A Phase 2 interventional study of GVM±R regimen in Peripheral T Cell Lymphoma and Diffuse Large B-cell Lymphoma, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Phase 2, Interventional, and Treatment
This is a prospective clinical study to evaluate the safety and efficacy of GVM±R in patients with relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL).
This is a single-arm, open label, multi-center clinical study to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome in combination with gemcitabine, vinorelbine and/or anti-CD20 monoclonal antibody(GVM ± R) in patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL).Mitoxantrone hydrochloride liposome will be given on day 1 at dose of 18 mg/m2 and be combined with gemcitabine, vinorelbine and/or rituximab (Pts with CD20-positive lymphomas are evaluated by the investigator on whether to combine rituximab or choose another CD20 monoclonal antibody).Each cycle consists of 21 days. A maximum of 6 cycles of therapy are planned.
Exclusion Criteria:
The subject had previously received any of the following anti-tumor treatments:
Heart function and disease meet one of the following conditions:
Patients with relapsed or refractory aggressive NHL will undergo GVM±R therapy
Drug: GVM±R regimen
Mitoxantrone hydrochloride liposome (18 mg/m\^2) on day 1; Gemcitabine (800 mg/m\^2) on day 1,8; Vinorelbine (20mg/m\^2) on day 1,8; Rituximab (375mg/m\^2) on day 1; The regimen will be administered every 3 weeks, for a maximum of 6 cycles. The choice of CD20 monoclonal antibody will be determined by the attending physician.
Overall Response Rate (ORR)
Response is assessed according to the lugano criteria
Time frame: up to 2 years
Complete Response Rate (CRR)
Response is assessed according to the lugano criteria
Time frame: up to 2 years
Progression-Free-Survival (PFS)
From the date of the first dose of therapy is given until disease progression, death or last follow-up
Time frame: up to 2 years
Overall survival (OS)
From the date of inclusion to date of death, irrespective of cause
Time frame: up to 2 years
Incidence of Treatment-Emergent Adverse Events
The adverse events were evaluated by NCI-CTCAE 5.0 standard Hematologic and non-hematologic toxicity
Time frame: up to 2 years
Plan to share: No
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Institute of Hematology & Blood Diseases Hospital, China