A Prospective,Randomized,and Comparative Study on the Efficacy of Venetoclax Combined With CACAG Regimen and BAT Regimen in the Treatment of Relapsed/Refractory 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 CACAG regimen with BAT regimen in the treatment of relapsed/refractory acute myeloid leukemia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 75
Healthy Volunteers: f
View:

• Patients who are able to understand and willing to sign the informed consent form (ICF).

• All patients should aged 14 to 75 years,no gender limitation.

• Patients with R/R AML, diagnosed in accordance with the 2021 edition of the CMA criteria

• Liver function: ALT and AST≤2.5 times the upper limit of normal ,bilirubin≤2 times the upper limit of normal;

• Renal function: creatinine ≤the upper limit of normal;

• Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness;

• The score of Eastern Cooperative Oncology Group (ECOG) is 0-3,and the predicted survival ≥ 4 months.

• Patients without severe allergic constitution.

Locations
Other Locations
China
Chinese PLA General Hospital
RECRUITING
Beijing
Contact Information
Primary
Daihong Liu, doctor
daihongrm@163.com
+8613681171597
Backup
Liping Dou, doctor
lipingruirui@163.com
+8613681207138
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 200
Treatments
Experimental: Venetoclax Combined With CACAG Regimen
Venetoclax combined with CACAG regimen for relapsed/refractory AML. Recipients were randomized and those entering the experimental group received azacytidine,cytarabine,aclacinomycin,chidamide,venetoclax and granulocyte colony-stimulating factor. Azacytidine was used as 75 mg/m2/day from day 1 to day 7.Cytarabine was used as 75-100 mg/m2 bid from day 1 to day 5. Aclacinomycin was used as 20 mg/day on days 1,3,5. Chidamide was used as 30 mg/day on days 1,4,8,11. Venetoclax was used as 400 mg/day from day 1 to day 14.Granulocyte colony-stimulating factor was used as 300 ug/day from day 0 until agranulocytosi recovery.
Active_comparator: Best-Available Therapy(BAT) Regimen
BAT regimen for relapsed/refractory AML.Recipients were randomized and those entering this group received FLAG/CLAG/MAE/DCAG/HAA/HAD regimen.
Sponsors
Collaborators: 940 Hospital of the People's Liberation Army Joint Logistic Support Force, Air Force Military Medical University, China, The 960th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army, People's Liberation Army (PLA) Strategic Support Force Characteristic Medical Center, The General Hospital of Northern Theater Command, Yantai Yuhuangding Hospital, First Hospital of China Medical University, The General Hospital of Western Theater Command
Leads: Chinese PLA General Hospital

This content was sourced from clinicaltrials.gov