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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Relapsed DLBCL and PT/NKCLs

Intervention / Treatment
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* Drug: Mitoxantrone HCL Liposome Injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mitoxantrone HCL Liposome Injection<br>Each treatment cycle lasts for 28 days with 20mg/m2 | Drug: Mitoxantrone HCL Liposome Injection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR; complete response + partial response [CR + PR]) |  | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Response (DOR) |  | Time from the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression is documented (assessed up to approximately 24 months) | 
| Time to Response (TTR) |  | Time from the date of registration to the date at which the patient's objective status is first noted to be a CR or PR (assessed up to approximately 24 months) | 
| Progression-free survival (PFS) |  | Up to a total of 24 months after first dose or until disease progression, withdrawal from study, or death |