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 range18 Years – 75 Years

SexALL

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

✕. 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

What they're measuring

Part 1：dose limiting toxicities (DLTs)

Timeframe: Cycle 1 (a cycle = 21 days)

Part 2 (treatment-naïve patients):The percentage of patients who achieve complete response (CR)

Timeframe: up to 18 weeks

Part 2 (relapsed or refractory patients):The percentage of patients who achieve complete response (CR)

Timeframe: up to 26 weeks

Part 2 (relapsed or refractory patients):The percentage of patients who achieve partial response (PR)

Timeframe: up to 26 weeks

Trial details

NCT IDNCT04509466

SponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-01-30

View on ClinicalTrials.gov More Extranodal NK/T-cell Lymphoma, Nasal Type trials

Who can participate

Age range18 Years – 75 Years

SexALL

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

✕. 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

What they're measuring

Part 1：dose limiting toxicities (DLTs)

Timeframe: Cycle 1 (a cycle = 21 days)

Part 2 (treatment-naïve patients):The percentage of patients who achieve complete response (CR)

Timeframe: up to 18 weeks

Part 2 (relapsed or refractory patients):The percentage of patients who achieve complete response (CR)

Timeframe: up to 26 weeks

Part 2 (relapsed or refractory patients):The percentage of patients who achieve partial response (PR)

Timeframe: up to 26 weeks