RecruitingPhase 2NCT06086197

A-RGEMOX in the Treatment of Early Relapsed/Refractory DLBCL

Prospective, Single-center, Phase II Clinical Study of Anlotinib in Combination With Rituximab,Gemcitabine and Oxaliplatin (A-RGEMOX) in the Treatment of Early Relapsed/Refractory Diffuse Large B-cell Lymphoma


Sponsor

Zhejiang Cancer Hospital

Enrollment

41 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

As the most common subtype of lymphoma, diffuse large B-cell lymphoma (DLBCL) is an aggressive but potentially curable malignancy. However, patients with early relapse (relapse within 12 months since diagnosis or the end of first-line treatment, ER) or primary refractory had an even worse prognosis. Thus, the investigators plan to evaluate the efficacy and safety of anlotinib combined with rituximab, gemcitabine, oxaliplatin (A-RGEMOX) in the treatment of early relapsed/refractory diffuse large B-cell lymphoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination of drugs — including an anti-CD19 antibody, rituximab, gemcitabine, oxaliplatin, and methotrexate (called A-RGEMOX) — for people with a type of aggressive blood cancer called diffuse large B-cell lymphoma (DLBCL) that came back or did not respond within 12 months of first treatment. **You may be eligible if...** - You are 18 or older - You have been diagnosed with DLBCL or a related high-grade B-cell lymphoma, confirmed by tissue biopsy - Your cancer either relapsed within 12 months of completing first-line treatment or did not respond to first-line therapy - You have at least one measurable tumor on imaging - You have not had CAR-T cell therapy previously **You may NOT be eligible if...** - Your cancer has spread to the brain or spinal fluid - You have serious heart, liver, or kidney problems - You have an active serious infection - You are pregnant or breastfeeding - You have had prior CAR-T therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnlotinib hydrochloride, Rituximab, gemcitabine, oxaliplatin

Anlotinib: 12mg d1\~14 po qd, Rituximab: 375mg/m2 d1, gemcitabine: 1000mg/m2 d1 and d8, oxaliplatin: 130mg/m2 d1; For subjects ≥75 years of age, appropriate reduction of chemotherapy drugs (not less than 75% of the standard dose, or withdrawal of day 8 gemcitabine) may be decided by the investigator.


Locations(1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

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NCT06086197


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