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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Peking University Institute of Hematology
RECRUITING
Beijing
Contact Information
Primary
Xiaolu Zhu, Doctor
zhuxl0614@163.com
8610-82816999
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 74
Treatments
Experimental: Oral etoposide with dual induction of ATRA and RIF
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.
Active_comparator: Daunorubicin with dual induction of ATRA and RIF
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).
Sponsors
Leads: Peking University People's Hospital

This content was sourced from clinicaltrials.gov

Similar Clinical Trials