Acute Promyelocytic Leukaemia Clinical Trial
Official title:
Implement Randomized, Controlled, International Multi-center Clinical Trial of Compound Realgar-Indigo Naturalis Formula Plus Retinoic Acid for Non-high-risk Acute Promyelocytic Leukaemia
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.
Acute Promyelocytic Leukaemia (APL) has been known as a type of cancer, seriously endangering
human health especially for young adults. It 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. The research and development
of oral arsenic has therefore become a hotpoint. Professor Huang, Shilin from he 210th
Hospital of PLA, according to the Prescription Theory "Jun Chen Zuo Shi", developed and
designed an oral arsenic, the Compound Realgar-Indigo Naturalis Formula. Phase I, II Clinical
trials have verified the security and efficacy of the Compound Realgar-Indigo Naturalis
Formula. Research Team led by Professor Huang, Saijun, Shanghai Institute of Haematology
(China), studied Compound Realgar-Indigo Naturalis Formula's mechanism of action from vitro
cell lines and mice.
In the following Phase II clinical trial, APL patients received Compound Realgar-Indigo
Naturalis Formula solo treatment regime. It resulted in 96.7% of CR and high safety rate
Compound Realgar-Indigo Naturalis Formula was approved by the China Food and Drug
Administration in 2009. Investigators have done a multi-centre, randomized, controlled,
non-inferiority phase 3 clinical trial in China. 242 newly diagnosed APL patients (with newly
diagnosed WBC<50×10^9/L) were enrolled. And the result showed that oral arsenic plus retinoic
acid has an anti-leukaemic efficacy similar to the intravenous arsenic treatment.
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