Acute promyelocytic leukemia
Conditions
Interventions
research group:ruxolitinib and dexamethasone
Sponsors
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
14 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1: Newly diagnosed classic type of high-risk APL patients confirmed by molecular biology (Sanz risk stratification) 2: Age 14-75 years old 3: Normal liver and kidney function: blood bilirubin = 50%, and no previous history of acute or chronic cardiac insufficiency 5: ECOG score 0-4 (WHO standard) 6: Obtaining informed consent signed by the patient or family member 7: Able to adhere to and cooperate with research interventions, including intravenous and oral medication 8: Women of reproductive age should take contraception methods for at least one month before screening, and promise to avoid pregnancy throughout the entire study period and continue until the specified time after the end of the study
Exclusion criteria
Exclusion criteria: 1: Low risk APL patients (Sanz risk stratification) 2: Recurrent APL patients 3: Variant type APL patients (molecular biology non PML/RARa Patient) 4: Identified central nervous system involvement APL patients 5: Allergy to any study drug involved in the protocol 6: Significant abnormalities in liver and kidney function, exceeding the entry criteria 7: Severe heart disease, including myocardial infarction and cardiac insufficiency 8: Electrocardiogram (EKG) results: QTc interval greater than 450 milliseconds 9: Simultaneously suffering from other organ malignancies 10: Active period of tuberculosis patients and human immunodeficiency virus (HIV) positive patients 11: Unable to understand or follow the research protocol 12: Patients under 14 years old or over 75 years old 13: Pregnant or lactating women 14: Contraindications to anthracycline chemotherapy 15: Existence of drug addiction or mental illness 16: Participating in other clinical researchers during the same period 17: Various situations that hinder research progress
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differentiation syndrome rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Molecular remission rate;Early death rate;Hematological remission rate;Overall survival;Disease free survial; | — |
Countries
China
Contacts
Public ContactShen Yang
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed