Status and phase
Conditions
Treatments
About
The goal of this clinical research study is to evaluate the safety and efficacy of Azacytidine in combination with Venetoclax in patients with newly diagnosed fit acute myeloid leukemia.
Full description
The Study Drug:
Azacitidine is a DNA Demethylated drug, which is approvd for treatment of elderly AML patients Venetoclax targets the anti-apoptotic protein Bcl-2 and the process of oxidative phosphorylation to induce apoptosis of leukemia cells and exhibits anti-tumor activity.
Study Group:
single arm: AZA plus Venetoclax
Study Drug Administration:
Each course is 28 days long. Venetoclax is taken once daily by oral. The doses of Venetoclax is 100 mg on Day 1, 200 mg on Day 2, reaching a target dose of 400 mg on Day 3 and continuing through Day 28. If concomitantly receiving azoles, the dose of Venetoclax will be adjusted according to the instructions. Azacitidine is taken 75mg/m2 on Days 1-7. Subjects would received 1-2 cycles induction therapy. Once get remission, subjects would received the same indution therapy of middle to high dose of cytarabine based chemotherapy at the discretion of the physician for consolidation. Allo-HSCT is suggested for subjects with the moderate to adverse ELN2017 risk.
Study Visit:
After treatment, relapse and survival will be followed monthly by telephone, on-site visits, and/or study medical records for up to two years (calculated from the first day of induction therapy); Thereafter follow-up every 3 months for one year.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
1.Age 45 to 65 years old,both male and female
2.Be able to understand and sign informed consent
3.Untreated AML patients (non-APL) diagnosed according to the 2016 World Health Organization (WHO) classification and diagnostic criteria for acute myeloid leukemia
4.Patients with an ECOG performance status 0,1,2 or 3
5.Expected survival time≥3 months
6.Laboratory indicators meet the following standards:
Exclusion criteria
1.patients participating in other interventional or observational clinical studies currently
2.Patients has a history of myeloproliferative neoplasm [MPN]
3.Patients with acute promyelocytic leukemia
4.Active CNS involvement in patients with acute myeloid leukemia
5.Patients with active hepatitis B or C, HIV infection before enrollment
6.Cardiovascular status of patients evaluate by NYHA classification method > 2
7.Patients have chronic respiratory disease requiring continuous oxygen treatment, or any sitiuation investigator believes will adversely affect this study (including renal, neurological, psychiatric, endocrine, metabolic, immune, hepatic, cardiovascular disease and known history of allergy to any study drug)
8.Patients suffering from malabsorption syndrome or other diseases that prevent the enteral route of administration
9.patients present with an uncontrolled systemic infection (viral, bacterial, or fungal)
10.Patients with a history of other malignancies within 2 years before enrollment, except for the following cases:
Primary purpose
Allocation
Interventional model
Masking
40 participants in 1 patient group
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Central trial contact
Xiaonan Lin, Bachelor; Huang Rui, Doctor
Data sourced from clinicaltrials.gov
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