Chemotherapy-induced thrombocytopenia
Conditions
Interventions
Experimental Group:Patients received treatment with Romiplostim N01, with an initial dose of 3 µg/kg, administered subcutaneously once a week. Romiplostim N01 was initiated within 6 to 24 hours after
Sponsors
Jiangxi Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with non-Hodgkin's lymphoma (including diffuse large B-cell lymphoma, follicular lymphoma, NK/ T-cell lymphoma, etc.) aged 18 years or older are eligible, regardless of gender. 2.The tissue or cytological diagnosis clearly indicates a malignant tumor. 3. Expected survival period >=3 months; 4. ECOG score >=2 points; 5.There are no contraindications to chemotherapy, and at least >=1 cycle of chemotherapy treatment has been received, with at least >=2 remaining planned chemotherapy cycles. 6.In the previous chemotherapy cycle (the XTH cycle), the lowest platelet count was less than 50×10^9/L or less than 75×10^9/L, accompanied by at least one high-risk bleeding risk factor, and the same chemotherapy regimen was planned to continue in the (X+1) cycle (the dose adjustment of the chemotherapy regimen did not exceed +/-10%); 7.One week before enrollment, the organ function levels met the following criteria: 1) Blood routine Neutrophil count >=1.5 × 10^9/L; Platelet count >=100 × 10^9/L; Hemoglobin >=8.0g/dL White blood cell count >=4.0×10^9/L; 2) Liver and kidney functions Serum total bilirubin (TBIL) =50 ml/min (Cockcroft-Gault formula); 3) Normal coagulation function, no active bleeding or thrombotic diseases (International normalized ratio INR, partial thromboplastin time APTT, prothrombin time PT<=1.5ULN); 4) Cardiac function: No myocardial infarction occurred within one year; Unstable angina pectoris Severe arrhythmia without symptoms; New York Heart Function Classification I to II. 8.To assess whether there was a definite application of a certain chemotherapy drug that could cause thrombocytopenia in the previous chemotherapy cycle, and after drug withdrawal, the symptoms and signs caused by thrombocytopenia gradually alleviated or the platelet count returned to normal. Other causes of thrombocytopenia need to be ruled out, especially the underlying diseases and complications, such as aplastic anemia, acute leukemia, radiation sickness, immune thrombocytopenia, hypersplenism and infiltration of bone marrow tumor cells, etc. Exclusion of EDTA (ethylenediaminetetraacetic acid, EDTA) anticoagulant, heparin caused by pseudo thrombocytopenia, etc. 9. The patient voluntarily participated in this study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with active bleeding; 2. Patients with thromboembolic or hemorrhagic disorders, or with a recent history of thrombosis; 3. Patients with refractory or difficult-to-correct thrombocytopenia; 4. Patients with concurrent malignancies (except for carcinoma in situ, adequately treated non-melanoma skin cancer and papillary thyroid carcinoma); 5. Patients with known hypersensitivity or allergy to the active substances contained in this product, any excipients or any Escherichia coli-derived products; 6. Patients who are unable to cooperate or refuse treatment; 7. Patients undergoing radiotherapy or chemotherapy; 8. Pregnant or lactating women, or those who cannot take contraceptive measures during the study period; 9. Other conditions where the investigator deems the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with grade III-IV thrombocytopenia in the X+1 cycle; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients whose next chemotherapy cycle (i.e., the X+2 cycle) was delayed by >=4 days or the dose was reduced by >=15% due to platelet count;The proportion of patients with recurrent thrombocytopenia (Cycle X + 1);Platelet transfusion volume; | — |
Countries
China
Contacts
Public ContactWuping Li
Jiangxi Cancer Hospital
Outcome results
None listed