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

NCT06450145 | Recruiting

• 1 other identifier: YJKY20230026
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Tumour

Keywords

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

Outcome Measures

Primary Outcomes (1)

• ORR

  Efficacy: objective remission rate

  4 to 6 weeks

Secondary Outcomes (3)

• Adverse Events

  Through study completion, an average of 1 year

• DFS

  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

• OS

  From date of randomization until the date of date of death from any cause, assessed up to 5 years

Study Arms (1)

interferon α-2b

EXPERIMENTAL

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

Drug: interferon α-2b

Interventions

interferon α-2b DRUG

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.

Also known as: arsenic trioxide, venetoclax

interferon α-2b

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. Age 18-70 years old (including boundary value);
• \. 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);
• \. 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;
• \. Eastern Cooperative Oncology Group (ECOG) performance status score 0-2;
• \. The expected survival time is more than 3 months.

You may not qualify if:

• \. Allergy or contraindication to any study drug involved in the protocol;
• \. Physical examination, electrocardiogram, laboratory examination, vital signs and test related abnormalities are clinically significant (subject to clinician's judgment);
• \. 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);"
• \. Pregnant or lactating women;
• \. Epilepsy and central nervous system dysfunction;
• \. Active hepatitis B, active hepatitis A, HIV positive;
• \. Participate in other clinical trials at the same time
• \. 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.

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead
• First Affiliated Hospital of Zhejiang University: collaborator

Study Sites (2)

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310014, China

RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Introns; Arsenic Trioxide; venetoclax

Intervention Hierarchy (Ancestors)

DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes; Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds

Study Officials

• Ping Huang

  Zhejiang Provincial People's Hospital

  STUDY CHAIR

• Xiaogang Wang

  Zhejiang Provincial People's Hospital

  STUDY CHAIR

Central Study Contacts

Rui Hao

CONTACT

15957145619; hao61977@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: June 10, 2024
• Study Start: May 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)