Early use of oral Realgar-Indigo Naturalis plus all-trans retinoic acid for acute promyelocytic leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized controlled trial comparing early induction with oral Realgar-Indigo Naturalis Formula (RIF) plus ATRA against standard approaches that include ATO and ATRA in adults with APL. The trial enrolls newly diagnosed or highly suspected APL patients, including high-risk patients with elevated white blood cell counts. The primary outcome is early death (within 30 days), with secondary outcomes including control of coagulopathy, major bleeding events, and remission rates. Interventions include oral RIF, ATRA, and arsenic trioxide (ATO) as relevant to the assigned treatment arm, with the goal of determining whether early oral RIF can more rapidly stabilize coagulation and reduce hemorrhagic risk.

Why it matters

Who can join: the full rules

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.

Where it's running

• First Affiliated Hospital of Xi'an Jiaotong University
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Study coordinator: Huaiyu Wang
• Email: whymed@126.com
• Phone: +8618991232410

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining Chidamide and Venetoclax for Hard-to-Treat Acute Promyelocytic Leukemia

  This study is testing a new combination of two drugs, chidamide and venetoclax, to see if it can help people with hard-to-treat acute promyelocytic leukemia who haven't responded to standard treatments.

  Recruiting at 2 sites Phase 2 Shanghai Jiao Tong University School of Medicine · Huai'an, Jiangsu and 4 other locations · NCT05881265

• QTX-2101 (oral arsenic) plus ATRA for adults with low- or intermediate-risk APL

  This Phase 3 trial tests whether an oral arsenic capsule (QTX-2101) combined with ATRA works well and is safe for adults aged 18–70 with newly diagnosed low- or intermediate-risk acute promyelocytic leukemia.

  Recruiting at 36 sites Phase 3 Quetzal Therapeutics · Birmingham, Alabama and 35 other locations · NCT07504458

• Combining oral arsenic and ATRA for treating newly diagnosed acute promyelocytic leukemia

  This study is testing if a new treatment combining oral arsenic and ATRA can help newly diagnosed patients with acute promyelocytic leukemia live longer and feel better, especially those at high risk.

  Recruiting Phase 2 Instituto do Cancer do Estado de São Paulo · São Paulo, São Paulo · NCT06982274

• Using sirolimus to treat thrombocytopenia related to antiphospholipid antibodies

  This study is testing if the medication sirolimus can help people with low platelet counts caused by antiphospholipid antibodies feel better compared to those who receive a placebo.

  Recruiting at 10 sites Phase 4 Peking University First Hospital · Changsha, Hunan and 9 other locations · NCT06722586

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.