Randomized,International Multi-center Clinical Trial of RIF Plus RA for Non-high-risk APL
Status:
Not yet recruiting
Trial end date:
2023-08-31
Target enrollment:
Participant gender:
Summary
Acute Promyelocytic Leukaemia (APL) has been known as a type of cancer, which is of great
significance to improve its eradication rate. Recent clinical trials show that ATRA plus ATO
treatment regimen can result in complete response (CR) in 90-94% of patients and 5-year
disease-free survival (DFS) in more than 90% of patients. However, the ATRA plus ATO
treatment regimen can achieve considerate survival rate, patients still need to receive
infusion therapy in hospital. If oral arsenic can replace intravenous ATO without reduction
of the efficacy, patients would not need to be administered to receive treatment, which would
highly increase their quality of lives. Phase I, II Clinical trials have verified the
security and efficacy of the Compound Realgar-Indigo Naturalis Formula. Compound
Realgar-Indigo Naturalis Formula was approved by the China Food and Drug Administration in
2009. Investergators have done a multi-centre, randomized, controlled, non-inferiority phase
3 clinical trial in China. And the result showed that oral arsenic plus retinoic acid has an
anti-leukaemic efficacy similar to the intravenous arsenic treatment. So Investigators
performed an international multi-center, Randomized controlled clinical trialsto compare the
efficacy of oral RIF plus ATRA with intravenous arsenic trioxide plus ATRA in patients with
non-high-risk APL in different racial types.
Phase:
Phase 3
Details
Lead Sponsor:
Peking University People's Hospital
Collaborator:
Ministry of Science and Technology of the People´s Republic of China