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

NCT ID: NCT02597387

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-10-31

Brief Summary

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

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.

Conditions

Relapsed DLBCL and PT/NKCLs

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mitoxantrone HCL Liposome Injection

Each treatment cycle lasts for 28 days with 20mg/m2

Group Type: EXPERIMENTAL

Mitoxantrone HCL Liposome Injection

Intervention Type: DRUG

Interventions

Mitoxantrone HCL Liposome Injection

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun Zhu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Beijing Cancer Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun Zhu, Ph.D

Role: CONTACT

zhujun@csco.org.cn

+86 13910333346

Yuqin Song, Ph.D

Role: CONTACT

Facility Contacts

Mi Jiang, Ph.D

Role: primary

Other Identifiers

CSPC-HE153/PRO/Ⅱ

Identifier Type: -

Identifier Source: org_study_id