Clinical trial NCT06928376: A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients
Official title: A Multicenter, Prospective, Randomized Controlled Study of the Standard "3+7" Regimen Versus Venetoclax Combined With CACAG Regimen in Newly Diagnosed Adult Patients With Intermediate- and High-risk Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
First Line Therapy
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Harbin Medical University
name: Yantai Yuhuangding Hospital
name: Chinese People's Liberation Army Air Force General Hospital
name: The General Hospital of Western Theater Command
name: 940 Hospital of the People's Liberation Army Joint Logistic Support Force
name: The 960th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army
name: the First People's Hospital of Jining
First posted: 2025-04-15
Enrollment: 160
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: Despite the availability of hematopoietic stem cell transplantation and the emergence of many new therapeutic drugs, the prognosis of newly diagnosed acute myeloid leukemia is still poor.Over the past years, combination chemotherapy with anthracycline and standard dose cytarabine (standard "3+7" induction therapy) remains the standard induction. In order to improve the outcome of patients with de novo AML, we developed a venetoclax combined with CACAG regimen in the treatment of de novo AML. In this study, we intent to compare the efficacy and safety of venetoclax combined with CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed intermediate- or high-risk acute myeloid leukemia.

Eligibility criteria: Inclusion Criteria:

Age 14 to 75 years (no gender limitation) Newly diagnosed with intermediate- or high-risk AML (excluding M3) Liver function: ALT and AST ≤ 2.5 times upper limit of normal; bilirubin ≤ 2 times upper limit of normal Renal function: creatinine ≤ upper limit of normal No uncontrolled infections, organ dysfunction, or severe mental illness ECOG performance status score of 0-2 and predicted survival ≥ 4 months No severe allergic constitution

Exclusion Criteria:

Allergy or contraindication to the study drug Pregnant or breastfeeding female patients Known history of alcohol or drug addiction (due to potential non-compliance) Mental illness or conditions preventing protocol compliance Less than 6 weeks after major organ surgery Liver function: ALT and AST \> 2.5 times upper limit of normal; bilirubin \> 2 times upper limit of normal Renal function: creatinine \> upper limit of normal Deemed unsuitable for the clinical trial (poor compliance, substance abuse, etc.)

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Primary outcomes:
measure: Composite Complete Remission (CRc) Rate after 1 course of treatment
timeFrame: 1 months after study treatment
Secondary outcomes:
measure: Overall Response Rate (ORR) after 1 course of treatment
timeFrame: 1 months after the start of study treatment
measure: Complete Remission (CR) Rate after 1 courses of treatment
timeFrame: after 1 courses of chemotherapy (each course is 28 days)
measure: Rate of Minimal Residual Disease (MRD)-Negative Response
timeFrame: after each courses of chemotherapy (each course is 28 days)
measure: Event-free survival
timeFrame: 180 days after study treatment
measure: Overall Survival
timeFrame: 180 days after study treatment
measure: Treatment-related adverse events
timeFrame: From the first dose of study treatment to 30 days after the discontinuation of treatment
measure: Disease-free survival
timeFrame: 180 days after study treatment
measure: Early death
timeFrame: Within 30 days of the start of the first course of treatment
measure: Complete Remission with Incomplete Blood Count Recovery (CRi)after 1 courses of treatment
timeFrame: after 1 courses of chemotherapy (each course is 28 days)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References: