acute lymphoblastic leukemia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Ages 1 to 17, any gender; 2.Diagnosed with acute lymphoblastic leukemia via bone marrow cytology, flow cytometry and/or cytogenetics; 3.Patients who achieve complete remission after induction chemotherapy and are scheduled to receive early intensive therapy (or delayed intensive therapy); 4.PLT > 100×10^9/L before initiation of the CAML regimen, and the patient is expected to tolerate and complete the CAML phase of treatment; 5.ECOG score = 2; 6.No obvious abnormalities in liver and kidney function (serum urea nitrogen, creatinine, transaminase and bilirubin are all = 1.5 times the upper limit of normal range); 7.No severe cardiac or pulmonary dysfunction, nor cerebrovascular diseases; 8.No history of mental illness; 9.Expected survival period greater than 3 months; 10.Voluntarily sign the written informed consent form to understand and comply with all research requirements;
Exclusion criteria
Exclusion criteria: 1.History of allergy to rhTPO; 2.History of thrombosis; 3.Thromboembolic or hemorrhagic diseases; 4.Congestive heart failure, arrhythmia, peripheral arteriovenous thrombosis requiring medical treatment at enrollment, or myocardial infarction or cerebral infarction occurring within 3 months prior to enrollment; 5.Failed to complete 80% of the scheduled administration of cytarabine and 6-mercaptopurine due to various reasons (for patients with confirmed homozygous NUDT15 or TPMT deficiency, the completion volume of 6-mercaptopurine shall be calculated after a 50% dosage reduction). 6.With a history of liver cirrhosis or portal hypertension; 7.Received platelet transfusion within 2 days prior to enrollment; 8.Currently suffering from severe or uncontrollable infections; 9.Myelofibrosis is present; 10.Other circumstances under which researchers believe patients are not suitable for participating in this study;
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Time required for platelet count to recover to =100×10^9/L;Incidence of Adverse Events;Median time to platelet count recovery =75×10^9/L;Length of hospital stay;PLT response rates on Day 7 and Day 14 after the initial administration of rhTPO;Minimum value of thrombocytopenia and its onset time; | — |
Primary
| Measure | Time frame |
|---|---|
| Frequency of platelet transfusions and total transfusion dose;PLT response rate on the 10th day after the initial administration of rhTPO; | — |
Countries
China
Contacts
Baoding Hospital of Beijing Children's Hospital Capital Medical University