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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
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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:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
50 participants in 1 patient group
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Central trial contact
Jun Zhu, Ph.D; Yuqin Song, Ph.D
Data sourced from clinicaltrials.gov
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