Clinical trial NCT05659992: Clinical Study of Venetoclax Combined with CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia
Official title: Single Arm,open Label,phase I Clinical Study of Venetoclax Combined with CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: Venetoclax
CACAG
AML
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 30
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of venetoclax combined with CACAG regimen in the treatment of newly diagnosed acute myeloid leukemia.

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. In order to improve the outcome of patients with de novo AML, participants developed a venetoclax combined with CACAG regimen in the treatment of de novo AML. In this study, participants intent to evaluate the efficacy and safety of venetoclax combined with CACAG regimen in the treatment of newly diagnosed AML.

Eligibility criteria: Inclusion Criteria:

* Patients who are able to understand and willing to sign the informed consent form (ICF).
* All patients should aged 14 to75 years,no gender limitation.
* Patients who are newly diagnosed with AML.
* 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.

Exclusion Criteria:

* Patients with allergy or contraindication to the study drug;
* Female patients who are pregnant or breast-feeding.
* Patients with active infection
* 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;
* Less than 6 weeks after surgical operation of important organs.
* 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;
* The patient is not suitable for this clinical trial (poor compliance, substance abuse, etc.)

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 1 month after study treatment
Secondary outcomes:
measure: Rate of Minimal Residual Disease (MRD)-Negative Response:
timeFrame: after two courses of chemotherapy (each course is 28 days)
measure: Progression Free Survival (PFS)
timeFrame: 180 days after study treatment
measure: Overall Survival (OS)
timeFrame: 180 days after study treatment
measure: Rate of Participants With Adverse Events
timeFrame: Through 28 days post last study medication administration
measure: Partial Remission (PR) Rate:
timeFrame: 1 month after study treatment
measure: Complete Remission (CR) Rate
timeFrame: 1 month after study treatment
measure: CR with Incomplete Blood Count Recovery Rate
timeFrame: 1 month after study treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Daihong Liu Liu, doctor
role: STUDY_CHAIR
References: