Clinical Study of Liposomal Mitoxantrone Hydrochloride Injection Combined With Pegaspargase in the Treatment of NKTCL
Extranodal NK/T-cell Lymphoma, Nasal Type
About this trial
This is an interventional treatment trial for Extranodal NK/T-cell Lymphoma, Nasal Type
Eligibility Criteria
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:
- 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;
- Acute symptomatic or chronic pancreatitis within 4 weeks prior to screening;
- History of, or known additional tumor (exception: non-melanoma skin cancer (in situ) and cervical cancer (in situ) which have been cured and have not recurred within 5 years);
- History of solid organ transplantation, autologous hematopoietic stem cell transplantation within 6 months prior to screening, or allogeneic hematopoietic stem cell transplantation before screening;
- Major surgery within 4 weeks prior to screening. Or have a surgical schedule during the study period;
- A serious infection within 4 weeks prior to screening and not suitable for the study according to the judgment of the investigator;
- Uncontrolled diabetes at screening;
- Known alcohol or drug abuse;
- Known psychiatric disorders or cognitive disorder;
- 17. Pregnant or breastfeeding women, or patients who are expecting to conceive or father in 12 months (starting with the screening visit);
- Not suitable for this study as determined by the investigator due to other reasons.
Sites / Locations
Arms of the Study
Arm 1
Experimental
dose escalation (part 1)
dose escalation (part 1):Patients with treatment-naïve, relapsed or refractory extranodal natural killer/T-cell lymphoma (nasal type) will receive liposomal mitoxantrone hydrochloride plus a standard dose of pegaspargase every 21 days (a cycle) for a maximum of 6 cycles. The starting dose of liposomal mitoxantrone hydrochloride is 12mg/m2.dose expansion, treatment-naïve patients (part 2):Patients with treatment-naïve extranodal natural killer/T-cell lymphoma (nasal type) will receive liposomal mitoxantrone hydrochloride at RP2D plus a standard dose of pegaspargase every 21 days (a cycle) for a maximum of 6 cycles. dose expansion, relapsed or refractory patients (part 2):Patients with relapsed or refractor extranodal natural killer/T-cell lymphoma (nasal type) will receive liposomal mitoxantrone hydrochloride at RP2D plus a standard dose of pegaspargase every 21 days (a cycle) for a maximum of 6 cycles.