A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients
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 the CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed intermediate- or high-risk acute myeloid leukemia (AML).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor
DrugAzacytidine (75 mg/m2/day, days 1 to 7). Cytarabine (75-100 mg/m2 bid, days 1 to 5). Aclacinomycin(20 mg/day, days 1,3,5). Chidamide (30 mg/day , days 1,4,8,11). Venetoclax (400 mg/day, days 1 to 14,Combined with posaconazole reduced to 100 mg/day,Combined with voriconazole reduced to 200 mg/day ). Granulocyte colony-stimulating factor (300 μg/day, day 0 until agranulocytosis recovery)
"3+7"
DrugIA regimen: Idarubicin (8-10 mg/m2) for 3 days . Cytarabine (75-100mg/m2, every 12 hrs) for 7 days. DA regimen: Daunorubicin(60 mg/m2) for 3 days. Cytarabine (75-100mg/m2, every 12 hrs) for 7 days.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Venetoclax Combined With CACAG RegimenExperimental treatment 1 intervention
Group B: "3+7" RegimenActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Composite Complete Remission (CRc) Rate after 1 course of treatment
a combination of complete remission (CR) and complete remission with incomplete blood count recovery (CRi)
Time frame
1 months after study treatmentSecondary 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 treatment2
Complete Remission (CR) Rate after 1 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 1 courses of chemotherapy (each course is 28 days)3
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 each courses of chemotherapy (each course is 28 days)4
Event-free survival
Defined as the time interval from treatment initiation to the occurrence of induction failure,relapse,or death,whichever came first.
Time frame
180 days after study treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Chinese PLA General Hospital
Lead sponsor
First Affiliated Hospital of Harbin Medical University
Collaborator
Yantai Yuhuangding Hospital
Collaborator
The General Hospital of Western Theater Command
Collaborator
940 Hospital of the People's Liberation Army Joint Logistic Support Force
Collaborator
960th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Collaborator
Jining First People's Hospital
Collaborator
Source ClinicalTrials.gov