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

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborator: Tang-Du Hospital
• Treatments: Arsenic Trioxide; Hydroxyurea; Tretinoin

Criteria

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