acute promyelocytic leukemia,APL
Conditions
Interventions
experimental group:Ven reduces white blood cells.
control group:Chemotherapy drugs reduce white blood cells.
Sponsors
Linyi People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years or older, regardless of gender; 2. Diagnosed with acute promyelocytic leukemia (APL) through bone marrow cell morphology, immunophenotype, cytogenetics and molecular biology tests, with positive PML-RARa fusion gene (including classic and variant types); 3. During induction therapy, peripheral blood white blood cell count (WBC) > 4×10^9/L, and clinical need to initiate leukopenia treatment; 4. Eastern Cooperative Oncology Group (ECOG) performance status score 0-2, able to tolerate study-related treatment and examinations; 5. Expected survival time >= 3 months; 6. No severe failure of coagulation function, liver and kidney function (liver function: ALT/AST = 3× upper limit of normal (ULN), total bilirubin = 60 ml/min; coagulation function: no uncorrectable severe bleeding tendency); 7. Before enrollment, the study content, benefits and potential risks have been fully informed, and the subject or their legal representative voluntarily signed the written informed consent form; 8. Able to cooperate with the entire course of treatment, examination and follow-up in the study, with good compliance.
Exclusion criteria
Exclusion criteria: 1. Patients with peripheral blood WBC 3×ULN, or total bilirubin > 1.5×ULN and accompanied by complications such as hepatic encephalopathy); (2) Renal failure (serum creatinine > 1.5×ULN, or endogenous creatinine clearance rate = 3, or left ventricular ejection fraction (LVEF) 1×10^3IU/ml, or HCV RNA positive; 7. Patients with prolonged QT interval (corrected QT interval (QTc) > 470ms (female) / 450ms (male)), or those with a family history of long QT syndrome, or those currently using drugs that are known to prolong the QT interval and cannot be discontinued; 8. Pregnant or lactating women, or men and women of childbearing age who are unwilling to take effective contraceptive measures during the study and within 6 months after treatment; 9. Patients with mental illness, cognitive impairment, or other reasons that prevent them from cooperating with informed consent, treatment, and follow-up; The investigator determines that there are other situations that make the patient unsuitable for enrollment (such as a history of drug abuse, extremely poor compliance, or family and social factors that cannot support the entire study process, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Observe the rate of WBC decline and the peak value control (the proportion of WBC dropping to < 4×10^9/L within 7 days); | — |
Secondary
| Measure | Time frame |
|---|---|
| length of hospital stay;hospitalization expenses;Number of platelet transfusions; | — |
Countries
China
Contacts
Public ContactLi Hongli
Linyi People's Hospital
Outcome results
None listed