Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
NCT Number: NCT05659992
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.
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Notify Me14 year–75 year
All sexes
Interventional
Phase 2
Beijing, Beijing Municipality, 100853, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 month after 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).
Time frame: after two 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 or < 0.01% as assessed by PCR of a bone marrow aspirate.
Time frame: 180 days after study treatment
PFS was defined as time from the date joining the clinical study to the date of disease progression (PD) or date of death due to any cause, whichever occurred 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: Through 28 days post last study medication administration
Percentage of Participants with 3 or 4 grade Adverse Events reported through 28 days post last study medication administration.
Time frame: 1 month after study treatment
All hematologic criteria of CR; decrease of bone marrow blast percentage to 5 to 25 percent; and decrease of pre-treatment bone marrow blast percentage by at least 50 percent.
Time frame: 1 month after study treatment
Defined in accordance with the IWG Response Criteria in AML. Bone marrow blasts &lt;5 percent; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count &gt;1.0 x 109/L (1000/µL); platelet count &gt;100 x 109/L (100,000/µL); independence of red cell transfusions.
Time frame: 1 month after study treatment
All CR criteria except for residual neutropenia (&lt;1.0 x 109/L (1000/µL)) or thrombocytopenia (&lt;100 x 109/L (100,000/µL)
Chinese PLA General Hospital
Other
Single Arm,open Label,phase I Clinical Study of Venetoclax Combined with CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia
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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