Romiplostim N01 for Chemotherapy-induced Thrombocytopenia

NCT ID: NCT07063225

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2026-08-31

Brief Summary

To evaluate the efficacy and safety of Romiplostim N01 to treat chemotherapy-induced thrombocytopenia in tumors

Detailed Description

The investigator had registered a clinical trial of Eltrombopag in the treatment of chemotherapy-induced thrombocytopenia（NCT04600960）. Due to the late launch of Romiplostim N01 in China, the investigator also collected the information of Romiplostim N01 in the treatment of chemotherapy-induced thrombocytopenia according to the protocal of Eltrombopag in the treatment of chemotherapy-induced thrombocytopenia（NCT04600960）.

This is a single-arm study to evaluate the safety and efficacy of Romiplostim N01 to treat chemotherapy-induced thrombocytopenia （CIT）in tumors. These subjects have been treated with recombinant human thrombopoietin（rhTPO） or interleukin 11（IL-11） before, the platelets can rise to normal or reach the effective standard, but after the re-application, the effective standard is not reached, or the effective standard is still not reached after the rhTPO 300U/kg/d treatment for 14 days. The investigator will assess the changes of the platelet counts after the treatment of Romiplostim N01 from week 1 to week 24, and observe incidence of adverse events during the treatment of Romiplostim N01. The investigator will complete the 4 weeks safety visits（once a week），if the subjects end or withdraw from the clinical trial.

Patients with chemotherapy-induced thrombocytopenia who had the same inclusion and exclusion criteria in the same period or in the past will be compared with the efficacy and safety of supportive treatment and Eltrombopag in the same period or history, so as to preliminarily explore and evaluate the efficacy and safety of Romiplostim N01 treatment.

Conditions

Chemotherapy-induced Thrombocytopenia; Romiplostim N01

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Romiplostim N01

50 enrolled subjects will be picked up to take Romiplostim N01 at the indicated dose.

Group Type: EXPERIMENTAL

Romiplostim N01

Intervention Type: DRUG

The subjects will receive ropivacaine N01 treatment, with an initial dose of (2-3) µg/kg. When the dose is less than 250 µg, 250 µg (1 vial) can be administered (subcutaneously), once a week. The dose will be increased by (1) µg/kg each week, up to a maximum of 10 µg/kg, until the platelet count reaches ≥ 50 × 10\^9/L. If the platelet count returns to normal, the dose can be reduced according to the platelet level as appropriate.

Interventions

Romiplostim N01

The subjects will receive ropivacaine N01 treatment, with an initial dose of (2-3) µg/kg. When the dose is less than 250 µg, 250 µg (1 vial) can be administered (subcutaneously), once a week. The dose will be increased by (1) µg/kg each week, up to a maximum of 10 µg/kg, until the platelet count reaches ≥ 50 × 10\^9/L. If the platelet count returns to normal, the dose can be reduced according to the platelet level as appropriate.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: collaborator

Tianjin Medical University Second Hospital

OTHER

Sponsor Role: collaborator

Tianjin Third Central Hospital

OTHER

Sponsor Role: collaborator

Tianjin People's Hospital

OTHER

Sponsor Role: collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: collaborator

The Second Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role: collaborator

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yunfei Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Science and Blood Disease Hospital

Locations

Chinese Academy of Medical Science and Blood Disease Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ting Sun, MD

Role: CONTACT

sunting@ihcams.ac.cn

+8615822339131

Yunfei Chen, MD

Role: CONTACT

henyunfei@ihcams.ac.cn

8618502220788

Facility Contacts

Ting Sun, MD

Role: primary

sunting@ihcams.ac.cn

8623608180

Lei Zhang, MD

Role: backup

zhanglei1@ihcams.ac.cn

8623608185

Other Identifiers

IIT2025061

Identifier Type: -

Identifier Source: org_study_id