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.

Study Overview

• Status: Unknown
• Conditions: Relapsed DLBCL and PT/NKCLs
• Intervention / Treatment: Drug: Mitoxantrone HCL Liposome Injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Cancer Hospital
    • Contact: Mi Jiang, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mitoxantrone HCL Liposome Injection; Each treatment cycle lasts for 28 days with 20mg/m2	Drug: Mitoxantrone HCL Liposome Injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Investigators: Principal Investigator: Jun Zhu, Ph.D, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (ANTICIPATED): September 1, 2018
• Study Completion (ANTICIPATED): October 1, 2018

Study Registration Dates

• First Submitted: November 3, 2015
• First Submitted That Met QC Criteria: November 4, 2015
• First Posted (ESTIMATE): November 5, 2015

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 15, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Mitoxantrone
• Other Study ID Numbers: CSPC-HE153/PRO/Ⅱ