Relapsed DLBCL and PT/NKCLs
Conditions
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.
Interventions
Sponsors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR; complete response + partial response [CR + PR]) | Up to 6 months |
Secondary
| 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 |
Countries
China
Contacts
Primary ContactJun Zhu, Ph.D
Backup ContactYuqin Song, Ph.D
Outcome results
None listed