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

RecruitingPhase 3Ages 18 Years - 80 YearsAllFirst Affiliated Hospital Xi'an Jiaotong Universi…
NCT07503730 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age between 18 and 80 years. 2. Diagnosed with acute myeloid leukemia confirmed by bone marrow morphology and immunophenotyping, with a high clinical suspicion of acute promyelocytic leukemia (APL). Exclusion Criteria: 1. Confirmed non-APL (M3 type) acute myeloid leukemia through cytogenetic and RT-PCR testing (PML-RARα fusion gene negative). 2. Severe liver or kidney dysfunction unrelated to APL (e.g., serum creatinine \> 2.5 times the upper limit of normal, total bilirubin ≥ 2 times the upper limit, ALT and AST \> 3 times the upper limit), or heart failure (e.g., EF \< 40%). 3. Presence of other malignancies. 4. Pregnant or breastfeeding women.
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What it tests

  • ATRA
  • RIF
  • ATO
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Where

1 site
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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