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This is a prospective, open-label, single arm, multicenter clinical study to evaluate the safety, tolerability, efficacy in combination with tislelizumab and mitoxantrone hydrochloride liposome combination treatment in patients with relapsed or refractory Extranodal Natural Killer/T Cell Lymphoma(NKTCL)
Full description
This is a prospective, open-label, single arm, multicenter clinical study to explore the maximum tolerated dose (MTD) of liposomal mitoxantrone hydrochloride when combined with tislelizumab in patients with relapsed or refractory Extranodal Natural Killer/T Cell Lymphoma(NKTCL). Liposomal mitoxantrone hydrochloride will be given on day 1 at two different doses (16 mg/m2, 20 mg/m2) and be combined with tislelizumab. The dose limited toxicity (DLT) will be evaluated after the first cycle of therapy. A maximum of 6 cycles of therapy are planned. An dose expansion study of mitoxanquinone hydrochloride liposome at recommended phaseII dose (RP2D) dose level combined with tirelizumab was conducted to explore the efficacy and safety tolerance of the combined regimen. After 6 cycles of induction therapy, if the outcome was assessed as complete remission (CR)/partial remission (PR)/Stable disease (SD), continued maintenance therapy with tirelizumab.
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Inclusion criteria
The following required baseline laboratory data:
White blood cell,WBC≥3.0×109/L(Bone marrow invasive patient≥2.0×109/L),Absolute neutrophil count,ANC ≥1.5×109/L, (Bone marrow invasive patient≥1.0×109/L) Platelet count (PLT) ≥75×109/L, (Bone marrow invasive patient≥50×109/L) ,Hemoglobin (HB)≥ 80g/L, No granulocyte growth factor, platelet, or red blood cell transfusions were received within 14 days prior to examination.
Total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN) (The liver invasion≤3.0×ULN)Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN , Serum creatinine ,Scr ≤1.5×ULN(The liver invasion≤5.0×ULN)
Renal function:creatinine, Cr≤1.5×ULN
Coagulation function: International Normalized Ratio,INR≤1.5 ×ULN; Prothrombin Time (PT)、Activated Partial Thromboplastin Time (APTT)≤1.5×ULN(Unless the patient is receiving anticoagulant therapy and PT and APTT are within the expected range of anticoagulant therapy at screening time);
Thyroid stimulating hormone (TSH) or free thyroid hormone (FT4) or free triiodothyronine (FT3) were within 10% of normal value (note: abnormal TSH caused by non-autoimmune causes can be included in the group);
Exclusion criteria
Heart function and disease meet one of the following conditions:
Long QTc syndrome or QTc interval > 480 MS;
Complete left bundle branch block, grade II or III atrioventricular block;
Serious and uncontrolled arrhythmias requiring drug treatment;
New York Heart Association grade ≥ III;
Cardiac ejection fraction (LVEF)< 50%;
A history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities within 6 months before recruitment.、
Primary purpose
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46 participants in 1 patient group
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Central trial contact
Huiqiang Huang; Qingqing Cai
Data sourced from clinicaltrials.gov
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