Chinese PLA General Hospital
Beijing, None Selected, 100853, China
Location status: Recruiting
NCT Number: NCT07514936
This study is a multicenter, prospective, randomized, controlled clinical trial, observing the efficacy and safety of the CACAG+Venetoclax regimen (Chidamide + Azacitidine + Aclarubicin + Cytarabine + Recombinant Human Granulocyte Colony-Stimulating Factor + Venetoclax) in elderly patients with newly diagnosed Acute Myeloid Leukemia (AML). The control group applies the standard "3+7" regimen. The aim is to improve the remission rate of AML patients, reduce the probability of adverse events, and thereby improve patient prognosis and extend patient survival.
Interested in participating?
Request Info60 year–75 year
All sexes
Interventional
Phase 2
Beijing, None Selected, 100853, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IA Regimen:
Idarubicin: 8-12 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7.
Or DA Regimen:
Daunorubicin: 60 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7.
Or MA Regimen:
Mitoxantrone: 6-10 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7.
IA Regimen:
Idarubicin: 8-12 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7.
Or DA Regimen:
Daunorubicin: 60 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7.
Or MA Regimen:
Mitoxantrone: 6-10 mg/m^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m^2 every 12 hours on days 1 to 7.
Time frame: 1 months after study treatment
a combination of complete remission (CR) and complete remission with incomplete blood count recovery (CRi)
Time frame: 1 months after the start of study 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 1 courses of chemotherapy (each course is 28 days)
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 10^9/L (1000/µL); platelet count >100 x 109/L (100,000/µL); independence of red cell transfusions.
Time frame: after each courses of chemotherapy (each course is 28 days)
Percentage of participants who achieved MRD-negative response, defined as < 1 leukemia cell per 10,000 leukocytes as assessed by flow cytometry after each courses of chemotherapy (each course is 28 days)
Time frame: 180 days after study treatment
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 treatment
Defined as the time from joining the clinical study to death due to any cause.
Time frame: From the first dose of study treatment to 30 days after the discontinuation of treatment
Defined as adverse events that occurred from the first dose of study treatment to 30 days after the discontinuation of treatment.
Time frame: 180 days after study treatment Outcome Measure
Defined as the time interval from disease remission to the occurrence of relapse or death,whichever came first.
Time frame: Within 30 days of the start of the first course of treatment
Defined as death within 30 days of chemotherapy.
Time frame: after 1 courses of chemotherapy (each course is 28 days
Disappearance of leukemia blasts in the bone marrow (<5% blasts) but without full recovery of blood counts (neutrophils <1.0 x 10⁹/L and/or platelets <100 x 10⁹/L).
Contact information is provided by the study sponsor or research team.
Dahong Liu Liu, doctor
CONTACT
Liping Dou, Doctor
CONTACT
Chinese PLA General Hospital
Other
Venetoclax-Azacitidine in Combination With Chidamide and CAG Versus Daunorubicin and Cytarabine in Fit Older Patients With Acute Myeloid Leukaemia:A Multicenter, Randomized, Controlled, Phase 3 Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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