Centre for Advanced Research on Innovation in Diagnosis, Prognostication, and Monitoring of Acute Myeloid Leukemia: VENCON STUDY: A Phase II-III study of Venetoclax- Based Consolidation in AML Patients in CR After Azacitidine + Venetoclax Induction
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 256
- 试验地点
- 2
研究概览
简要总结
This study evaluates optimal consolidation therapy in patients with acute myeloid leukemia who achieve complete remission after induction treatment with azacitidine and venetoclax. Although azacitidine and venetoclax is an effective lower intensity induction regimen, the most appropriate consolidation strategy after remission is not well established, particularly in resource limited settings where stem cell transplantation may not be feasible for many patients.
The study is designed as a combined phase II and phase III clinical trial conducted at Tata Memorial Centre. The objective is to assess the safety and efficacy of venetoclax based consolidation strategies in patients who have achieved remission following azacitidine and venetoclax induction therapy.
In the phase III component, patients aged 15 to 60 years who are considered fit for intensive chemotherapy will be randomized to receive high dose cytarabine consolidation with venetoclax or high dose cytarabine alone. The aim is to determine whether the addition of venetoclax to cytarabine consolidation improves treatment outcomes including relapse free survival and overall survival.
In the phase II component, patients aged 15 to 70 years who are not considered fit for intensive chemotherapy will receive venetoclax based consolidation therapy after achieving remission with azacitidine and venetoclax induction. This phase will evaluate the feasibility safety and clinical outcomes of this consolidation approach in patients who are not eligible for intensive chemotherapy.
The overall study aims to generate evidence on effective post remission treatment strategies following azacitidine and venetoclax induction in acute myeloid leukemia and to improve long term disease control in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Denovo AML in morphological remission after azacitidine venetoclax based induction therapy Age 15 to 60 years ECOG performance status 0 to 1 A patient who can give informed consent for the study The patient does not have any contraindications to receive chemotherapy Adequate hematological hepatic and renal function parameters a Hematological Hb more than 80 g per L ANC more than or equal to 1.5 x 10 9 per L platelets more than or equal to 100 x 10 9 per L b Liver functions bilirubin less than or equal to 2 times upper limit normal ULN AST ALT less than or equal to 5 times ULN alkaline phosphatase less than or equal to 6 times ULN serum albumin more than or equal to 30 g per L c Renal function creatinine less than or equal to 1.5 ULN creatinine clearance more than or equal to 60 mL per min Written patient consent form.
排除标准
- •Very high risk AML TP53 mutated AML Complex karyotype Monosomal karyotype AML with FLT3 mutation VAF greater than 5 percent Complete remission with incomplete hematologic recovery CRi More than 6 weeks since the last azacitidine venetoclax Active infection requiring IV antibiotics or antifungals Clinically significant active coronary heart disease cardiomyopathy or congestive heart failure NYHA III IV clinically significant valvular defect ECOG PS 2 or more.
研究者
Dr Lingaraj Nayak
Tata Memorial Centre