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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Current Primary Outcome: Disease-free survival (DFS) [ Time Frame: At 2 years ]

Original Primary Outcome: DFS [ Time Frame: At 2 years ]

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: First Affiliated Hospital Xi'an Jiaotong University

Dates:
Date Received: September 4, 2016
Date Started: September 2016
Date Completion: September 2020
Last Updated: September 13, 2016
Last Verified: August 2016