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

Acute Promyelocytic Leukemia Clinical Trial

— APL16  

Official title:

Treatment of Non-high-risk Acute Promyelocytic Leukemia With Realgar-Indigo Naturalis Formula (RIF) and All-trans Retinoid Acid (ATRA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02899169
• Other study ID #: XJTU1AF2016LSL-017
• Status: Recruiting
• Phase: Phase 3
• Start date: September 1, 2016
• Est. completion date: November 1, 2022

Study information

• Verified date: August 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Huaiyu Wang, Dr.
• Phone: 15809207527
• Email: whymed[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: November 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Promyelocytic Leukemia
• Leukemia
• Leukemia, Promyelocytic, Acute

Intervention

Drug:
• Realgar-Indigo naturalis formula

• all-trans retinoic acid

• Arsenic trioxide

• Hydroxyurea

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Tang-Du Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Lo-Coco F, Avvisati G, Vignetti M, Thiede C, Orlando SM, Iacobelli S, Ferrara F, Fazi P, Cicconi L, Di Bona E, Specchia G, Sica S, Divona M, Levis A, Fiedler W, Cerqui E, Breccia M, Fioritoni G, Salih HR, Cazzola M, Melillo L, Carella AM, Brandts CH, Morr — View Citation

Platzbecker U, Avvisati G, Cicconi L, Thiede C, Paoloni F, Vignetti M, Ferrara F, Divona M, Albano F, Efficace F, Fazi P, Sborgia M, Di Bona E, Breccia M, Borlenghi E, Cairoli R, Rambaldi A, Melillo L, La Nasa G, Fiedler W, Brossart P, Hertenstein B, Sali — View Citation

Zhu HH, Huang XJ. Oral arsenic and retinoic acid for non-high-risk acute promyelocytic leukemia. N Engl J Med. 2014 Dec 4;371(23):2239-41. doi: 10.1056/NEJMc1412035. — View Citation

Zhu HH, Wu DP, Jin J, Li JY, Ma J, Wang JX, Jiang H, Chen SJ, Huang XJ. Oral tetra-arsenic tetra-sulfide formula versus intravenous arsenic trioxide as first-line treatment of acute promyelocytic leukemia: a multicenter randomized controlled trial. J Clin — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival (DFS)		At 2 years
Secondary	Rate of overall survival (OS)		At 2 years
Secondary	Event-free survival		From date of randomization until the date of first documented event, assessed up to 36 months
Secondary	Rate of cumulative incidence of relapse (CIR)		assessed up to 3 years after randomization
Secondary	Incidence of hematological and non-hematological toxicity		From date of randomization until 2 years
Secondary	medical expense		From date of randomization until 2 years
Secondary	Total hospitalization days during therapy		At 2 years from study entry