A multicenter, prospective, single-arm clinical study of veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG) in the treatment of elderly untreated acute myeloid leukemia (AML)
A multicenter, prospective, single-arm clinical study of veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG) in the treatment of elderly untreated acute myeloid leukemia (AML)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Specified dose on specified days
Bing Xu
Xiamen, Fujian, China
RECRUITINGEvent-free survival (EFS)
Defined as the time interval from treatment initiation to the occurrence of induction failure, relapse, or death, whichever came first.
Time frame: Up to 60 months
Complete Remission (CR) rate
The percent of participants with complete remission (CR) was defined in accordance with the IWG Response Criteria in AML.
Time frame: Up to 60 months
Overall Survival (OS)
OS will be measured from the date of registration to the date of the event (i.e., death) or the date of last follow-up to evaluate that event. Patients who are event-free at their last follow-up evaluation will be censored at that time point.
Time frame: Up to 60 months
Overall Response Rate (ORR)
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: Up to 60 months
General Health Status/Quality of Life
Will be assessed by Questionnaire.
Time frame: Up to 60 months
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