Comparing oral therapies for low-risk acute promyelocytic leukemia

Optimum Induction Therapy of Low-risk Acute Promyelocytic Leukemia With All Oral Drugs

This study is testing a new all-oral treatment for low-risk acute promyelocytic leukemia to see if it helps patients stay in remission and makes it easier for them to take their medicine.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Peking University People's Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05832320 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of an all-oral induction therapy regimen for low-risk acute promyelocytic leukemia (APL) using all-trans retinoic acid (ATRA) and realgar-indigo naturalis formula (RIF) combined with oral etoposide or daunorubicin. The study focuses on reducing the risk of relapse and improving convenience for patients by utilizing oral medications. It seeks to explore the prognostic significance of cytoreduction during induction therapy and its impact on treatment outcomes. Participants will be newly diagnosed APL patients aged 18-75 who meet specific health criteria.

Who should consider this trial

Good fit: Ideal candidates for this study are newly diagnosed APL patients aged 18-75 with specific liver and renal function criteria.

Not a fit: Patients who are pregnant, lactating, or have severe comorbidities such as HIV or viral hepatitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and convenient treatment option for patients with low-risk acute promyelocytic leukemia.

How similar studies have performed: Previous studies have shown promising results with similar approaches in high-risk APL, but this specific regimen is novel.

Eligibility criteria

Inclusion Criteria:

* Newly diagnosed APL patients (WHO 2008 diagnostic classification);
* 18-75 years old;
* Liver function: propionate hydrogentransferase (ALT) and aspartate hydrogentransferase (AST) ≤ 2.5 times the upper limit of normal value, bilirubin ≤ 2 times the upper limit of normal value;
* Renal function: muscle salt ≤ 3 times the upper limit of normal value;
* The physical strength score is 0-2 (ECOG);
* White blood cells ≤ 10×109/L;
* Subjects must sign an informed consent form.

Exclusion Criteria:

* Subjects who have participated in other clinical trials within 30 days;
* Pregnant and lactating subjects;
* Subjects who are known to be HIV-positive in serological tests;
* Subjects who have viral hepatitis serological test positive;
* Subjects who have severe arrhythmia, abnormal electrocardiogram (QT\>500ms);
* Subjects who suffer from mental illness or unable to cooperate with the research treatment and monitoring requirements due to other diseases;
* Subjects who participate in other clinical research at the same time;
* Subjects who fail to sign the informed consent form;
* Other conditions that the researchers think are not suitable for inclusion.

Where this trial is running

Beijing, Beijing Municipality

• Peking University Institute of Hematology — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Xiaolu Zhu, Doctor — Peking University People's Hospital
• Study coordinator: Xiaolu Zhu, Doctor

Conditions: Acute Promyelocytic Leukemia, Induction Therapy, Oral, low risk, induction therapy, etoposide