Effectiveness and Safety of Therapy Based on Attenuated Arsenic Trioxide Plus Low Doses of All-trans Retinoic Acid as Remission Induction Therapy in Patients With Acute Promyelocytic Leukemia Phase 1/2 Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
ATRA is the standard of care for all patients with APL. The use of lower doses of ATRA has been shown since the 1990s to achieve therapeutic efficacy with doses of 25mg/m2/day. ATO demonstrated considerable effectiveness in this disease. More recently, an attenuated regimen has been proven to be effective. In this study we intent to demonstrate the effectiveness of combined therapy of low-dose ATRA plus attenuated dose ATO.
详细描述
The use of lower doses of ATRA has been shown since the 1990s to achieve therapeutic plasma concentrations sufficient to achieve therapeutic efficacy with doses of 25mg/m2/day. ATO alone demonstrated considerable effectiveness in this disease. More recently, an attenuated regimen has been proven to be effective in inducing similar remission rates and achieving prolonged survival, also demonstrating a reduction in associated toxicities, mainly hepatic and cardiac when using this new scheme.
The investigators will conduct a phase 1/2, non-randomized, single center, non-comparative clinical trial to demonstrate the effectiveness of combined therapy of low-dose ATRA plus attenuated dose ATO which is accessible to a population with limited resources while maintaining acceptable efficacy and safety.
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
盲法说明
This is an Open label study
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
- •Age >18 years
- •Both genders
- •new diagnosis of APL
- •Diagnosis of relapsed APL who have not been previously treated with ATO
- •Morphological diagnosis of APL confirmed by PCR or FISH
排除标准
- •Poor functional status (ECOG>2)
- •Organic dysfunction (Marshall score ≥2)
- •Pregnancy
- •Heart failure (NYHA III or IV)
- •Renal failure (GFR <30 ml/min/1.72m2)
- •History of ventricular arrhythmias or uncontrolled arrhythmias
- •Acute myocardial infarction, unstable angina, or stable angina in the last six months
- •Uncontrolled active infection
- •Liver disease (Child-Pugh C)
研究组 & 干预措施
Induction with attenuated ATO plus low-dose ATRA
Remission induction therapy will be administrated as ATRA 25/mg/m2/day for 28 continuous days without interruption if APL is suspected. ATO 0.3mg/kg/day for days 1-5 (5 doses) and then 0.25 mg/kg/day every other day twice a week for the next 3 weeks (6 doses).
干预措施: Arsenic trioxide (Drug)
Induction with attenuated ATO plus low-dose ATRA
Remission induction therapy will be administrated as ATRA 25/mg/m2/day for 28 continuous days without interruption if APL is suspected. ATO 0.3mg/kg/day for days 1-5 (5 doses) and then 0.25 mg/kg/day every other day twice a week for the next 3 weeks (6 doses).
干预措施: all-trans retinoic acid (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: 28 days
Safety will be defined by the number of patients deceased after 1 induction cycle of 28 days
次要结局
- Overall response(28 days)
- Progression-free survival(6 months)
- Event-free survival(6 months)
- Rate of treatment discontinuation due to toxicity.(28 days)
研究者
David Gomez Almaguer
Head of Hematology Service
Hospital Universitario Dr. Jose E. Gonzalez