Treatment of arsenic-resistant APL with interferon-α and venetoclax

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

This study is testing a new treatment combining interferon, arsenic, and venetoclax to see if it helps people with arsenic-resistant acute promyelocytic leukemia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Zhejiang Provincial People's Hospital (Academic / other)
• Locations: 2 sites (Hangzhou, Zhejiang and 1 other locations)
• Trial ID: NCT06450145 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of a treatment regimen combining interferon α-2b, arsenic trioxide, and venetoclax in patients with arsenic-resistant acute promyelocytic leukemia (APL). Eligible patients will undergo a run-in period with arsenic and venetoclax before receiving the full treatment. Tumor assessments will be conducted every 4 to 6 weeks to monitor response to the therapy. The study aims to determine the overall response rate and safety profile of this combination therapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with confirmed arsenic-resistant APL who have not responded to standard treatments.

Not a fit: Patients with allergies to any study drugs or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with arsenic-resistant APL.

How similar studies have performed: Other studies have shown promise in using combination therapies for APL, but this specific approach is novel.

Eligibility criteria

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-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.

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.

Where this trial is running

Hangzhou, Zhejiang and 1 other locations

• First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Rui Hao

Conditions Tumour; APL; arsenic-resistant relapse; interferon α-2b