Recruiting PHASE3 APL

New treatment option for APL

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

ClinicalTrials.gov ID: NCT07503730

What this study is testing

What is ATRA?

ATRA is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for apl.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 3: a large, late-stage study
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 80

You may be able to join if

  • Age between 18 and 80 years.
  • Diagnosed with acute myeloid leukemia confirmed by bone marrow morphology and immunophenotyping, with a high clinical suspicion of acute...

You likely can't join if

  • Confirmed non-APL (M3 type) acute myeloid leukemia through cytogenetic and RT-PCR testing (PML-RARα fusion gene negative).
  • 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...
  • Presence of other malignancies.
  • Pregnant or breastfeeding women.

The study team makes the final eligibility decision.

Where it's taking place

  • Xi'an, Shaanxi, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Xi'an, Shaanxi, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.