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

CSPC Pharmaceutical Group

Status and phase

Unknown

Phase 2

Conditions

Relapsed DLBCL and PT/NKCLs

Treatments

Drug: Mitoxantrone HCL Liposome Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT02597387

CSPC-HE153/PRO/Ⅱ

Details and patient eligibility

About

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

Full description

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.