Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14-75
SponsorChinese PLA General Hospital
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
Patients with allergy or contraindication to the study drug;
Female patients who are pregnant or breast-feeding.
Patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment;
Patients with mental illness or other states unable to comply with the protocol;
Trial design
Treatments tested in this trial
- Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor
- Best-Available Therapy(BAT) Regimen
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Chinese PLA General Hospital
Lead sponsor
940 Hospital of the People's Liberation Army Joint Logistic Support Force
Collaborator
The General Hospital of Western Theater Command
Collaborator
The General Hospital of Northern Theater Command
Collaborator
960th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Collaborator
Air Force Military Medical University, China
Collaborator
Yantai Yuhuangding Hospital
Collaborator
People's Liberation Army (PLA) Strategic Support Force Characteristic Medical Center
Collaborator
First Hospital of China Medical University
Collaborator
Source ClinicalTrials.gov