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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor
Drug1. Azacytidine (75mg/m2/day, days 1 to 7). 2. Cytarabine (75-100mg/m2 q12h, days 1 to 5). 3. Aclacinomycin(20mg/day, days 1,3,5). 4. Chidamide(30mg/day , days 1,4,8,11). 5. Venetoclax (100mg on day 1,200mg on day 2,400mg on days 3-14). 6. Granulocyte colony stimulating factor (300 μg/day, day 0 until agranulocytosis recovery)
Best-Available Therapy(BAT) Regimen
Drug1. FLAG regimen:Fludarabine(30mg/m2,days 1-5)+Cytarabine (1-2g/m2 applied 4h after fludarabine, days 1 to 5)+Granulocyte colony-stimulating factor(300ug/day,days 0 to 5) 2. CLAG regimen:Cladribine(5mg/2,days 1-5)+Cytarabine (1-2g/m2 applied 4h after fludarabine, days 1 to 5)+Granulocyte colony-stimulating factor(300ug/day,days 0 to 5) 3. MAE regimen:Mitox(10mg/m2,days 1 to 5)+VP-16(100mg/m2,days 1 to 5)+Cytarabine (100-150mg/m2,days 1 to 7) 4. DCAG regimen:Decitabine(20mg/m2,days 1 to 5)+Aclacinomycin(20mg/day on days 1,3,5)+Cytarabine (100mg q12h,days 1 to 5)+Granulocyte colony-stimulating factor(300 ug/day,day 0 until agranulocytosi recovery) 5. HAA regimen:HHT(2mg/m2,days 1 to 7)+Aclacinomycin(20mg/day,days 1 to 7) and Cytarabine (100-200 mg/m2, days 1 to 5); 6. HAD regimen:HHT(2mg/m2,days 1 to 7)+Daunorubicin(45mg/m2/day,days 1 to 3)+Cytarabine (100-200 mg/m2,days 1 to 5).
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Venetoclax Combined With CACAG RegimenExperimental treatment 1 intervention
Group B: Best-Available Therapy(BAT) RegimenActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Overall Response Rate (ORR) after 1 course of treatment
Defined as the percentage of participants achieving a best overall response of complete response (CR), CR with incomplete blood count recovery (CRi), or partial response (PR).Biological characteristics exploratory studies were analyzed by single-cell sequencing and Atac-seq. Further, according to European LeukemiaNet risk group, we analyzed the outcomes of patients by molecular subtype as a sub-group analysis.
Time frame
1 months after the start of study treatmentSecondary outcomes
1
Complete Remission (CR) Rate after 1 course of treatment
Defined in accordance with the IWG Response Criteria in AML. Bone marrow blasts\<5 percent; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0 x 109/L (1000/µL); platelet count \>100 x 109/L (100,000/µL); independence of red cell transfusions.
Time frame
2 months after study treatment2
Complete Remission (CR) Rate after 2 courses of treatment
Defined in accordance with the IWG Response Criteria in AML. Bone marrow blasts\<5 percent; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0 x 109/L (1000/µL); platelet count \>100 x 109/L (100,000/µL); independence of red cell transfusions.
Time frame
After two courses of chemotherapy (each course is 28 days)3
Overall Response Rate (ORR) after 2 course of treatment
Defined as the percentage of participants achieving a best overall response of complete response (CR), CR with incomplete blood count recovery (CRi), or partial response (PR).Biological characteristics exploratory studies were analyzed by single-cell sequencing and Atac-seq. Further, according to European LeukemiaNet risk group, we analyzed the outcomes of patients by molecular subtype as a sub-group analysis.
Time frame
After two courses of chemotherapy (each course is 28 days)4
Rate of Minimal Residual Disease (MRD)-Negative Response
Percentage of participants who achieved MRD-negative response, defined as \< 1 leukemia cell per 10,000 leukocytes as assessed by flow cytometry.
Time frame
After two courses of chemotherapy (each course is 28 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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