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RECRUITING
NCT05832320
NA

Optimum Induction Therapy of Low-risk APL

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

74

Start Date

2023-01-01

Completion Date

2024-12-31

Last Updated

2024-05-10

Healthy Volunteers

No

Interventions

DRUG

Etoposide

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.

DRUG

Daunorubicin

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