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

Hospital Universitario Dr. Jose E. Gonzalez15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

AML

Interventions

Venetoclax 100 MGDRUG

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 capsuleDRUG

Patients will receive oral itraconazole at a dose of 100 mg every 12 hours from day 1 to day 21.

Azacitidine InjectionDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age \>18 years 2. Both genders 3. Diagnosis of non-m3 AML by the WHO 2016 diagnostic criteria 4. Patients eligible and not eligible for transplant 5. AML secondary to treatment or associated to myelodisplasia Exclusion Criteria: 1. AML with PML/RAR-alfa translocation t(15;17) 2. Central nervous system involvement 3. Poor functional status (ECOG\>2) 4. Organic dysfunction (Marshall score ≥2) 5. Active infection 6. Use of other CYP3A4 inhibitors 7. Pregnancy 8. GFR \<30 ml/min/1.72m2

Locations (1)

Andres Gomez

Monterrey, Nuevo León, Mexico

Outcomes

Primary Outcomes

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

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

Time frame: 1 month

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

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

Time frame: 2 weeks

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

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

Time frame: 1 month

Secondary Outcomes

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

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

Time frame: 2 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.