NCT07392814尚未招募1 期
Single-Center Phase 1 Study With Escalating Doses of Tocilizumab in Combination With Venetoclax and Azacitidine Chemotherapy in Patients With Acute Myeloid Leukemia (AML). TOCIVENA
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- DLT
研究概览
简要总结
This is a phase 1, open label, interventional, single center, in patients with Acute Myeloid Leukemia (AML). This study will investigate dose escalation of tocilizumab in combination with venetoclax and azacitidine chemotherapy.
The patient population will consist of adults men and women at least 18 years, who meet eligibility criteria. In this study propose combining tocilizumab with the standard treatment of azacitidine and venetoclax for patients with AML who are not eligible for intensive treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First-line AML regardless of karyotype and molecular profile
- •ECOG <= 3
- •Patient eligible for chemotherapy combining azacitidine and venetoclax
- •Informed consent
- •Liver function tests: transaminases < 3x normal, bilirubin < 1.5x normal
- •Creatinine clearance > 30 ml/min
排除标准
- •Patients eligible for intensive "3+7" treatment
- •Uncontrolled infection
- •Active and/or treated infection with Hep B, C, or HIV
- •No social security or other health insurance
- •Pregnant women or patients who cannot use contraception due to fertility
- •Breastfeeding women
- •Adults under guardianship, conservatorship, or legal protection
- •Hypersensitivity to any of the active substances or excipients (see SPCs)
- •Patients unable to understand spoken or written French
研究组 & 干预措施
Tocilizumab
Experimental
- Level 1: 4 mg/kg on Day 1 of cycles 1 to 3
- Level 2: 6 mg/kg on Day 1 of cycles 1 to 3 (starting dose for the first cohort)
- Level 3: 8 mg/kg on Day 1 of cycles 1 to 3
- Level 4: 4 mg/kg on Days 1 and 15 of cycles 1 to 3
干预措施: increase dose of tocilizumab (Drug)
结局指标
主要结局
DLT
时间窗: 42 days
number of DLT
次要结局
- Death(48 months)
- follow - up(48 months)
- relapse(48 months)
- death(48 months)
- follow up(48 months)
- neutrophil(48 months)
- platelets(48 months)
- infection(48 months)
- cytokine(48 months)
- tocilizumab(48 months)
- response to treatment(28 months)
研究者
研究点 (1)
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