Cancer therapy induced thrombocytopenia
Conditions
Interventions
Sponsors
Henan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Signed written informed consent before enrollment; (2) age range from 18 to 75 years old; (3) Confirmed lymphoma and myeloma; (4) anti-tumor therapy for CTIT patients; (5) Have not received ropractim/ropristom N01 treatment; (6) ECOGPS score: 0-2; (7) Total bilirubin <=1.5xULN, except for Gilbert syndrome, or other conditions that do not indicate hepatic insufficiency (such as indirect bilirubin (hemolysis) elevation in the absence of alanine aminotransferase [ALT] abnormalities). ALT <=3xULN. serum creatinine <=2.5xULN; (8) Subjects of childbearing age agree to use reliable contraceptive measures (including male or female condoms, contraceptive foam, contraceptive gel, contraceptive film, contraceptive cream, contraceptive suppositories, abstinence and intrauterine device placement, etc.) throughout the study period; Female participants who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation, or more than 1 year postmenopausal, as well as male participants who have undergone bilateral salpingectomy or ligation, were excluded.
Exclusion criteria
Exclusion criteria: (1) Thrombocytopenia caused by reasons other than CTIT, including but not limited to chronic liver disease, hypersplenism, infection, and bleeding within 6 months prior to screening; (2) History of severe cardiovascular disease within 6 months prior to screening, such as congestive heart failure (NYHA Cardiac Function Score III-IV), cardiac arrhythmias known to increase the risk of thromboembolism, such as atrial fibrillation, coronary artery stenting, angioplasty, and coronary artery bypass grafting; (3) Any history of arterial or venous thrombosis within 6 months prior to screening; (4) Clinical manifestations of severe bleeding within two weeks prior to screening, such as gastrointestinal or central nervous system bleeding; (5) requiring emergency treatment, such as vena cava syndrome and spinal cord compression syndrome; (6) The absolute value of neutrophils <0.5×109/L, hemoglobin < 60g/L, and the use of granulocyte colony-stimulating factor and erythrocyte EPO infusion in line with clinical specifications is allowed; (7) Receiving platelet transfusion within 3 days prior to enrollment; (8) Patients with known or predicted allergy or intolerance to roprlastim N01; (9) Known active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection; (10) Pregnant or lactating women; (11) Participated in any clinical study of any other investigational drug or device in the three months prior to screening; (12) In the opinion of the investigators, participation in the trial poses a significant risk to the health or safety of the subject, or other circumstances that may affect the evaluation of efficacy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who produce an efficacy response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients receiving platelet transfusions;Median time to reach platelet count =50×109/L; | — |
Countries
China
Contacts
Public ContactZhen Wang
Henan Provincial People's Hospital
Outcome results
None listed