Study Comparing Axicabtagene Ciloleucel with Standard Therapy for First-time Treatment in High-risk Large B-cell Lymphoma

Sponsor: Kite, A Gilead Company

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05605899

Provider View

This clinical trial is comparing a new treatment, axicabtagene ciloleucel, with the usual care for patients receiving their first treatment for high-risk large B-cell lymphoma.

Patient Parameters

Program Overview

The purpose of this study is to see how well a new treatment, axicabtagene ciloleucel, works compared to the standard treatment for people with high-risk large B-cell lymphoma. This is for patients who are receiving their first treatment for this type of cancer.

Description

Participants who receive axicabtagene ciloleucel will be followed for five years after starting the study. After that, they will join a separate long-term follow-up study to continue monitoring their health for a total of 15 years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with large B-cell lymphoma, including types like Diffuse Large B-cell Lymphoma (DLBCL) and High-grade B-cell Lymphoma (HGBL).
  • High-risk disease with a specific score (IPI score of 4 or 5) at diagnosis.
  • Have only received one cycle of a specific chemotherapy treatment (R-chemotherapy).
  • Have good bone marrow, kidney, liver, lung, and heart function.
  • Women who can have children must test negative for pregnancy before starting the study.

Exclusion Criteria

  • Certain types of lymphoma, such as T-cell/histiocyte-rich LBCL or Burkitt lymphoma.
  • Lymphoma affecting the brain or spinal fluid, or a history of such involvement.
  • Lymphoma affecting the heart.
  • Any previous treatment for large B-cell lymphoma other than one cycle of R-chemotherapy.
  • Severe allergic reactions to study drugs.
  • Brain disorders or recent history of stroke or similar conditions.
  • Active hepatitis B or C infection.
  • HIV positive unless well-controlled with medication.
  • Medical conditions or side effects from previous treatments that could affect the study.
  • Significant heart disease in the past year.
  • Conditions requiring long-term immune system suppression in the past two years.

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