This study aims to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine and CAG as induction regimen in Patients with Refreactory/Relapse Acute Myeloid Leukemia.
This is an open-label, multicenter, phase II clinical trial to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine (VA) and CAG (G-CSF priming, low dose cytarabine, and aclarubicin) as induction regimen in Patients with Refreactory/Relapse Acute Myeloid Leukemia(AML). Previous studies have shown that venetoclax plus intense chemotherapy represent promising efficacy in de novo AML patients with high complete remission rates and good tolerance. Our preliminary results suggest that venetoclax in combination with azacitidine and CAG are well tolerated and effective for patients who were diagnosed with refreactory/relapse AML. Thus, this phase II clinical trial is going to further explore its efficacy and safety. It is expected that about 42 patients will take part in this trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
VA regimen Drug: Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-21); Drug: Azacitidine 75 mg/m2 subcutaneously once daily on days 1-7. CAG regimen Drug: Cytarabine 10mg/m2 subcutaneously q12h on days 1-7 Drug: Aclacinomycin 12-14mg/m2 on days 1,3,5,7 Drug: Granulocyte colony-stimulating factor 5ug/kg on days 0-8, discontinue if WBC \>20×109/L
Department of Hematology,920th Hospital of Joint Logistic Support Force of People's Liberation
Kunming, Yunnan, China
RECRUITINGOverall response rate (ORR)
The overall remission rate (ORR) was defined as the percentage of patients who achieved complete remission (CR), complete remission with incomplete count recovery (CRi), or morphologic leukemia free state (MLFS) per the International Working Group criteria for AML.
Time frame: up to 2 cycles from the start of VACAG regimen (each cycle is 28 days)
Rate of Minimal Residual Disease (MRD) negativity
Percentage of participants who converted to MRD \< 10\^-3 by flow cytometry before initiation of consolidation therapy.
Time frame: up to 2 years
Incidence of Treatment-Emergent Adverse Events
Safety and tolerability analysis will be assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: up to 2 years
Duration of myelosuppression
The duration of absolute value of peripheral blood neutrophils \<0.5×10\^9/L and platelet count \<50×10\^9/L during myelosuppression.
Time frame: up to 2 years
Leukaemia-free survival
Leukaemia-free survival will be defined as the time since date of CR until either relapse or death in remission.
Time frame: up to 2 years
Overall survival
Overall Survival be defined as the time from administration of the initial doses until death from any cause.
Time frame: up to 2 years
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