Clinical trial · Interventional
Clinical Trial of Mitoxantrone HCL Liposome Injection in Patients With Relapsed DLBCL and PT/NKCLs
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
NCT02597387CI-TRIAL-00034422unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To study efficacy and safety of Mitoxantrone HCL Liposome Injection in patients with diffuse large B-cell lymphoma and lymphoma peripheral T cell.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed DLBCL and PT/NKCLs | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mitoxantrone HCL Liposome Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Mitoxantrone HCL Liposome Injection
- description
- Each treatment cycle lasts for 28 days with 20mg/m2
- interventionNames
- Drug: Mitoxantrone HCL Liposome Injection
Primary outcomes (1)
- measure
- Objective response rate (ORR; complete response + partial response [CR + PR])
- timeFrame
- Up to 6 months
Secondary outcomes (3)
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.