Optimum Induction Therapy of Low-risk APL

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Despite the high cure probability for acute promyelocytic leukemia (APL), a minority of patients will relapse and the risk factors for relapse are unclear. The goal of this clinical trial is to compare the effectiveness and safety of induction of oral all-trans retinoic acid (ATRA) and realgar-indigo naturalis formula (RIF) combined with oral etoposide or daunorubicin as cytoreductive therapies in low-risk APL. The present study was to explored a cytoreduction of an oral etoposide for low-risk APL with dual induction of ATRA and RIF as a high efficacy, low recurrence, and more convenient all-oral regimen.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital
• Treatments: Daunorubicin; Etoposide; Tretinoin

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.