Romiplostim N01 for Chemotherapy-induced Thrombocytopenia

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Jul 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medicine called Romiplostim N01 to see if it can help people who have low platelet counts caused by chemotherapy. Platelets are cells in the blood that help stop bleeding, and chemotherapy can sometimes lower these numbers too much, making it hard for the body to heal and increasing the risk of bleeding. This study is looking at whether Romiplostim N01 is safe and effective for patients whose platelet counts have remained very low despite other treatments.

To join the trial, participants need to be adults (18 years or older) who have had chemotherapy and still have low platelets (less than 30×10⁹/L) for at least a month, even after trying other treatments. They should have stopped chemotherapy and radiation for over a month and be generally healthy enough to join, with no serious heart, liver, or kidney problems. People with active infections, recent blood clots, or certain other serious conditions won’t be eligible. Those who participate will receive Romiplostim N01, and doctors will closely monitor their platelet levels and overall health to see how well the treatment works and if it causes any side effects. If you or a loved one fits these criteria and are interested, this study may offer a new option for managing low platelets after chemotherapy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age: 18 years or above, gender not restricted;
• • Patients who meet the diagnostic criteria for chemotherapy-related thrombocytopenia, and still ineffective after repeated treatment with rhTPO or IL-11 (subjects need to undergo regular rhTPO treatment for at least 14 days after radiotherapy and chemotherapy, with a dose of rhTPO 300u/kg/d or higher, and the platelet count remains less than 30×10\^9/L, defined as refractory CTIT);
• • Patients who have stopped chemotherapy and radiotherapy for more than 1 month;
• • Patients with platelet count at enrollment \< 30×10\^9/L;
• • Patients with platelet count remains \< 30×10\^9/L for more than 1 month;
• • Patients with expected survival period ≥ 6 months;
• • Patients with liver and kidney function \< 1.5× upper limit of normal value, physical examination qualified;
• • Patients with ECOG physical status score ≤ 2 points;
• • Patients with Cardiac function: New York Heart Association cardiac function classification is grade 2 or below;
• • Patients who is voluntary to sign the informed consent form;
• Exclusion Criteria:
• • Those with uncontrollable primary diseases of important organs, such as extensive metastasis of malignant tumors, liver failure, heart failure, kidney failure and other diseases；
• • Patients with poor compliance;
• • Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and/or hepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA, Cytomegalovirus DNA;
• • Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage, etc.
• • There is currently a heart disease requiring treatment or a poorly controlled hypertension judged by the investigator；
• • Patients with thrombotic diseases such as pulmonary embolism, thrombosis, and atherosclerosis；
• • Those who have received allogeneic stem cell transplantation or organ transplantation in the past；
• • Patients with mental disorders who cannot normally obtain informed consent and undergo trials and follow-up；
• • Patients whose toxic symptoms caused by treatment before participating in the trial have not disappeared；
• • Other serious diseases that may restrict participants from participating in this trial (such as diabetes; severe heart failure; myocardial obstruction or unstable arrhythmia or unstable angina in the past 6 months; gastric ulcers; mobility Autoimmune diseases, etc.)；
• • Patients with sepsis or patients with other irregular bleeding；
• • Patients taking antiplatelet drugs at the same time；
• • Pregnant women, suspected pregnancy (a positive pregnancy test for human chorionic gonadotropin in urine at screening) and breastfeeding patients； Pre-existing cardiac disease, including congestive heart failure of New York Heart Association \[NYHA\] Grade III/IV, arrhythmia requiring treatment or myocardial infarction within the last 6 months. No arrhythmia known to increase the risk of thrombotic events (e.g. atrial fibrillation), or patients with a QT \>450msec or QTc \> 480 for patients with a Bundle Branch Block;
• • Researchers believe that patients should not participate in the test of any other condition.