Clinical Study of Liposomal Mitoxantrone Hydrochloride Injection Combined With Pegaspargase in th… (NCT04509466) | Clinical Trial Compass
TerminatedPhase 1/2
Clinical Study of Liposomal Mitoxantrone Hydrochloride Injection Combined With Pegaspargase in the Treatment of NKTCL
Stopped: The sponsor has adjusted its R\&D strategy.
China41 participantsStarted 2020-09-15
Plain-language summary
This is a multicentre, open-label, single-arm, phase I/II clinical study to evaluate the safety, efficacy and pharmacokinetics of liposomal mitoxantrone hydrochloride in combination with pegaspargase in patients with extranodal natural killer/T-cell lymphoma, nasal type (NKTCL).
Who can participate
Age range
18 Years – 75 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
. Subjects fully understand and voluntarily participate in this study and sign informed consent;
. Age ≥18, ≤75 years, no gender limitation;
. Histologically confirmed diagnosis of treatment-naïve, relapsed or refractory extranodal NK/T-cell lymphoma nasal type (NKTCL);
. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
. At least one measurable lesion as per Lugano 2014 criteria;
. Adequate bone marrow, liver, renal and coagulation function
Exclusion criteria
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
Part 1：dose limiting toxicities (DLTs)
Timeframe: Cycle 1 (a cycle = 21 days)
2
Part 2 (treatment-naïve patients):The percentage of patients who achieve complete response (CR)
Timeframe: up to 18 weeks
3
Part 2 (relapsed or refractory patients):The percentage of patients who achieve complete response (CR)
Timeframe: up to 26 weeks
4
Part 2 (relapsed or refractory patients):The percentage of patients who achieve partial response (PR)
. Known central nervous system involvement caused by lymphoma;
. Known infiltration of the bone marrow according to criteria for leukemia (≥20% myeloblast in the blood or bone marrow);
. Known hemophagocytic syndrome;
. History of allergy and contraindications to mitoxantrone hydrochloride and/or asparaginase/ pegaspargase;
. Chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor treatment within 4 weeks of the first dose of the study drug (2 weeks for the local radiation therapy for pain relief);
. Life expectancy \< 3 months
. Impaired cardiac function or serious cardiac disease;
. Known hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other active viral infection;