RecruitingNot ApplicableNCT05832320

Optimum Induction Therapy of Low-risk APL

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


Sponsor

Peking University People's Hospital

Enrollment

74 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is looking for the best induction (initial) treatment approach for people newly diagnosed with low-risk acute promyelocytic leukemia (APL), a type of blood cancer that tends to respond well to treatment. Researchers want to compare different treatment combinations to find the safest and most effective option. **You may be eligible if...** - You have been newly diagnosed with APL (a specific type of leukemia) - You are between 18 and 75 years old - Your liver and kidney function are within acceptable limits - Your white blood cell count is not too high at diagnosis - Your overall health allows you to tolerate treatment (ECOG score 0–2) **You may NOT be eligible if...** - You have HIV, active hepatitis B or C, or a serious heart rhythm problem - You are pregnant or breastfeeding - You have a serious mental illness that would affect your ability to participate - You are already enrolled in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEtoposide

Introduction: RIF: 60mg/kg qd, ATRA: 25mg/m2 qd, till CR. When WBC\>4.0×109/L, patients will be given oral etoposide (50mg qd to 50mg tid). Cumulative dosage of etoposide during induction ≤1500mg.

DRUGDaunorubicin

Introduction: RIF: 60mg/kg qd, ATRA: 25mg/m2 qd, till CR. When WBC\>4.0×109/L, patients will be given daunorubicin (20 to 40mg per dose).


Locations(1)

Peking University Institute of Hematology

Beijing, Beijing Municipality, China

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NCT05832320


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