Clinical Trial of Mitoxantrone HCL Liposome Injection in Patients With Relapsed DLBCL and PT/NKCLs

A Single-arm, Open, Multi-center Phase II Clinical Trial of Mitoxantrone HCL Liposome Injection in Subjects With Relapsed Diffuse Large B-cell Lymphoma and and Peripheral T/NK Lymphomas

To study efficacy and safety of Mitoxantrone HCL Liposome Injection in patients with diffuse large B-cell lymphoma and lymphoma peripheral T cell.

A Single-arm, Open, Multi-center Phase II Clinical Trial of Mitoxantrone HCL Liposome Injection in Subjects With Relapsed Diffuse Large B-cell Lymphoma and and Peripheral T/NK Lymphomas with dose of 20 mg/m2.

Inclusion Criteria:

• The subjects are voluntary and sign the informed consent form;

• ECOG score 0 to 2;

• The expected survival time ≥3 months;

• Diffuse large B-cell and peripheral T/NK cell non-Hodgkin's lymphomas confirmed with histopathology, and the peripheral T/NK cell lymphomas that are only limited to the following types: peripheral T-cell lymphoma (not otherwise specified), angioimmunobl;

• Failure or relapse after at least once of systemic treatment, and patients who can not receive autologous peripheral blood stem cell transplantation

• The major diameter of a single measurable lesion ≥1.5 cm in at least one measurable lesion;

• An interval of at least four weeks after the target tumor was treated with chemotherapy, radiotherapy, biological therapy, stem cell transplantation or other study drugs;

• Subjects at childbearing age agree to take effective contraceptive measures during the study; blood pregnancy test result is negative (except infertility due to menopause or operation);

• Laboratory tests (blood routine, liver and kidney function) meet the following requirements:

  • ANC≥ 1.5×109/L, for those with bone marrow involvement, ANC ≥ 1.0×109/L;
  • PLT ≥ 75×109/L, for those with bone marrow involvement, PLT ≥ 50 × 109/L;
  • Hb ≥ 9 g/dL; d) Cr) ≤ 1.5x ULN ;
  • TBIL ≤ 1.5x ULN;
  • AST or ALT ≤2.5 x ULN (for patients with liver metastases, ≤ 5 x ULN ).

Exclusion Criteria:

• Pregnant or lactating women;
• An allergic history to anthracyclines or liposome drugs;
• Disease progression or recurrence after anthracycline treatment within six months before the enrollment;"
• Patients who once used mitoxantrone injection;
• Patients who have used doxorubicin (or pirarubicin) with the total cumulative dose> 360mg/m2, or epirubicin with the total cumulative dose > 600mg/m2;
• Left ventricular ejection fraction is < 50% or < the lower limit of normal; clinically significant QT interval prolongation (>450ms in male, >470ms in female); a past history of cardiac disease caused by anthracyclines; a history of severe heart disease;
• Concomitant treatment as other anticancer drugs are needed;
• Lymphoma involving the central nervous system;
• Clinically active infection that can significantly affect the clinical trial;
• Within 6 weeks after organ transplantation or major organ surgery;
• Those who are inappropriate to be enrolled as evaluated by the researchers.