Early Use of Realgar-Indigo Naturalis Formula (RIF) Combined With All-trans Retinoic Acid (ATRA) for Treating Acute Promyelocytic Leukemia (APL).

Study Title: Multicenter, Randomized Controlled Clinical Study on Early Application of Realgar-Indigo Naturalis Formula (RIF) for Treatment of Acute Promyelocytic Leukemia (APL) Sponsor: Xi'an Jiaotong University First Affiliated Hospital Principal Investigator: Wang Huaiyu Study Description: This multicenter, randomized controlled trial evaluates whether early induction treatment with oral Realgar-Indigo Naturalis Formula (RIF) combined with all-trans retinoic acid (ATRA) reduces early death rates in patients with acute promyelocytic leukemia (APL). APL is a subtype of acute myeloid leukemia characterized by a high risk of early death, largely due to coagulopathy and bleeding events, especially in high-risk patients with elevated white blood cell counts. Traditional treatment with ATRA and arsenic trioxide (ATO) has improved outcomes but early mortality remains a major challenge. RIF, an oral arsenic compound Chinese patent medicine, has demonstrated efficacy comparable to ATO with advantages in safety and oral administration convenience. Previous smaller studies suggested RIF may accelerate recovery of coagulation parameters and reduce early death. Patients clinically suspected of APL will be randomized into two groups: Experimental group: oral ATRA + RIF before molecular diagnosis confirmation Control group: oral ATRA only before confirmation After molecular or genetic diagnosis confirmation: Experimental group receives 1 week of ATRA + RIF induction (days 0-7…

This description comes directly from the study's public registry record.

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