Chemotherapy-Induced Thrombocytopenia in Leukemia
Conditions
Interventions
Experimental group:If the subject's platelet count is =10×10^9/L, administer romiplostim N01 at a starting dose of 3 µg/kg subcutaneously once weekly. During the trial, if the platelet count exceeds t
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 75 years old (inclusive), regardless of gender. 2. Diagnosis: Histologically or pathologically confirmed diagnosis of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL). 3. Treatment Status: The subject is currently undergoing chemotherapy or targeted therapy with a 28-day cycle and has developed thrombocytopenia due to the anti-tumor treatment. 4. Platelet Count: Patient's platelet count is = 12 weeks, and the patient is expected to receive at least 2 more cycles of the current chemotherapy regimen. 7. Contraception and Pregnancy: Female subjects of childbearing potential must have a negative serum pregnancy test result prior to enrollment and must not be breastfeeding. 8. Informed Consent and Compliance: Capable of understanding the procedures and methods of this clinical trial, voluntarily participates, signs the Informed Consent Form (ICF), and demonstrates good compliance.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of other hematologic diseases, including primary immune thrombocytopenia, primary myeloproliferative disorders (except for leukemia-associated myelofibrosis as judged by the investigator), multiple myeloma, or myelodysplastic syndromes. 2. Other diseases causing thrombocytopenia within 6 months prior to screening, such as chronic liver disease, hypersplenism, or infections, excluding chemotherapy-induced thrombocytopenia (CIT). 3. Brain tumors or brain metastases, or tumor invasion or metastasis to the bone marrow. 4. Prior radiotherapy, especially to long bones or flat bones (e.g., pelvis, sternum), or currently receiving or expected to receive radiotherapy. 5. History of thrombotic tendency or currently receiving thrombolytic/anticoagulant therapy. 6. Any arterial or venous thrombotic events within 6 months prior to screening, including but not limited to cerebrovascular accidents (e.g., transient ischemic attack, cerebral infarction), deep vein thrombosis (excluding untreated muscular vein thrombosis), and pulmonary embolism, except for resolved deep or superficial venous thrombotic events. 7. Severe cardiovascular disease within 6 months prior to screening (e.g., NYHA Class III–IV), arrhythmias that increase thrombotic risk such as atrial fibrillation, or history of coronary stent implantation, angioplasty, or coronary artery bypass grafting. 8. Significant liver dysfunction: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 3 × ULN (upper limit of normal), total bilirubin (TBIL) > 1.5 × ULN (for patients with liver metastases, ALT and AST = 1.5 × ULN or creatinine clearance (CrCL) <= 50 mL/min (calculated using the Cockcroft-Gault formula). 10. Treatment with rhIL-11, rhTPO, or thrombopoietin receptor agonists (e.g., eltrombopag, romiplostim) within 28 days prior to enrollment, or treatment with other drugs affecting platelet function (e.g., aspirin, caffeic acid tablets, leucogen tablets) within 7 days prior to enrollment. 11. Known or expected hypersensitivity or intolerance to the active ingredient or excipients of Romiplostim N01 for injection (including cellulose-lactose, low-substituted hydroxypropyl cellulose, magnesium stearate). 12. Positive hepatitis C antibody with HCV-RNA exceeding the upper limit of the central laboratory test, positive hepatitis B surface antigen with HBV-DNA exceeding the upper limit of the central laboratory test, severe cirrhosis, positive human immunodeficiency virus (HIV) antibody, or active syphilis. 13. Other factors that, in the investigator’s judgment, may affect study results or lead to premature termination of the study, such as alcoholism, drug abuse, substance abuse, other severe diseases (including psychiatric disorders) requiring concurrent treatment, severe laboratory abnormalities, or family or social factors that may compromise medication safety. 14. Other conditions deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of days for platelet count to recover to >=50×10^9/L; | — |
Secondary
| Measure | Time frame |
|---|---|
| ypes, incidence, grading, severity, duration of adverse events (AEs), and their relationship with the investigational drug;Proportion of subjects who experienced dose interruption, dose reduction, or dose discontinuation of the investigational drug due to investigational drug-related toxicity during the study period;The incidence and severity of bleeding events (assessed using the modified WHO bleeding scale), and the incidence and severity of thrombotic events; | — |
Countries
China
Contacts
Public ContactRui Zhang
The First Hospital of China Medical University
Outcome results
None listed