Status:
TERMINATED
Clinical Study of Liposomal Mitoxantrone Hydrochloride Injection Combined With Pegaspargase in the Treatment of NKTCL
Lead Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions:
Extranodal NK/T-cell Lymphoma, Nasal Type
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
This is a multicentre, open-label, single-arm, phase I/II clinical study with a dose-escalation stage (part 1) and a dose-expansion stage (part 2). In part 1, patients with treatment-naïve, relapsed/r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2022
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04509466
Start Date
September 15 2020
End Date
January 30 2022
Last Update
March 7 2024
Active Locations (1)
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1
the Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550000