The goal of this clinical trial is to test the safety and efficacy of venetoclax plus CAG regimen in refractory/relapsed acute myeloid leukemia patients.
The main questions it aims to answer are: * Safety of Ven combined with CAG regimen in the treatment of relapsed/refractory AML patients * Efficacy of Ven combined with CAG regimen in the treatment of relapsed/refractory AML patients Participants will receive therapy of venetoclax and CAG regimen (Ara-C, Acla and C C-GSF)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
100 mg on the first day, and then gradually increase to the target dose of 400 mg (100 mg d1, 200 mg d2, 400 mg d3) within 3 days; After that, the drug continued to be administered until the 14th day, 400 mg/day. When combined with CYP3A or P-gp inhibitors (mainly voriconazole in this study), adjust the venetoclax dose to 100 mg/day. Ara-C 10mg/m2, ih, q12h × 14d; Acla 20mg/d × 4d; G-CSF 5ug/kg × 14d (WBC \> 30 × 10\^9/L pause)
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGCR/CRi rate
the rate of complete remission or complete remission with incomplete hematologic recovery
Time frame: 2 to 3 weeks after the end of cycle 1 (each cycle is 14 days)
CR/CRi rate
the rate of complete remission or complete remission with incomplete hematologic recovery
Time frame: 2 to 3 weeks after the end of cycle 2 (each cycle is 14 days)
MRD status
MRD-positive status was defined as FCM positivity in two consecutive BM samples at a 2-week interval, PCR positivity in two consecutive BM samples at a 2-week interval, or both FCM and PCR positivity in a single BM sample after the first-month post-HSCT. Positive FCM was defined as \>0.01% of cells with a LAIPs phenotype in \>1 BM samples after transplantation. The expressions of leukemia-associated genes were evaluated by TaqMan-based RT-PCR, including Wilms' tumor gene 1 (WT1) and genes which were determined in the diagnostic specimens.
Time frame: 2 to 3 weeks after the end of cycle 1 (each cycle is 14 days)
MRD status
MRD-positive status was defined as FCM positivity in two consecutive BM samples at a 2-week interval, PCR positivity in two consecutive BM samples at a 2-week interval, or both FCM and PCR positivity in a single BM sample after the first-month post-HSCT. Positive FCM was defined as \>0.01% of cells with a LAIPs phenotype in \>1 BM samples after transplantation. The expressions of leukemia-associated genes were evaluated by TaqMan-based RT-PCR, including Wilms' tumor gene 1 (WT1) and genes which were determined in the diagnostic specimens.
Time frame: 2 to 3 weeks after the end of cycle 2 (each cycle is 14 days)
objective remission rate(ORR)
The percentage of people in a study or treatment group who have a partial response or complete response to the treatment within a certain period of time.
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Time frame: 2 to 3 weeks after the end of cycle 1 (each cycle is 14 days)
objective remission rate(ORR)
The percentage of people in a study or treatment group who have a partial response or complete response to the treatment within a certain period of time.
Time frame: 2 to 3 weeks after the end of cycle 2 (each cycle is 14 days)
Progression-free survival (PFS)
From date of Ven plus CAG therapy beginning until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Time frame: Throughout the whole research process, assessed up to 24 months
Overall survival
From date of Ven plus CAG therapy beginning until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Time frame: Throughout the whole research process, assessed up to 24 months
The incidence of adverse events
According to Common Terminology Criteria for Adverse Events, CTCAE, V5.0, assessed up to 24 months
Time frame: Throughout the whole research process, assessed up to 24 months