This is a multicenter, prospective, randomized controlled clinical study comparing the efficacy and safety of CLAG+VEN and CLAG regimens in relapsed/refractory(r/r) AML.
The efficacy and prognosis of relapsed/refractory(r/r) AML are very poor, and there is no standard chemotherapy regimen were defined for r/r AML. Cladribine, a purine analogue, exerts cytotoxic, proapoptotic, and antiproliferative effects on AML cells. Previous studies have confirmed the efficacy of cladribine in the treatment of r/r AML, with a response rate of 30-45%.Our previous experience has shown that CLAG in combination of venetoclax are effective with tolerable toxicity profiling. However, there is a lack of multicenter, prospective, randomized controlled trials to further confirm the results. Therefore, a clinical study is planned to evaluate the efficacy and safety of CLAG+VEN compared to CLAG in r/r AML who were eligible for intensive therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
172
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Composite Complete remission (cCR, CR+CRi)
Will compare composite complete remission(CR+CRi: complete response \[CR\] and complete response with incomplete blood count recovery \[CRi\]) between CLAGV regimen and CLAG regimen
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Overall Response rate (ORR)
Will compare ORR(completed remission\[CR\], completed remission with incomplete blood count recovery\[CRi\], and partial remission\[PR\]) rates between the study arms
Time frame: At the end of Cycle 1 (each cycle is 28 days)
MRDneg CR rate
Will compare MRD-negative cCR rates between the study arms
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Overall Survival(OS)
Will compare OS between the study arms
Time frame: 1 year post treatment
Relapse free survival(RFS)
Will compare RFS between the study arms
Time frame: 1 year post treatment
Duration of completed response(DoR)
Will compare DoR between the study arms
Time frame: 1 year post treatment
Relapse rate
Will compare relapse rate between the study arms
Time frame: 1 year post treatment
Incidence of Adverse Events
Will use the CTCAE (National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events) version 5.0 for toxicity and adverse event reporting. Will describe the incidence of infection and treatment-related adverse events.
Guopan Yu
CONTACT
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Given PO
Time frame: Duration of treatment, up to 1 year