Actively Recruiting
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
Led by M.D. Anderson Cancer Center · Updated on 2026-05-06
20
Participants Needed
1
Research Sites
242 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To learn about the safety of a drug called axicabtagene ciloleucel given in combination with radiation therapy to patients with relapsed/refractory FL.
CONDITIONS
Official 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; history of transformed follicular lymphoma allowed at clinician discretion
- Follicular lymphoma that has relapsed or is refractory to 2 or more prior systemic therapies
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Medically suitable for CAR-T cell therapy with adequate organ function (Creatinine clearance >/= 45 mL/min/m2, hemoglobin \u2265 8 g/dl, liver enzymes ALT/AST \u2264 2.5 x upper limit of normal or \u2264 5 x ULN if liver involved)
- Baseline oxygen saturation \u226592% on room air
- At least one measurable lesion \u22651 cm on CT, MRI, or clinical exam
- Prior radiation therapy allowed if normal tissue tolerance not exceeded
- Female participants of child-bearing potential must have a negative pregnancy test within 1 week before radiation simulation
- Ability to understand and sign informed consent
You will not qualify if you...
- History of other invasive cancers (non B-cell lymphoma) requiring treatment within past 3 years, except non-melanoma skin cancer
- Pregnant women of childbearing potential
- Breastfeeding women unwilling to stop before lymphodepleting chemotherapy and for 12 months after CAR-T infusion
- Urgent need for bridging chemotherapy or rituximab between apheresis and CAR-T infusion (steroids allowed)
- Radiation therapy that would exceed normal organ risk limits
- History of severe immediate allergic reaction to aminoglycosides
- Uncontrolled fungal, bacterial, or viral infections needing IV antibiotics, except urinary tract infection or uncomplicated bacterial pharyngitis if responding to treatment
- Recent COVID-19 infection allowed if medically stable for CAR-T therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Susan Wu, MD
CONTACT
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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