Treatment of Non-high-risk Acute Promyelocytic Leukemia (APL) With Realgar-Indigo Naturalis Formula (RIF) (APL16)

Xi'an Jiaotong University

Status and phase: Unknown; Phase 3

Conditions: Acute Promyelocytic Leukemia

Treatments: Drug: Hydroxyurea; Drug: all-trans retinoic acid; Drug: Arsenic trioxide; Drug: Realgar-Indigo naturalis formula

Study type: Interventional

Funder types: Other

Identifiers

NCT02899169

XJTU1AF2016LSL-017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 14 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Oral Realgar-Indigo naturalis formula(RIF) Group

Experimental group

Description:

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.

Treatment:

Drug: Realgar-Indigo naturalis formula

Drug: all-trans retinoic acid

Drug: Hydroxyurea

Intravenous Arsenic Trioxide(ATO) Group

Active Comparator group

Description:

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.

Treatment:

Drug: Arsenic trioxide

Drug: all-trans retinoic acid

Drug: Hydroxyurea