Phase II Study of Axicabtagene Ciloleucel (CAR T-Cell Therapy) with Radiation for Treating Relapsed or Hard-to-Treat Follicular Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06043323

Provider View

This clinical trial is exploring the safety of combining a CAR T-cell therapy called axicabtagene ciloleucel with radiation therapy for patients whose follicular lymphoma has returned or is not responding to treatment.

Patient Parameters

Program Overview

The study aims to find out if using axicabtagene ciloleucel, a type of CAR T-cell therapy, together with radiation therapy is safe for patients with follicular lymphoma that has come back or is difficult to treat. Researchers will monitor for any serious side effects, especially within 30 days after the CAR T-cell treatment.

Description

The main goal of this study is to determine if the combination of axicabtagene ciloleucel, a CAR T-cell therapy, and radiation therapy is safe for patients with relapsed or refractory follicular lymphoma. Researchers will look for any serious side effects, such as cytokine release syndrome (CRS), within 30 days after the CAR T-cell infusion.

Secondary goals include:

  • Measuring the rates of CRS and neurological side effects (ICANS) in patients receiving the treatment.
  • Determining how many patients achieve a complete response (CR) about one month after the CAR T-cell therapy.
  • Evaluating the overall response rate (ORR) and how long the response lasts (DOR).
  • Assessing progression-free survival (PFS) and overall survival (OS).

Exploratory goals involve examining how the amount of cancer in the body, as seen on PET/CT scans, affects the response to the CAR T-cell therapy.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Diagnosed with follicular lymphoma (Grade 1-3A).
  • Cancer has returned or not responded after at least two previous treatments.
  • Good general health with an ECOG performance status of 0-2.
  • Suitable for CAR T-cell therapy with adequate organ function and oxygen levels.
  • Have at least two measurable cancer lesions, with one not included in the radiation treatment.
  • Previous radiation therapy is allowed if it does not exceed safe limits.
  • Women of childbearing potential must have a negative pregnancy test before starting radiation therapy.
  • Able to understand and willing to sign a consent form.

Exclusion Criteria

  • Have transformed follicular lymphoma or Grade 3B follicular lymphoma.
  • Have had another invasive cancer needing treatment in the past 3 years, except for certain skin cancers.
  • Pregnant women or those who are breastfeeding and unwilling to stop before and after treatment.
  • Need for urgent chemotherapy or rituximab between cell collection and CAR T-cell infusion (steroids are allowed).
  • Additional radiation would exceed safe limits for organs.
  • Severe allergic reaction to aminoglycosides.
  • Uncontrolled infections needing IV treatment, except for certain minor infections.
  • Recent COVID-19 infection is allowed if stable for CAR T-cell therapy.

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