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

Tumour Clinical Trial

— APL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06450145
• Other study ID #: YJKY20230026
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Zhejiang Provincial People's Hospital
• Contact: Rui Hao
• Phone: 15957145619
• Email: hao61977[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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-RARa) 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.

Exclusion Criteria:

• 1. Allergy or contraindication to any study drug involved in the protocol;

• 2. Physical examination, electrocardiogram, laboratory examination, vital signs and test related abnormalities are clinically significant (subject to clinician's judgment);

• 3. Other serious conditions that may limit the patient's participation in the trial, such as severe liver or kidney disease; "Patients with advanced infection, uncontrolled diabetes mellitus, severe cardiac dysfunction (e.g., clinically significant prolongation of the QT interval, potentially fatal torsades de pointes) or a history of angina or major heart disease, autoimmune diseases (as judged by the clinician);"

• 4. Pregnant or lactating women;

• 5. Epilepsy and central nervous system dysfunction;

• 6. Active hepatitis B, active hepatitis A, HIV positive;

• 7. Participate in other clinical trials at the same time

• 8. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.

Related Conditions & MeSH terms

• Tumour

Intervention

Drug:
• interferon a-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 a-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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang Provincial People's Hospital	First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Efficacy: objective remission rate	4 to 6 weeks
Secondary	Adverse Events	Safety: the incidence and severity of adverse events were evaluated according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 5.0).	Through study completion, an average of 1 year
Secondary	DFS	disease free survival	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
Secondary	OS	overall survival	From date of randomization until the date of date of death from any cause, assessed up to 5 years