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

C

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Mitoxantrone HCL Liposome Injection
Experimental group
Description:
Each treatment cycle lasts for 28 days with 20mg/m2
Treatment:
Drug: Mitoxantrone HCL Liposome Injection

Trial contacts and locations

1

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Central trial contact

Jun Zhu, Ph.D; Yuqin Song, Ph.D

Data sourced from clinicaltrials.gov

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