Low-dose Venetoclax and Azacitidine as Front-line Therapy in Newly Diagnosed AML
Sponsored by Hospital Universitario Dr. Jose E. Gonzalez
About this trial
Last updated 2 years ago
Study ID
HE21-00014
Status
Completed
Type
Interventional
Phase
Phase 2
Placebo
No
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 2 years ago
What is this trial about?
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.
What are the participation requirements?
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