Not Yet RecruitingPhase 3

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

60 participantsStarted 2024-06-01

Plain-language summary

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Sign a written informed consent form before enrollment;
✓. Age range from 18 to 75 years old;
✓. Solid tumors or hematological tumors confirmed by tissue or pathology;
✓. CTIT patients caused by anti-tumor therapy;
✓. At least 2 weeks of treatment with two types of platelet growth factors and no response (including rhTPO or TPO-RA)
✓. Have not received treatment with Roptistine/Roptistine N01;
✓. ECOG PS score: 0-2;
✓. Platelet value\<30 × 109/L;

✕. 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;
✕. 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;
✕. 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;
✕. Brain tumors or brain metastases;

The proportion of patients with PLT ≥ 50 × 109/L within 4 weeks after receiving treatment

Timeframe: Within 4 weeks after receiving treatment

NCT IDNCT06440824

SponsorShandong University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-01

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Sign a written informed consent form before enrollment;
✓. Age range from 18 to 75 years old;
✓. Solid tumors or hematological tumors confirmed by tissue or pathology;
✓. CTIT patients caused by anti-tumor therapy;
✓. At least 2 weeks of treatment with two types of platelet growth factors and no response (including rhTPO or TPO-RA)
✓. Have not received treatment with Roptistine/Roptistine N01;
✓. ECOG PS score: 0-2;
✓. Platelet value\<30 × 109/L;

✕. 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;
✕. 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;
✕. 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;
✕. Brain tumors or brain metastases;