A Study of PN20 for the Prevention of Chemotherapy-induced Thrombocytopenia in Lymphoma or Solid … (NCT06521931) | Clinical Trial Compass
CompletedPhase 1
A Study of PN20 for the Prevention of Chemotherapy-induced Thrombocytopenia in Lymphoma or Solid Tumor Patients
China24 participantsStarted 2023-12-06
Plain-language summary
The main aim of this clinical trial is to assess the safety and tolerability of PN20 in adult patients with chemotherapy-induced thrombocytopenia (CID). The main questions it aims to answer are:
* Is PN20 safe in these patients?
* Could these patients potentially benefit from PN20 prevention? Participants will
* Receive subcutaneous injections of PN20 according to weight on the first day of chemotherapy cycle, within 1 hour before the administration of chemotherapy drugs,
* Visit the clinic on Day 1 (D1), D2, D3, D4, D5, D8, D11, D13, D15 and D21 for assessment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged ≥ 18 years, regardless of gender;
. Diagnosed with lymphoma or solid tumor by pathological histology or cytology examination;
. Currently receiving a 21-day chemotherapy regimen, using one or more of the following or similar drugs: gemcitabine; platinums, including carboplatin, nedaplatin, cisplatin, lobaplatin, etc.; anthracyclines, including doxorubicin, daunorubicin, epirubicin, etc.; taxanes, including paclitaxel, docetaxel, etc.; alkylating agents, including cyclophosphamide, ifosfamide, etc.;
. The current chemotherapy regimen should be consistent with that of the previous chemotherapy cycle before enrollment, including the type and dosage of the drugs, and no medication or dosage adjustments are allowed;
. Platelet count (PLT) was between 75 and 150×10\^9/L (including the critical value) one day before the start of chemotherapy in the first treatment cycle or before enrollment;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AE in single-dose phase
Timeframe: Day 1-21 of Cycle 1 (each cycle is 21 days)
2
The proportion of patients with PLT ≥ 100×10^9/L in multiple-dose phase
Timeframe: Day 21 of Cycle 2 (each cycle is 21 days)
. There was a decrease in PLT to 25×10\^9/L≤ PLT \<75×10\^9/L during the previous chemotherapy cycle before enrollment;
. Expected survival ≥ 12 weeks;
. Eastern Cooperative Oncology Group (ECOG) Physical Score is ≤ 2;
Exclusion criteria
. With thrombocytopenia caused by non-chemotherapy within 6 months before screening, including but not limited to ethylenediaminetetraacetic acid (EDTA)-dependent pseudothrombocytopenia, hypersplenism, infection and bleeding;
. With other hematopoietic diseases other than lymphoma and chemotherapy induced thrombocytopenia, including leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome;
. The tumor has already undergone bone marrow invasion or metastasis;
. With active central nervous system metastasis (such as clinical symptoms, cerebral edema, requiring hormone intervention (excluding maintenance of low-dose hormones)), progression of brain metastasis, and carcinomatous meningitis. Subjects with previously treated brain metastases who meet the following conditions may participate in the study: clinical stability has been maintained for ≥ 2 months, and systemic hormone therapy (prednisone or other equivalent doses of hormones at a dose of \>10 mg/day) has been discontinued for \>4 weeks;
. Acute or active bleeding of clinical significance (such as gastrointestinal or central nervous system) within 7 days before screening;
. Have a history of any arteriovenous thrombosis within 6 months before screening;
. Have a history of major cardiovascular disease within 6 months before screening (such as congestive heart failure (New York Heart Association (NYHA) heart function score III-IV), arrhythmias known to increase the risk of thromboembolic events (atrial fibrillation, etc.), coronary stent implantation, angioplasty or coronary artery bypass grafting);
. Accompanying diseases that the investigator believes the investigational drug may cause unnecessary risks of, such as: severe cardiovascular and cerebrovascular diseases, digestive system diseases, liver and kidney dysfunction diseases, or a family history of mental illness;