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Evaluate the Efficacy and Safety of Interferon-α Combined With ATO in the Treatment of Arsenic-resistant APL

NCT06450145 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-06-10

No results posted yet for this study

Summary

This study was a single-arm, open study. After the screening period, arsenic-resistant APL patients were treated with interferon α-2b, arsenic and venetoclax. The efficacy (ORR) and safety were evaluated.

Conditions

  • Tumour

Interventions

DRUG

interferon α-2b

Eligible APL patients with arsenic-resistant relapse will enter the run-in period, and the subjects in the run-in phase will be treated with arsenic combined with venetoclax. After the run-in period, the patients were treated with interferon α-2b, arsenic trioxide for injection and venetoclax until the outcome of CR/PR/PD/ death/withdrawal/loss to follow-up occurred. Tumor assessments were performed every 4 to 6 weeks (as determined by the investigator) during trial treatment. Those who achieved CR/PR/PD/ withdrawal were then returned to standard treatment (treatment regimen was determined by the clinician), and those who completed the combination treatment period of the trial entered the survival follow-up period.

Sponsors & Collaborators

  • First Affiliated Hospital of Zhejiang University

    collaborator OTHER

  • Zhejiang Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Ping Huang · Zhejiang Provincial People's Hospital

  • Xiaogang Wang · Zhejiang Provincial People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06450145 on ClinicalTrials.gov