Cancer therapy induced thrombocytopenia
Conditions
Interventions
romiplostim group:Romiplostim will be administered via subcutaneous injection at an initial dose of 3 µg/kg once weekly. If the platelet count remains = 100×10^9/L during the treatment period.
rhTPO group: Recombinant human thrombopoietin (rhTPO) will be administered via subcutaneous injection at a dose of 15,000 U/day once daily for 2 consecutive weeks. Treatment may be discontinued early
Sponsors
The Third People’s Hospital of Chengdu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Voluntarily sign a written informed consent form before enrollment; 2) Aged 18-85 years (inclusive) at the time of signing the informed consent form; 3) Pathologically or cytologically confirmed solid tumor or lymphoma (including non-small cell lung cancer, breast cancer, bladder cancer, pancreatic cancer, etc.), with a chemotherapy cycle of 21 or 28 days, and requiring treatment with one or more of the following chemotherapeutic drugs: antimetabolites (including gemcitabine), platinum-based drugs (including carboplatin, nedaplatin, cisplatin, lobaplatin), anthracyclines (including doxorubicin, daunorubicin, epirubicin), alkylating agents (including cyclophosphamide, ifosfamide), and other cytotoxic chemotherapeutic drugs that can cause thrombocytopenia; 4) Platelet count = 12 weeks at screening; 7) Good compliance, able to complete scheduled follow-up visits and laboratory tests.
Exclusion criteria
Exclusion criteria: 1) Presence of other hematological diseases in addition to chemotherapy-induced CIT, such as primary immune thrombocytopenia, myeloproliferative neoplasms, aplastic anemia, or leukemia; 2) A history of thrombocytopenia caused by non-chemotherapy factors within 6 months before screening, including but not limited to EDTA-dependent pseudothrombocytopenia, hypersplenism (confirmed by imaging), active infection (body temperature > 38.5? confirmed by pathogen detection), and platelet consumption due to severe bleeding (e.g., gastrointestinal bleeding, intracranial bleeding); 3) Bone marrow invasion or bone marrow metastasis confirmed by bone marrow aspiration/biopsy or imaging; 4) History of radiotherapy to the pelvic, spinal, or skeletal regions within 3 months before screening, or planned radiotherapy during the study period; 5) History of severe arterial/venous thrombotic events (e.g., deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebral infarction) within 3 months before screening; 6) Presence of severe cardiovascular diseases at screening, including New York Heart Association (NYHA) Grade III-IV cardiac function, uncontrolled atrial fibrillation, coronary stent implantation/angioplasty/coronary artery bypass grafting within 6 months, or uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg despite drug treatment); 7) Clinical manifestations of severe bleeding (World Health Organization [WHO] Grade >= 2, e.g., persistent gingival bleeding, melena, hematuria) within 2 weeks before the first administration of the study drug; 8) History of platelet transfusion within 3 days before randomization; 9)Use of thrombopoietin receptor agonists (e.g. romiplostim, eltrombopag), recombinant human thrombopoietin (rhTPO), or interleukin-11 (IL-11) within 3 weeks before the first administration of the study drug; 10) History of bone marrow transplantation or hematopoietic stem cell infusion within 1 year before screening; 11) Positive hepatitis B surface antigen (HBsAg) with hepatitis B virus deoxyribonucleic acid (HBV-DNA) > upper limit of normal (ULN); positive hepatitis C antibody (anti-HCV) with hepatitis C virus ribonucleic acid (HCV-RNA) > ULN; positive human immunodeficiency virus (HIV) antibody; or positive syphilis antibody; 12) Severe liver dysfunction: total bilirubin (TBIL) > 3×ULN; alanine transaminase (ALT)/aspartate transaminase (AST) > 3×ULN (for patients without liver metastasis) or > 5×ULN (for patients with liver metastasis); 13) Severe renal dysfunction: serum creatinine (Scr) >= 1.5×ULN or estimated glomerular filtration rate (eGFR, calculated using the Cockcroft-Gault formula) <= 60 mL/min; 14) History of severe allergic reactions (e.g., anaphylactic shock, angioedema) to romiplostim, rhTPO, or their excipients; 15) Participation in clinical studies of other investigational drugs/devices within 1 month before screening; 16) Determined by the investigator to be unsuitable for participation in the study, such as presence of mental illness affecting compliance, or other severe comorbidities that may increase study risks or interfere with efficacy/safety evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vital signs;clinical physical examination;performance status;laboratory tests;adverse events; | — |
Countries
China
Contacts
Public ContactTan jing
The Third People’s Hospital of Chengdu
Outcome results
None listed