Tumour
Conditions
Keywords
APL, arsenic-resistant relapse, interferon α-2b
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.
Detailed 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.
Interventions
DRUGinterferon α-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 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.
Sponsors
First Affiliated Hospital of Zhejiang University
Zhejiang Provincial People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 4 to 6 weeks | Efficacy: objective remission rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Through study completion, an average of 1 year | 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). |
| 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 | disease free survival |
| OS | From date of randomization until the date of date of death from any cause, assessed up to 5 years | overall survival |
Countries
China
Contacts
Primary ContactRui Hao
Outcome results
None listed