Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020, China
Location status: Recruiting
NCT Number: NCT06635681
Acute myeloid leukemia (AML) is a common hematological malignancy. Intensive chemotherapy is the main treatment in fit patients.
Retrospective studies have shown that Venetoclax is highly effective in elder AML patients with IDH2 and NPM1 mutations while in those with TP53 and FLT3 mutations, the combination of azacitidine with Venetoclax showed an increased remission rate without improved survival.
Since AML is a highly heterogeneous disease, it is not clear which genetic type of adult AML patients would benefit from Venetoclax combined with intensive chemotherapy.
Therefore, this study intends to conduct a phase II clinical trial to investigate the efficacy of intensive chemotherapy combined with Venetoclax in adult AML patients, and reveal the efficacy of Venetoclax added to chemotherapy regimens for AML with different cytogenetic and molecular subgroups.
Interested in participating?
Request Info14 year–60 year
All sexes
Interventional
Phase 2
Tianjin, Tianjin Municipality, 300020, China
Location status: Recruiting
Patients will receive 1 course of intensive chemotherapy combined with venetoclax for induction and those who achieved complete remission will receive 3 courses of intermediate-dose cytarabine combined with Venetoclax for consolidation. After consolidation therapy, Venetoclax in combination with azacitidine will be applied for 6 courses as maintenance treatment. Allogeneic hematopoietic stem cell transplantation is recommended for high-risk groups and intermediate-risk with positive measurable residual disease.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects who meet any of the following criteria are excluded from the study:
60mg/m2/d d1-3 in Induction therapy
Cytarabine 100mg/m2/d d1-7 in Induction therapy, 2g/m2 q12h d1-3 in Consolidation therapy
100mg d-2, 200mg d-1, 400mg d1-7 in Induction therapy, 400mg d1-7 in Consolidation therapy and Maintenance treatment
75mg/m2/d d1-5
Time frame: up to 2 years after the date of the last enrolled participants
All patients definitions for the trial; From the date of enrollment to the time of treatment failure after two courses of induction therapy, recurrence after CRc, date of all-cause death, or the date of last survival follow-up.
Time frame: up to 1 years after the date of the last enrolled participants
The ratio of CR/CRh/CRi with negative MRD detected by flow cytometry after induction, consolidation, and maintenance therapy.
Time frame: up to 1 years after the date of the last enrolled participants
The ratio of CR/CRh/CRi with negative MRD detected by PCR after induction, consolidation, and maintenance therapy.
Time frame: up to 2 years after the date of the last enrolled participants
Used to evaluate all patients who enter clinical trials. From the date of entry into the trial until the date of patient death (including any cause) or last survival follow-up.
Time frame: within 30 days of the date of the last enrolled participants
Percentage of patients who died within 30 days from enrollment.
Time frame: within 60 days of the date of the last enrolled participants
Percentage of patients who died within 60 days from enrollment.
Time frame: up to 3 months after the date of the last enrolled participants
The ratio of patients achieved CR/CRh/CRi after two courses of induction therapy.
Time frame: up to 2 years after the date of the last enrolled participants
Defined only for patients achieving CRc; measured from the date of achievement of remission until the date of hematologic relapse or death from any cause; patients not known to have relapsed or died at last follow-up are censored on the date they were last known to be alive
Contact information is provided by the study sponsor or research team.
Institute of Hematology & Blood Diseases Hospital, China
Other
Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of Acute Myeloid Leukemia : a Multi-center, Single-arm Clinical Trial
Acronym: DAV-AML-2024
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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