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Trial record 1 of 9 for:    Mitoxantrone HCL Liposome Injection
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Clinical Trial of Mitoxantrone HCL Liposome Injection in Patients With Relapsed DLBCL and PT/NKCLs

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ClinicalTrials.gov Identifier: NCT02597387
Recruitment Status : Recruiting
First Posted : November 5, 2015
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Relapsed DLBCL and PT/NKCLs Drug: Mitoxantrone HCL Liposome Injection Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : October 2018


Arm Intervention/treatment
Experimental: Mitoxantrone HCL Liposome Injection
Each treatment cycle lasts for 28 days with 20mg/m2
Drug: Mitoxantrone HCL Liposome Injection



Primary Outcome Measures :
  1. Objective response rate (ORR; complete response + partial response [CR + PR]) [ Time Frame: Up to 6 months ]

Secondary Outcome Measures :
  1. Duration of Response (DOR) [ Time Frame: 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) ]
  2. Time to Response (TTR) [ Time Frame: 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) ]
  3. Progression-free survival (PFS) [ Time Frame: Up to a total of 24 months after first dose or until disease progression, withdrawal from study, or death ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02597387


Contacts
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Contact: Jun Zhu, Ph.D +86 13910333346 zhujun@csco.org.cn
Contact: Yuqin Song, Ph.D

Locations
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China
Beijing Cancer Hospital Recruiting
Beijing, China
Contact: Mi Jiang, Ph.D         
Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
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Principal Investigator: Jun Zhu, Ph.D Beijing Cancer Hospital

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Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT02597387     History of Changes
Other Study ID Numbers: CSPC-HE153/PRO/Ⅱ
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
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Mitoxantrone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action