Clinical trial NCT02597387: Clinical Trial of Mitoxantrone HCL Liposome Injection in Patients With Relapsed DLBCL and PT/NKCLs
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Relapsed DLBCL and PT/NKCLs
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-11-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Objective response rate (ORR; complete response + partial response [CR + PR])
timeFrame: Up to 6 months
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: 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)
measure: Time to Response (TTR)
timeFrame: 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)
measure: Progression-free survival (PFS)
timeFrame: Up to a total of 24 months after first dose or until disease progression, withdrawal from study, or death
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jun Zhu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: