Study on Using Radiation Therapy After Partial Response to CAR-T in Relapsed or Refractory Non-Hodgkin Lymphoma

Sponsor: University of Texas Southwestern Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04601831

Provider View

This clinical trial is exploring whether adding targeted radiation therapy can improve outcomes for patients with relapsed or refractory Non-Hodgkin Lymphoma who have not fully responded to CAR-T cell therapy by day 30 after treatment.

Patient Parameters

Program Overview

The study aims to determine if using focused radiation therapy on specific areas of cancer that remain active after CAR-T cell therapy can help more patients achieve a complete response by day 90. Researchers believe that this approach could be safe and potentially double the number of patients who fully respond to treatment compared to historical data.

Description

CAR-T cell therapy has shown promise in treating relapsed or refractory Non-Hodgkin Lymphoma (NHL), but not all patients achieve a complete response by day 30 after treatment. This study is investigating whether adding targeted radiation therapy to areas of active cancer can help improve outcomes for these patients. The trial is divided into two phases: Phase I will focus on the safety of this approach, while Phase II will evaluate its effectiveness in increasing the number of patients who achieve a complete response by day 90. The study is based on the idea that radiation therapy can enhance the effects of CAR-T cells, potentially leading to better control of the cancer.

Eligibility Criteria

Inclusion Criteria

  • Age 18 years or older.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Diagnosed with high-grade Non-Hodgkin Lymphoma, such as Diffuse Large B-Cell Lymphoma or Primary Mediastinal B-Cell Lymphoma.
  • Previously treated with CD19-directed CAR-T cell therapy.
  • Partial response to CAR-T therapy by day 30, as shown by PET/CT scan.
  • Ability to understand and sign informed consent.
  • Agree to use effective contraception during the study and for 90 days after treatment.

Exclusion Criteria

  • Received high-dose radiation therapy to the same areas of cancer within the past year.
  • Cancer involvement in the brain or central nervous system.
  • Severe side effects from CAR-T therapy, such as high-grade cytokine release syndrome or neurotoxicity.
  • History of autoimmune disease or other conditions that prevent radiation therapy.
  • Life expectancy of less than 3 months.
  • Mental health or social issues that could interfere with study participation.
  • Pregnant or nursing women due to potential risks to the baby.
  • Uncontrolled health conditions, such as active infections, heart failure, or unstable heart conditions.

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