RecruitingPhase 2NCT06244368

GVM±R in Patients With Relapsed or Refractory Aggressive NHL.

A Single Arm, Open Label, Multi-center Study of Mitoxantrone Hydrochloride Liposome, Gemcitabine, Vinorelbine With or Without Anti-CD20 Monoclonal Antibody (GVM±R) in Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

115 participants

Start Date

Jan 17, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a chemotherapy combination called GVM (gemcitabine, vinorelbine, and pegylated liposomal doxorubicin), with or without rituximab (an antibody targeting CD20), in people with aggressive non-Hodgkin lymphoma (NHL) that has come back after previous treatment or did not respond to prior therapy. **You may be eligible if...** - You are between 18 and 65 years old - You have aggressive non-Hodgkin lymphoma that has relapsed (came back after a response lasting more than 6 months) or is refractory (never responded, or responded for less than 6 months) - You have already received at least one prior standard treatment - Your expected survival is at least 3 months - Your liver, kidneys, and blood counts meet the minimum requirements **You may NOT be eligible if...** - You have active brain lymphoma involvement - You have had a prior stem cell transplant using donor cells (allogeneic transplant) - You have serious uncontrolled infections or active hepatitis B or C - You have a severe autoimmune condition requiring long-term steroids - You have a serious heart condition including uncontrolled arrhythmia or heart failure 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

DRUGGVM±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.


Locations(1)

Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC

Tianjin, Tianjin Municipality, China

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NCT06244368


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