cancer treatment-induced thrombocytopenia
Conditions
Interventions
Grade 4 thrombocytopenia:Leflunomide N01 recommended starting dose is 4 µg/kg, administered subcutaneously. The maximum dosage is 10 µg/kg once a week.
Patients with Grade 3 and Grade 2 thrombocytopenia:Eltrombopag NO1 recommended starting dose is 3 µg/kg, administered subcutaneously. The maximum dosage is once a week at 10 µg/kg.
Control group:Patients choose treatments such as platelet transfusion, interleukin-11, or thrombopoietin selected by researchers
Sponsors
Yidu Central Hospital of Weifang City
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 75 (inclusive), gender is not restricted; 2.Histologically or pathologically confirmed solid tumors or hematological malignancies; 3.Patients with confirmed thrombocytopenia caused by anti-tumor treatment, including those with grade 4, grade 3, and grade 2 whose treatment is ineffective (the effect of conventional platelet-raising treatment is ineffective after 5 consecutive days of use [ineffective: the increase compared to the baseline is less than 30%]); 4.ECOG 0-2; 5.Expected survival >=12 weeks; and expected to be able to receive the current anti-tumor treatment regimen (chemotherapy or ADC drugs, which can be combined with targeted therapy and immunotherapy) for >=1 cycle. 6.Subjects of childbearing age should agree to take reliable contraceptive measures throughout the study period; female subjects who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation or have been post - menopausal for more than 1 year and male subjects who have undergone bilateral vasectomy or ligation are excluded; 7.Voluntarily participate in the research and sign the informed consent form, and be able to comply with various requirements of the clinical trial (such as scheduled visits and other trial procedures); 8.Subjects judged by the researcher to be eligible for enrollment;
Exclusion criteria
Exclusion criteria: 1.Subjects with a history of newly developed arterial or deep vein thrombosis within 6 months; 2.Screen for cases of thrombocytopenia caused by reasons other than chemotherapy drugs within the previous six months, including but not limited to chronic liver disease, hypersplenism, and infection; 3.Suffering from hematopoietic system diseases, including but not limited to aplastic anemia, leukemia, primary immune thrombocytopenia, myelodysplastic syndrome, multiple myeloma, etc; 4.Require urgent treatment, such as vena cava syndrome and spinal cord compression syndrome; 5.Abnormal liver function, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of the normal reference range (in patients without liver metastases) or 5 times (in patients with liver metastases); 6.Renal function abnormality, defined as serum creatinine = 1.5 times the upper limit of the normal reference range or eGFR <= 60 ml/min; 7.Screen patients who received romiplostim treatment within the previous month; 8.Received platelet transfusion therapy within 1 week before enrollment; 9.Pregnant or lactating women; 10.Those who are allergic to the test drug or its ingredients; 11.Subjects who participated in other drug clinical trials or interventional studies within the past month; 12.Other conditions judged by the researcher as unsuitable for enrollment in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Thrombocytopenia treatment is effective;Safety indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Platelet Count Achievement Rate; | — |
Countries
China
Contacts
Public ContactPeng Wang
Yidu Central Hospital of Weifang City
Outcome results
None listed