Phase II Trial of Venetoclax in Combination With Azacitidine and CAG as Induction Therapy in Patients With Refractory/Relapse Acute Myeloid Leukemia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study aims to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine and CAG as induction regimen in Patients with Refreactory/Relapse Acute Myeloid Leukemia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Patients ≥ 18 years old and ≤ 65 years old

• Refractory/Relapse AML patients according to 2016 World Health Organization (WHO) classification;

• Eastern Cooperative Oncology Group (ECOG) Performance status score less than 3;

• Liver function: Total bilirubin ≦2 upper limit of normal (ULN); aspartate aminotransferase (AST) ≦3 ULN; alanine aminotransferase (ALT)≦3 ULN

• Renal function:Ccr(Creatinine Clearance Rate) ≧30 ml/min; Scr (serum creatinine) ≦2 ULN

• Heart function: left ventricular ejection fraction ≧45%

• Patients must participate in this clinical trial voluntarily and sign an informed consent form.

Locations
Other Locations
China
Department of Hematology,920th Hospital of Joint Logistic Support Force of People's Liberation
RECRUITING
Kunming
Time Frame
Start Date: 2023-02-01
Estimated Completion Date: 2026-02-01
Participants
Target number of participants: 42
Treatments
Experimental: VACAG(Venetoclax Combined with Azacitidine and CAG)regimen
Participants will receive induction as azacitidine on days 1-7, venetoclax aily on days 1-28, cytarabine q12h on days 1-7, aclacinomycin on days 1,3,5,7, and granulocyte colony-stimulating factor on days 0-8. Participants will receive second induction if not reach complete remission.
Related Therapeutic Areas
Sponsors
Leads: Hematology department of the 920th hospital

This content was sourced from clinicaltrials.gov