Study on Axicabtagene Ciloleucel and Glofitamab as Second-Line Treatment for Patients with Large B Cell Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06213311

Provider View

This clinical trial is exploring whether a combination of two drugs, axicabtagene ciloleucel (axi-cel) and glofitamab, can help control large B cell lymphoma (LBCL) in patients whose cancer has returned or not responded to initial treatment.

Patient Parameters

Program Overview

The study aims to find out if using axicabtagene ciloleucel (axi-cel) and glofitamab together can effectively manage large B cell lymphoma (LBCL) in patients who have not responded to or have relapsed after their first treatment. Researchers are looking at how safe this combination is and how well it works in achieving a complete response, improving survival rates, and preventing the cancer from getting worse.

Description

This study is focused on patients with large B cell lymphoma (LBCL) who have not responded to or have relapsed after their first treatment. The main goals are to see if the combination of axicabtagene ciloleucel (axi-cel) and glofitamab is safe and effective in treating these patients. Researchers will measure how well the treatment works by looking at complete response rates, overall survival, and progression-free survival.

Additionally, the study will explore various aspects of the cancer and the body's response to treatment, such as analyzing tumor characteristics, genetic markers, and changes in circulating tumor DNA. The development of antibodies against axi-cel and the effect of glofitamab on T cell exhaustion will also be evaluated.

Participants will need to meet specific health criteria and agree to follow the study procedures, including hospital stays and regular health checks. The study will also involve genetic and blood tests to monitor the treatment's impact.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with large B cell lymphoma (LBCL) that is CD19 and CD20 positive, including cases that have transformed from less aggressive lymphomas.
  • Cancer must have returned or not responded within 12 months after the first treatment.
  • Must have received initial treatment with an anti-CD20 antibody and chemotherapy containing an anthracycline.
  • Age 18 or older.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Willing to stay in the hospital for the first dose of glofitamab.
  • Adequate blood cell counts and organ function, including kidney, liver, lung, and heart health.
  • No signs of cancer in the central nervous system.
  • Willing to use effective birth control during and after the study.
  • Able to understand and sign a consent form.
  • Certain autoimmune conditions may be allowed if well-controlled.

Exclusion Criteria

  • Previous treatment with CAR T-cell therapy or glofitamab.
  • Severe allergic reactions to certain antibiotics.
  • Uncontrolled infections or recent hospitalization for infections.
  • Uncontrolled HIV or active hepatitis B or C infections.
  • Presence of certain medical devices or drains.
  • Cancer in the brain or central nervous system.
  • Significant heart disease or recent heart attack.
  • Need for urgent treatment due to tumor effects.
  • History of certain autoimmune diseases.
  • Recent blood clots in veins or lungs.
  • Medical conditions that could interfere with the study.
  • Recent live vaccine or investigational drug use.
  • Women who are pregnant or breastfeeding.
  • Not willing to use birth control during the study.
  • Unable to complete study visits or procedures.
  • History of certain viral infections or organ transplants.

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