Overview

Clinical Study of Liposomal Mitoxantrone Hydrochloride Injection Combined With Pegaspargase in the Treatment of NKTCL

Status:
Not yet recruiting
Trial end date:
2022-06-15
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Treatments:
Asparaginase
Mitoxantrone
Pegaspargase
Criteria
Inclusion Criteria:

1. Subjects fully understand and voluntarily participate in this study and sign informed
consent;

2. Age ≥18, ≤75 years, no gender limitation;

3. Histologically confirmed diagnosis of treatment-naïve, relapsed or refractory
extranodal NK/T-cell lymphoma nasal type (NKTCL);

4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1

5. At least one measurable lesion as per Lugano 2014 criteria;

6. Adequate bone marrow, liver, renal and coagulation function

Exclusion Criteria:

1. Known central nervous system involvement caused by lymphoma;

2. Known infiltration of the bone marrow according to criteria for leukemia (≥20%
myeloblast in the blood or bone marrow);

3. Known hemophagocytic syndrome;

4. History of allergy and contraindications to mitoxantrone hydrochloride and/or
asparaginase/ pegaspargase;

5. 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);

6. Life expectancy < 3 months

7. Impaired cardiac function or serious cardiac disease;

8. Known hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus
(HIV) or other active viral infection;

9. Acute symptomatic or chronic pancreatitis within 4 weeks prior to screening;

10. 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);

11. History of solid organ transplantation, autologous hematopoietic stem cell
transplantation within 6 months prior to screening, or allogeneic hematopoietic stem
cell transplantation before screening;

12. Major surgery within 4 weeks prior to screening. Or have a surgical schedule during
the study period;

13. A serious infection within 4 weeks prior to screening and not suitable for the study
according to the judgment of the investigator;

14. Uncontrolled diabetes at screening;

15. Known alcohol or drug abuse;

16. Known psychiatric disorders or cognitive disorder;

17. 17. Pregnant or breastfeeding women, or patients who are expecting to conceive or
father in 12 months (starting with the screening visit);

18. Not suitable for this study as determined by the investigator due to other reasons.