Treatment of Non-high-risk Acute Promyelocytic Leukemia With Realgar-Indigo Naturalis Formula (RIF) and All-trans Retinoid Acid (ATRA)
试验速览
- 阶段
- 3 期
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
The investigators design a multicenter randomized controlled trial to prove that RIF plus ATRA is possibly superior to ATO plus ATRA as consolidation and maintenance treatment for the patients with non-high-risk APL.
详细描述
Acute promyelocytic leukemia (APL) is a unique subtype of acute myeloid leukemia (AML) which accounts for 10-15% of acute myeloid leukemia. It is characterized by the PML-RARA fusion gene generated by the t(15;17)(q22;q21) chromosomal translocation. The application of ATRA and ATO, make APL from highly fatal to highly curable. APL0406 study proves that ATRA plus arsenic trioxide is at least not inferior and may be superior to ATRA plus chemotherapy in the treatment of patients with non-high-risk APL. Now, the arsenic trioxide has already became the based regimen as targeted first-line treatment without chemotherapy. A study shows that oral RIF plus ATRA is not inferior to intravenous ATO plus ATRA as maintenance treatment of APL. The investigators design a multicenter randomized controlled trial to prove that RIF plus ATRA is possibly superior to ATO plus ATRA as consolidation and maintenance treatment for the patients with non-high-risk APL. Application of oral RIF decrease the total hospitalization days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 14 to 70 years
- •Newly diagnosed APL with t(15;17)(q22;q12)
- •Before treatment the Peripheral blood white blood cell count≤10×109/L
- •Patients who can complete the entire treatment process
- •Patients or their families signed written informed consent
排除标准
- •Be allergic to the drug ingredient, the supplementary material or the allergic constitution person
- •Cardiac insufficiency, renal insufficiency, significant arrhythmias, EKG abnormalities or other important organ dysfunction
- •Combined with other malignant tumors
- •Pregnant and lactating women
- •Participants in other drug trials in the last 3 months
- •Suffering from mental illness or other circumstances which unable to carry out the plan
- •Other patients who were not suitable for the study
研究组 & 干预措施
Oral Realgar-Indigo naturalis formula(RIF) Group
Induction therapy: ATO and ATRA, which will maintain until complete hematologic remission. Hydroxyurea should be administrated until WBC count decrease <10x109/L. Consolidation therapy: RIF（60mg/kg/d) and ATRA 4 weeks on and 2 weeks off, until the fusion gene expression is negative. Maintenance therapy: RIF and ATRA 2 weeks on and 2 weeks off for a total of 6 courses.
干预措施: Realgar-Indigo naturalis formula (Drug)
Oral Realgar-Indigo naturalis formula(RIF) Group
Induction therapy: ATO and ATRA, which will maintain until complete hematologic remission. Hydroxyurea should be administrated until WBC count decrease <10x109/L. Consolidation therapy: RIF（60mg/kg/d) and ATRA 4 weeks on and 2 weeks off, until the fusion gene expression is negative. Maintenance therapy: RIF and ATRA 2 weeks on and 2 weeks off for a total of 6 courses.
干预措施: all-trans retinoic acid (Drug)
Oral Realgar-Indigo naturalis formula(RIF) Group
Induction therapy: ATO and ATRA, which will maintain until complete hematologic remission. Hydroxyurea should be administrated until WBC count decrease <10x109/L. Consolidation therapy: RIF（60mg/kg/d) and ATRA 4 weeks on and 2 weeks off, until the fusion gene expression is negative. Maintenance therapy: RIF and ATRA 2 weeks on and 2 weeks off for a total of 6 courses.
干预措施: Hydroxyurea (Drug)
Intravenous Arsenic Trioxide(ATO) Group
Induction therapy: ATO and ATRA, which will maintain until complete hematologic remission. Hydroxyurea should be administrated until WBC count decrease <10x109/L. Consolidation therapy: ATO and ATRA 4 weeks on and 2 weeks off, until the fusion gene expression is negative. Maintenance therapy: ATO and ATRA 2 weeks on and 2 weeks off for a total of 6 courses.
干预措施: all-trans retinoic acid (Drug)
Intravenous Arsenic Trioxide(ATO) Group
Induction therapy: ATO and ATRA, which will maintain until complete hematologic remission. Hydroxyurea should be administrated until WBC count decrease <10x109/L. Consolidation therapy: ATO and ATRA 4 weeks on and 2 weeks off, until the fusion gene expression is negative. Maintenance therapy: ATO and ATRA 2 weeks on and 2 weeks off for a total of 6 courses.
干预措施: Arsenic trioxide (Drug)
Intravenous Arsenic Trioxide(ATO) Group
Induction therapy: ATO and ATRA, which will maintain until complete hematologic remission. Hydroxyurea should be administrated until WBC count decrease <10x109/L. Consolidation therapy: ATO and ATRA 4 weeks on and 2 weeks off, until the fusion gene expression is negative. Maintenance therapy: ATO and ATRA 2 weeks on and 2 weeks off for a total of 6 courses.
干预措施: Hydroxyurea (Drug)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: At 2 years
次要结局
- Rate of overall survival (OS)(At 2 years)
- Event-free survival(From date of randomization until the date of first documented event, assessed up to 36 months)
- Rate of cumulative incidence of relapse (CIR)(assessed up to 3 years after randomization)
- Incidence of hematological and non-hematological toxicity(From date of randomization until 2 years)
- medical expense(From date of randomization until 2 years)
- Total hospitalization days during therapy(At 2 years from study entry)