in the first 30 days of treatment

Secondary outcomes

  1. Efficacy will be achieved if the overall response rate is similar to standard of care (7+3)

    Time frame: 2 months

    If the therapy is effective then overall response rates will be similar to those reported with standard of care (7+3)

Sponsors and collaborators

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Other

Registry information

Official study title

Efficacy and Safety of Ambulatory Low-dose Venetoclax and Azacitidne as First Line Therapy in Newly Diagnosed AML: a Pilot Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 17, 2021
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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