A Study to Explore the Efficacy and Safety of Interferon-α Combined With ATO and Venetoclax in the Treatment of Arsenic-resistant Acute Promyelocytic Leukemia

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 1. Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.

• 2. Age 18-70 years old (including boundary value);

• 3. The presence of promyelocytic leukemia-retinoic acid receptor alpha (PML-RARα) confirmed by morphological features, cytogenetic analysis, and real-time quantitative polymerase chain reaction (qPCR);

• 4. Arsenic relapse resistant patients: patients who had relapsed (including molecular relapse) after remission with ATO in the previous treatment, and could not be relieved after standard treatment;

• 5. Eastern Cooperative Oncology Group (ECOG) performance status score 0-2;

• 6. The expected survival time is more than 3 months.

Locations
Other Locations
China
First Affiliated Hospital of Zhejiang University
RECRUITING
Hangzhou
Zhejiang Provincial People's Hospital
RECRUITING
Hangzhou
Contact Information
Primary
Rui Hao
hao61977@163.com
15957145619
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 15
Treatments
Experimental: 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
Sponsors
Leads: Zhejiang Provincial People's Hospital
Collaborators: First Affiliated Hospital of Zhejiang University

This content was sourced from clinicaltrials.gov