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

First Affiliated Hospital Xi'an Jiaotong University110 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

Acute Promyelocytic Leukemia

Interventions

Realgar-Indigo naturalis formulaDRUG

all-trans retinoic acidDRUG

Arsenic trioxideDRUG

HydroxyureaDRUG

Eligibility

Sex: ALLMin age: 14 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

RECRUITING

Outcomes

Primary Outcomes

Disease-free survival (DFS)

Time frame: At 2 years

Secondary Outcomes

Rate of overall survival (OS)

Time frame: At 2 years

Event-free survival

Time frame: From date of randomization until the date of first documented event, assessed up to 36 months

Rate of cumulative incidence of relapse (CIR)

Time frame: assessed up to 3 years after randomization

Incidence of hematological and non-hematological toxicity

Time frame: From date of randomization until 2 years

medical expense

Time frame: From date of randomization until 2 years

Total hospitalization days during therapy

Time frame: At 2 years from study entry

Central Contacts

Huaiyu Wang, Dr.

CONTACT

15809207527 whymed@126.com

Data from ClinicalTrials.gov

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