A Multicenter, Prospective, Randomized Controlled Study of the Standard 3+7 Regimen Versus Venetoclax Combined With CACAG Regimen in Newly Diagnosed Adult Patients With Intermediate- and High-risk Acute Myeloid Leukemia
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to compare the efficacy and safety of venetoclax combined with the CACAG regimen with the traditional 3+7 regimen in the treatment of newly diagnosed intermediate- or high-risk acute myeloid leukemia (AML).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 75
Healthy Volunteers: f
View:
• Age 14 to 75 years (no gender limitation) Newly diagnosed with intermediate- or high-risk AML (excluding M3) Liver function: ALT and AST ≤ 2.5 times upper limit of normal; bilirubin ≤ 2 times upper limit of normal Renal function: creatinine ≤ upper limit of normal No uncontrolled infections, organ dysfunction, or severe mental illness ECOG performance status score of 0-2 and predicted survival ≥ 4 months No severe allergic constitution
Locations
Other Locations
China
Chinese PLA General Hospital
RECRUITING
Beijing
Time Frame
Start Date: 2024-04-18
Estimated Completion Date: 2026-10-18
Participants
Target number of participants: 160
Treatments
Experimental: Venetoclax Combined With CACAG Regimen
The CACAG+Venetoclax regimen has a total treatment period of 1 week, with a treatment cycle every 4 weeks, and a total of 1 course of treatment.~Chidamide: 30 mg, twice a week, for a total of 2 administrations; Azacitidine: 75 mg/m\^2 from day 1 to day 7; Cytarabine (Ara-C): 75-100 mg/m\^2 every 12 hours from day 1 to day 7; Aclarubicin: 20 mg/m\^2 on days 1, 3, and 5; Recombinant human granulocyte colony-stimulating factor (G-CSF): 300 μg/day, continued until neutrophil recovery and white blood cell count is ≥20,000/μL; Venetoclax: 100 mg on day 1, 200 mg on day 2, 400 mg from day 3 to day 14, when used in combination with azole drugs, the dosage is reduced to 100 mg/day.
Active_comparator: 3+7 Regimen
Idarubicin+cytarabine(IA) regimen or daunorubicin+cytarabine(DA) regimen for newly diagnosed AML.Recipients were randomized and those entering this group received IA or DA induction chemotherapy. With the IA regimen,recipients received idarubicin(8-10 mg/m2) for three days and cytarabine(75-100 mg/m2, every 12 hrs) for seven days. With the DA regimen,recipients received daunorubicin(60 mg/m2)for three days and cytarabine(75-100 mg/m2,every 12 hrs)for seven days.
Related Therapeutic Areas
Sponsors
Collaborators: 940 Hospital of the People's Liberation Army Joint Logistic Support Force, The 960th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army, Yantai Yuhuangding Hospital, the First People's Hospital of Jining, First Affiliated Hospital of Harbin Medical University, Chinese People's Liberation Army Air Force General Hospital, The General Hospital of Western Theater Command
Leads: Chinese PLA General Hospital