Treatment of Non-high-risk Acute Promyelocytic Leukemia (APL) With Realgar-Indigo Naturalis Formula (RIF)
- Conditions
- Acute Promyelocytic Leukemia
- Interventions
- Registration Number
- NCT02899169
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 110
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intravenous Arsenic Trioxide(ATO) Group Hydroxyurea 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. Oral Realgar-Indigo naturalis formula(RIF) Group Realgar-Indigo naturalis formula 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. Oral Realgar-Indigo naturalis formula(RIF) Group all-trans retinoic acid 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. Oral Realgar-Indigo naturalis formula(RIF) Group Hydroxyurea 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. Intravenous Arsenic Trioxide(ATO) Group all-trans retinoic acid 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. Intravenous Arsenic Trioxide(ATO) Group Arsenic trioxide 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.
- Primary Outcome Measures
Name Time Method Disease-free survival (DFS) At 2 years
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China