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

Launched by ZHEJIANG PROVINCIAL PEOPLE'S HOSPITAL · Jun 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with a type of blood cancer called acute promyelocytic leukemia (APL) who have not responded to traditional arsenic-based therapies. The treatment combines three medications: interferon α-2b, arsenic, and venetoclax. Researchers want to find out how effective this combination is at helping patients achieve remission and whether it is safe to use.

To be eligible for this trial, participants must be between 18 and 70 years old and have a specific genetic marker related to APL. They should have previously experienced a relapse after treatment with arsenic and not responded to standard therapies. It's important that participants are in relatively good health, with a good performance status score, and have an expected survival time of more than three months. As with any clinical trial, there are specific criteria that could exclude individuals, such as certain serious health conditions or ongoing participation in other trials. If eligible, participants can expect close monitoring throughout the study to assess their response to the treatment and any side effects.

Gender

ALL

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.