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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Peking University People's Hospital
• Collaborator: Ministry of Science and Technology of the People´s Republic of China
• Treatments: Arsenic Trioxide; Tretinoin

Criteria

Inclusion Criteria:

1. Newly diagnosed APL patient (with WHO performance status)

2. Age 18-70

3. ALT and AST of maximum 2·5 times the ULN, and bilirubin concentration of maximum two times the ULN

4. Creatinine concentration of maximum three times the ULN

5. Performance status of 0-2 grade (ECOG)

6. WBC ≤ 10 x 109/L before the treatment

7. Informed Consent Paper signed

Exclusion Criteria:

1. Cerebral hemorrhage

2. Pregnancy

3. Concomitant severe psychiatric condition or anything else against the fulfillment of the plan

4. Clinically significant arrhythmias or electrocardiogram abnormalities (QT>500ms)

5. Refusal to sign off the Informed Consent Paper