NCT06450145 Evaluate the Efficacy and Safety of Interferon-α Combined With ATO in the Treatment of Arsenic-resistant APL
| NCT ID | NCT06450145 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhejiang Provincial People's Hospital |
| Condition | Tumour |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2024-05-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Ping Huang
STUDY CHAIR
Zhejiang Provincial People's Hospital
Frequently Asked Questions
Who can join the NCT06450145 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Tumour. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06450145 currently recruiting?
Yes, NCT06450145 is actively recruiting participants. Contact the research team at hao61977@163.com for enrollment information.
Where is the NCT06450145 trial being conducted?
This trial is being conducted at Hangzhou, China, Hangzhou, China.
Who is sponsoring the NCT06450145 clinical trial?
NCT06450145 is sponsored by Zhejiang Provincial People's Hospital. The principal investigator is Ping Huang at Zhejiang Provincial People's Hospital. The trial plans to enroll 15 participants.