A Multicenter Randomized Controlled Study on the Treatment of Refractory CTIT With Romiplostim N01 Compared to Recombinant Human Thrombopoietin

A Multicenter Randomized Controlled Study on the Treatment of Refractory CTIT With Romiplostim N01 Compared to Recombinant Human Thrombopoietin

Study Overview

• Status: Not yet recruiting
• Conditions: CTIT-Chemotherapy Induced Thrombocytopenia
• Intervention / Treatment: Drug: Romiplostim N01; Drug: Recombinant Human Thrombopoietin

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Sign a written informed consent form before enrollment;
2. Age range from 18 to 75 years old;
3. Solid tumors or hematological tumors confirmed by tissue or pathology;
4. CTIT patients caused by anti-tumor therapy;
5. At least 2 weeks of treatment with two types of platelet growth factors and no response (including rhTPO or TPO-RA)
6. Have not received treatment with Roptistine/Roptistine N01;
7. ECOG PS score: 0-2;
8. Platelet value<30 × 109/L;
9. Estimated survival time during screening is ≥ 12 weeks;
10. Subjects of childbearing age agree to take reliable contraceptive measures (including male or female condoms, contraceptive foam, contraceptive gel, contraceptive film, contraceptive cream, contraceptive suppository, abstinence and the placement of intrauterine devices, etc.) throughout the study period; Excluding female participants who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation, or more than 1 year after menopause, as well as male participants who have undergone bilateral salpingectomy or ligation;
11. Voluntarily participate in this study, sign an informed consent form, and have good compliance.

Exclusion Criteria:

-

Patients with any of the following conditions are not eligible for inclusion in this study:

1. Suffering from hematopoietic system diseases other than thrombocytopenia (CIT) caused by tumor chemotherapy drugs, including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome;
2. Screening for thrombocytopenia caused by causes other than CIT within the first 6 months, including but not limited to chronic liver disease, splenic hyperfunction, infection, and bleeding;
3. Bone marrow invasion or metastasis;
4. Have received pelvic and spinal radiation therapy, as well as bone field radiation therapy, or are currently/expected to receive radiation therapy within the three months prior to screening;
5. Screening for a history of severe cardiovascular disease within the first 6 months, such as congestive heart failure (NYHA heart function score III-IV), known arrhythmias that increase the risk of thromboembolism, such as atrial fibrillation, after coronary stent implantation, angioplasty, and coronary artery bypass grafting;
6. Any history of arterial or venous thrombosis occurring within the first 6 months of screening;
7. Screening for clinical manifestations of severe bleeding within the first two weeks, such as gastrointestinal or central nervous system bleeding;
8. Brain tumors or brain metastases;
9. Urgent treatment is required, such as vena cava syndrome and spinal cord compression syndrome;
10. Neutrophil absolute value < 1.0 × 109/L, hemoglobin < 80g/L, allowing the use of granulocyte colony-stimulating factors and red blood cells that comply with clinical norms EPO infusion therapy;
11. Significant abnormalities in liver function: patients without liver metastasis, ALT/AST>3ULN (upper limit of normal value), TBIL>3ULN； Patients with liver metastasis are present, ALT/AST≥5ULN，TBIL≥5ULN；
12. Renal dysfunction: blood creatinine ≥ 1.5ULN or eGFR ≤ 60 ml/min (Cockcroft Gault formula);
13. Within the first month prior to screening, patients who have received treatment with loperstine/loperstine N01 or recombinant human thrombopoietin (rhTPO);
14. Received platelet transfusion within the first 3 days of randomization;
15. Patients who are known or expected to be allergic or intolerant to Roxetine N01 or rhTPO excipients
16. HIV infected individuals;
17. Pregnant or lactating women;
18. Participated in any clinical study of any other investigational drug or device three months prior to screening;
19. The researchers believe that participating in the trial poses a significant risk to the health or safety of the subjects, or other circumstances that may affect the efficacy evaluation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Romiplostim N01	Drug: Romiplostim N01; 2.0 µg/kg, subcutaneous injection, once a week, up to a maximum of 8 weeks. Stop medication when platelet count increases by 50 × 109/L or more compared to before medication
Active Comparator: Recombinant Human Thrombopoietin	Drug: Recombinant Human Thrombopoietin; 30000 U/d, subcutaneously injected once a day, for a maximum of 8 weeks. Medication should be stopped when platelets increase by 50 × 109/L or more compared to before medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients with PLT ≥ 50 × 109/L within 4 weeks after receiving treatment	Within 4 weeks after receiving treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
The time required for PLT to recover to 50 × 109/L or above after treatment	up to 8 weeks
The proportion of patients with PLT ≥ 50 × 109/L after 2 weeks of treatment	2 weeks after receiving treatment
The proportion of patients with PLT ≥ 50 × 109/L after 12 weeks of treatment	12 weeks after receiving treatment
The lowest platelet count from receiving treatment to the end of treatment	up to 8 weeks
The proportion of patients receiving platelet transfusion	through study completion, an average of 5 months
The proportion of restoring anti-tumor treatment for at least 2 cycles without recurrence of CTIT	through study completion, an average of 5 months

Collaborators and Investigators

• Sponsor: Shandong University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: May 23, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Estimated): June 4, 2024

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Romiplostim N01，Recombinant Human Thrombopoietin，CTIT
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Cytopenia; Thrombocytopenia
• Other Study ID Numbers: QLMA-CIT-IIT-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No