Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06086197

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

Led by Zhejiang Cancer Hospital · Updated on 2024-06-25

41

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older with an ECOG score of 2 or less
  • Histopathologically confirmed diffuse large B-cell lymphoma or related high-grade B-cell lymphoma
  • Early relapse (disease progression within 12 months after first-line treatment) or refractory disease with no response to the most recent systemic treatment
  • At least one evaluable or measurable lesion according to Lugano2014 criteria
  • Adequate organ and bone marrow function with specified blood counts and liver, kidney, and coagulation parameters
  • Left ventricular ejection fraction of 50% or higher
  • Negative pregnancy test and effective contraception use during study and for 6 months after last chemotherapy
  • Life expectancy greater than 3 months
  • Voluntary participation with informed consent and ability to complete all test procedures
Not Eligible

You will not qualify if you...

  • Primary central nervous system diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma
  • Hemophagocytic syndrome at diagnosis
  • Central nervous system involvement secondary to lymphoma
  • Participation in other clinical studies or recent administration of study drugs within 4 weeks
  • Active malignancy within 2 years except for certain treated cancers
  • History of HIV infection or AIDS
  • Positive hepatitis B surface antigen or hepatitis C antibody without controlled infection
  • Major surgery within 28 days prior to study start
  • Active infections requiring systemic therapy within 14 days prior to treatment
  • Severe or uncontrolled diseases including symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, or active peptic ulcer
  • History of severe bleeding disorders or spontaneous bleeding requiring intervention
  • Stroke or intracranial hemorrhage within 6 months prior to study drug administration
  • Deep vein thrombosis or pulmonary embolism within 12 months prior to study drug administration
  • Need for simultaneous antiplatelet and anticoagulant therapy without alternatives
  • Continuous treatment with strong CYP1A2 or CYP3A inhibitors or inducers within 7 days before study drug
  • Known hypersensitivity to study drugs
  • Deemed unsuitable for the study by researchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310022

Actively Recruiting

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Research Team

X

Xi Chen

CONTACT

H

Haiyan Yang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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