A Study on the Treatment of CTIT of the Efficacy and Safety With Romiplostim N01 Compared to Recombinant Human Interleukin-11

NCT06759636 | Recruiting Phase 3

• 1 other identifier: QLMA-CTIT-IIT-101
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

FRIENDS-01：A Multicenter Open-label Randomized Controlled Study on the Treatment of CTIT of the Efficacy and Safety With Romiplostim N01 Compared to Recombinant Human Interleukin-11

Conditions

CTIT: Cancer Therapy Induced Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• The median number of days when the platelet count reaches 100×10^9/L or the absolute platelet count increases by 50×10^9/L

  through study completion, an average of 5 months

Secondary Outcomes (14)

• The median number of days for patients with baseline PLT counts less than 50×10^9/L and less than 75×10^9/L to achieve a PLT count of 100×10^9/L

  through study completion, an average of 5 months

• The median number of days in which thrombocytopenia increases from Grade 3 or 4 to Grade 1 or 2

  through study completion, an average of 5 months

• The average number of days when the platelet count reaches 100×10^9/L or the absolute platelet count increases by 50×10^9/L

  through study completion, an average of 5 months

• Proportion of patients with PLT reaching 100×10^9/L or absolute platelet count increase of 50×10^9/L after 1 week of treatment

  Within 1 weeks after receiving treatment

• Proportion of patients with PLT reaching 100×10^9/L or absolute platelet count increase of 50×10^9/L after 2 weeks of treatment

  Within 2 weeks after receiving treatment

Study Arms (2)

Romiplostim N01

EXPERIMENTAL

3.0 µg/kg, subcutaneous injection, once a week. Afterwards, refer to the platelet count evaluated during the visit before the next dosing cycle: ① If the platelet count is less than 50×10\^9/L, increase by 1-2μg/kg once a week; ② If the platelet count is between 50-99×10\^9/L, increase by 1μg/kg once a week. According to platelet count and symptoms, investigators can adjust the dosage to the maximum dosage of 10μg/kg once a week.

Drug: Romiplostim N01

Recombinant Human Interleukin-11

ACTIVE COMPARATOR

25-50μg/kg, subcutaneous injection, once a day

Drug: Recombinant Human Interleukin-11 (rhIL-11)

Interventions

Romiplostim N01 DRUG

3.0 µg/kg, subcutaneous injection, once a week. Afterwards, refer to the platelet count evaluated during the visit before the next dosing cycle: ① If the platelet count is less than 50×10\^9/L, increase by 1-2μg/kg once a week; ② If the platelet count is between 50-99×10\^9/L, increase by 1μg/kg once a week. According to platelet count and symptoms, investigators can adjust the dosage to the maximum dosage of 10μg/kg once a week.

Romiplostim N01

Recombinant Human Interleukin-11 (rhIL-11) DRUG

25-50μg/kg, subcutaneous injection, once a day

Recombinant Human Interleukin-11

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Voluntarily participate in this study, sign an informed consent form, and strictly complied with the study protocol requirements；
• Age range from 18 to 75 years old，male or female；
• Diagnosed with a malignant tumor by histopathology and/or cytology and is receiving anti-tumor therapy such as chemotherapy, radiotherapy, immunology, and targeting；
• ECOG PS score: 0-2；
• Developed treatment-induced thrombocytopenia with platelet count between 10×10⁹/L and 75×10⁹/L; if platelet count is between 10×10⁹/L and 50×10⁹/L, one platelet test is required with a 24-hour interval; if platelet count is between 50×10⁹/L and 75×10⁹/L, two platelet tests are required.；
• Estimated survival time during screening is ≥ 12 weeks, and could be treated with current antitumor regimens for at least 1 cycle；
• 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；
• Adequate organ and bone marrow function.

You may not qualify if:

• \. Platelet values at screening or baseline were ≤10×10\^9/L；
• Participants with a history of any hematological malignancy，including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome；
• Participants had a history of chronic platelet or bleeding disorders，or 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；
• Bone marrow invasion or metastasis;
• 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;
• Brain tumors or brain metastases;
• 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;
• Any history of arterial or venous thrombosis occurring within the first 6 months of screening;
• Screening for clinical manifestations of severe bleeding within the first two weeks, such as gastrointestinal or central nervous system bleeding;
• Neutrophil absolute value \< 1.0 × 10\^9/L, hemoglobin \< 80g/L, allowing the use of granulocyte colony-stimulating factors and red blood cells that comply with clinical norms EPO infusion therapy
• 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;
• Renal dysfunction: blood creatinine ≥ 1.5ULN or eGFR ≤ 60 ml/min (Cockcroft Gault formula);
• Received thrombopoietin receptor agonists, recombinant human thrombopoietin (rhTPO), or recombinant human interleukin-11 (rhIL-11) within 5 half-lives of the drug prior to screening. The maximum washout period calculated based on 5 half-lives of the drugs is: hetrombopag 8.4 days, avatrombopag 4 days, eltrombopag 6.7 days, lusutrombopag 6 days, romiplostim or romiplostim N01 29 days, rhTPO 9.7 days, rhIL-11 1.4 days;
• Received platelet transfusion within the first two weeks of randomization;
• Participants who are known or expected to be allergic or intolerant to Roxetine N01 or rhIL-11 excipients;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Interventions

Interleukin-11; oprelvekin

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Central Study Contacts

Xiaofeng Chen Xiaofeng Chen, Chief physician

CONTACT

86+13585172066; xiaofengch198019@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 6, 2025
• Study Start: February 24, 2025
• Primary Completion: April 21, 2026
• Study Completion: July 21, 2026
• Last Updated: April 14, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)