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

Recruitment & Eligibility

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.
1. Age 18-70 years old (including boundary value);
1. 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);
1. 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;
1. Eastern Cooperative Oncology Group (ECOG) performance status score 0-2;
1. The expected survival time is more than 3 months.

Exclusion Criteria

1. Allergy or contraindication to any study drug involved in the protocol;
1. Physical examination, electrocardiogram, laboratory examination, vital signs and test related abnormalities are clinically significant (subject to clinician's judgment);
1. 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);"
1. Pregnant or lactating women;
1. Epilepsy and central nervous system dysfunction;
1. Active hepatitis B, active hepatitis A, HIV positive;
1. Participate in other clinical trials at the same time
1. 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.

Study & Design

Arm && Interventions

Group	Intervention	Description
interferon α-2b	interferon 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

Primary Outcome Measures

Name	Time	Method
ORR	4 to 6 weeks	Efficacy: objective remission rate

Secondary Outcome Measures

Name	Time	Method
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

Recruitment & Eligibility