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| Name | Class |
|---|---|
| First Affiliated Hospital of Zhejiang University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Efficacy: objective remission rate | 4 to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | 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). | Through study completion, an average of 1 year |
| DFS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui Hao | Contact | 15957145619 | hao61977@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ping Huang | Zhejiang Provincial People's Hospital | Study Chair |
| Xiaogang Wang | Zhejiang Provincial People's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310014 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007438 | Introns |
| D000077237 | Arsenic Trioxide |
| C579720 | venetoclax |
| ID | Term |
|---|---|
| D021901 | DNA, Intergenic |
| D040481 | Genome Components |
| D016678 | Genome |
| D040342 | Genetic Structures |
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|
disease free survival |
| 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 | overall survival | From date of randomization until the date of date of death from any cause, assessed up to 5 years |
| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | Zhejiang | 310014 | China |
|
| D055614 |
| Genetic Phenomena |
| D040461 | Gene Components |
| D005796 | Genes |
| D001152 | Arsenicals |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |