Clinical trial
A Multicentre, Open-label, Single-arm, Phase I/II Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of Liposomal Mitoxantrone Hydrochloride Injection Combined With Pegaspargase in the Treatment of NKTCL
Name
HE071-CSP-012
Description
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).
Trial arms
Trial start
2020-09-15
Estimated PCD
2022-01-30
Trial end
2022-01-30
Status
Terminated
Phase
Early phase I
Treatment
Part 1: Liposomal mitoxantrone hydrochloride and Pegaspargase
Drug: Liposomal mitoxantrone hydrochloride (12mg/m2, 16mg/m2, 20mg/m2, 24mg/m2) is administered by an intravenous infusion (IV) on day 1 of each 21-day cycle.
Drug: Pegaspargase (2000IU/m2) is administered by an intramuscular injection (IM) on day 1 of each 21-day cycle.
Arms:
dose escalation (part 1)
Other names:
Part 1
Part 2 (treatment-naïve patients): Liposomal mitoxantrone hydrochloride and Pegaspargase
Drug: Liposomal mitoxantrone hydrochloride (RP2D defined in Part 1) is administered by an intravenous infusion (IV) on day 1 of each 21-day cycle.
Drug: Pegaspargase (2000IU/m2) is administered by an intramuscular injection (IM) on day 1 of each 21-day cycle.
Arms:
dose escalation (part 1)
Other names:
Part 2 (treatment-naïve patients)
Part 2 (relapsed or refractory patients): Liposomal mitoxantrone hydrochloride and Pegaspargase
Drug: Liposomal mitoxantrone hydrochloride (RP2D defined in Part 1) is administered by an intravenous infusion (IV) on day 1 of each 21-day cycle.
Drug: Pegaspargase (2000IU/m2) is administered by an intramuscular injection (IM) on day 1 of each 21-day cycle.
Arms:
dose escalation (part 1)
Other names:
Part 2 (relapsed or refractory patients)
Size
41
Primary endpoint
Part 1:dose limiting toxicities (DLTs)
Cycle 1 (a cycle = 21 days)
Part 2 (treatment-naïve patients):The percentage of patients who achieve complete response (CR)
up to 18 weeks
Part 2 (relapsed or refractory patients):The percentage of patients who achieve complete response (CR)
up to 26 weeks
Part 2 (relapsed or refractory patients):The percentage of patients who achieve partial response (PR)
up to 26 weeks
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 41, 'type': 'ACTUAL'}}
Updated at
2024-03-07
1 organization
3 products
2 indications
Organization
CSPC ZhongQi Pharmaceutical TechnologyProduct
Liposomal mitoxantroneIndication
Extranodal NK/T-cell LymphomaIndication
Nasal TypeProduct
Liposomal Mitoxantrone