Optimum Induction Therapy of Low-risk APL

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Apr 26, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the best way to treat patients with a type of blood cancer called acute promyelocytic leukemia (APL), specifically those who are classified as low-risk. The researchers want to find out how effective and safe a new treatment combination is, which includes taking oral medications: all-trans retinoic acid (ATRA), realgar-indigo naturalis formula (RIF), and either etoposide or daunorubicin. The goal is to see if this all-oral approach can help improve treatment outcomes and reduce the chances of cancer coming back.

To participate in this trial, patients need to be newly diagnosed with APL and between the ages of 18 and 75. They also need to meet certain health criteria, such as having normal liver and kidney function. This trial is currently recruiting participants, and those who join can expect to receive close monitoring during treatment to ensure their safety. It's important to note that individuals with specific health issues or who are pregnant cannot participate. If you or a loved one is interested in this trial, discussing it with a healthcare provider can provide more personalized information.

Gender

ALL

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.