Actively Recruiting
Romiplostim N01 for Chemotherapy-induced Thrombocytopenia in Tumors: a Prospective Multi-center One-arm Study
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-07-14
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
T
Tianjin Medical University Cancer Institute and Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Romiplostim N01 for treating chemotherapy-induced thrombocytopenia (CIT) in tumor patients. This is a Phase 2, single-arm study involving patients who have previously been treated with recombinant human thrombopoietin (rhTPO) or interleukin 11 (IL-11) but did not reach the effective platelet count. The study compares Romiplostim N01 outcomes with historical data on supportive treatment and Eltrombopag to better understand its potential benefits and risks. Participants will receive Romiplostim N01 subcutaneously once a week, starting at 2-3 µg/kg with dose adjustments up to 10 µg/kg depending on platelet response. The dose can be reduced if platelet counts return to normal. The treatment period includes monitoring platelet counts weekly for up to 24 weeks. A total of 50 participants will be enrolled and treated with Romiplostim N01 following this dosing regimen. Throughout the study, researchers will assess changes in platelet counts weekly, bleeding severity using the WHO bleeding scale, and any adverse events for up to 24 weeks. Safety visits will occur weekly for 4 weeks after treatment ends or if a participant withdraws. The main outcome measure is treatment efficiency after 12 weeks, with additional evaluations at 24 weeks. Participants are expected to have stopped chemotherapy and radiotherapy for at least one month prior and meet several health criteria for inclusion.
CONDITIONS
Brief Title
Romiplostim N01 for Chemotherapy-induced Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or above, any gender
- Diagnosed with chemotherapy-related thrombocytopenia, refractory to repeated rhTPO or IL-11 treatments
- Stopped chemotherapy and radiotherapy for more than 1 month
- Platelet count below 30 x 10^9/L at enrollment
- Platelet count remains below 30 x 10^9/L for over 1 month
- Expected survival period of at least 6 months
- Liver and kidney function less than 1.5 times the upper normal limit
- ECOG physical status score of 2 or less
- New York Heart Association cardiac function classification grade 2 or below
- Voluntary signed informed consent form
You will not qualify if you...
- Uncontrollable serious diseases of major organs such as extensive tumor metastasis, liver failure, heart failure, kidney failure
- Poor compliance
- Positive serology for HIV, hepatitis B, C, D viruses, syphilis, Epstein-Barr Virus DNA, or Cytomegalovirus DNA
- Extensive and severe bleeding (e.g., hemoptysis, gastrointestinal bleeding, intracranial hemorrhage)
- Current heart disease requiring treatment or poorly controlled hypertension
- Thrombotic diseases such as pulmonary embolism, thrombosis, or atherosclerosis
- History of allogeneic stem cell or organ transplantation
- Mental disorders preventing informed consent or follow-up
- Ongoing toxic symptoms from prior treatments
- Serious diseases limiting trial participation (e.g., diabetes, severe heart failure, unstable arrhythmia, unstable angina, gastric ulcers, autoimmune diseases)
- Sepsis or irregular bleeding
- Concurrent use of antiplatelet drugs
- Pregnant, suspected pregnancy, or breastfeeding
- Pre-existing cardiac disease including NYHA Grade III/IV heart failure, arrhythmia requiring treatment, recent myocardial infarction, or QT abnormalities
- Investigator's judgment that participation is not suitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive weekly subcutaneous injections of Romiplostim N01 with dose adjustments based on platelet counts to treat chemotherapy-induced thrombocytopenia.
Weekly visits for up to 24 weeks
Duration - 4 weeks
Participants have safety visits once a week for 4 weeks after ending or withdrawing from treatment to monitor adverse events.
Weekly visits for 4 weeks
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, Tianjin Municipality, China, 301600
Actively Recruiting
Research Team
T
Ting Sun, MD
Y
Yunfei Chen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here