Actively Recruiting
Phase II Study of Axicabtagene Ciloleucel with Radiotherapy in Relapsed/Refractory Follicular Lymphoma
Led by M.D. Anderson Cancer Center · Updated on 2026-05-06
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of a drug called axicabtagene ciloleucel combined with radiation therapy in patients with relapsed or refractory follicular lymphoma. This phase II study focuses on understanding the risk of serious side effects such as grade 3 or higher cytokine release syndrome within 30 days after the CAR T-cell infusion. Secondary goals include measuring response rates, survival outcomes, and exploring how tumor burden and immune cell profiles may affect treatment response. Participants will undergo a procedure to collect their white blood cells, which are used to create the axicabtagene ciloleucel treatment. Before receiving the CAR T-cell infusion, patients will have radiation therapy followed by conditioning chemotherapy. The treatment involves one infusion of axicabtagene ciloleucel administered through a vein. Additional medications such as cyclophosphamide, fludarabine phosphate, prednisone, diphenhydramine, and acetaminophen are also given intravenously as part of the treatment process. During the study, participants will be closely monitored for adverse events, with evaluations lasting about one year after treatment. Researchers will perform imaging scans to measure tumor lesions and collect blood samples to assess immune responses. The main focus is on tracking side effects, treatment effectiveness, and survival, while ensuring patient safety with regular health assessments throughout the study period.
CONDITIONS
Brief Title
A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 18 years of age or older
- Histologically proven follicular lymphoma (Grade 1-3A) on most recent biopsy, including history of transformed follicular lymphoma as allowed
- Disease that has relapsed or is refractory to 2 or more prior lines of systemic therapy
- ECOG performance status of 0-2
- Medically appropriate for CAR-T cell therapy with adequate organ function (e.g., CrCL ≥ 45 mL/min/m2, hemoglobin ≥ 8 g/dl)
- Serum ALT/AST levels ≤ 2.5 times upper limit of normal or ≤ 5 times if liver involved
- Baseline oxygen saturation ≥ 92% on room air
- At least one measurable lesion ≥ 1 cm on CT, MRI, or clinical exam
- Prior radiation therapy permitted if normal tissue tolerance not exceeded
- Female of child-bearing potential must have negative pregnancy test within 1 week of radiation therapy simulation
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- History of other invasive malignancy requiring active therapy within past 3 years, except non-melanomatous skin cancer
- Pregnant women of childbearing potential
- Breastfeeding women unwilling to stop before lymphodepleting chemotherapy and for 12 months after CAR-T cell infusion
- Urgent need for bridging chemotherapy or rituximab between apheresis and CAR T-cell infusion (steroids permitted)
- Additional radiation therapy that would exceed normal organ risk limits
- History of severe immediate hypersensitivity to aminoglycosides
- Uncontrolled fungal, bacterial, or viral infection requiring intravenous antimicrobials (except treated urinary tract infection or uncomplicated bacterial pharyngitis)
- Recent COVID-19 infection permitted only if medically stable for CAR-T cell therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Not specified
Participants undergo a procedure to collect white blood cells to make the CAR T-cell therapy product.
1 visit (in-person)
Duration - Not specified
Participants receive radiation therapy followed by conditioning chemotherapy and one infusion of axicabtagene ciloleucel.
Multiple visits including radiation therapy sessions, chemotherapy sessions, and 1 infusion visit
Duration - Up to 1 year
Participants are monitored for safety and response following CAR T-cell infusion for up to approximately 1 year.
Regular visits for safety and response assessments
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Susan Wu, MD
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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