This phase II trial tests the safety and how well radiotherapy followed by chemotherapy with cyclophosphamide and fludarabine and axicabtagene ciloleucel works for the treatment of patients with relapsed or refractory follicular lymphoma. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell’s DNA and may kill cancer cells. It may also lower the body’s immune response. Chemotherapy drugs, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Chimeric Antigen Receptor (CAR) T-cell Therapy, such as axicabtagene ciloleucel, is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient’s blood. Then the gene for a special receptor that binds to a certain protein on the patient’s cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving radiation followed by chemotherapy and axicabtagene ciloleucel may work better for treating patients with relapsed or refractory follicular lymphoma.
Additional locations may be listed on ClinicalTrials.gov for NCT06043323.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Susan Yao Wu
Phone: 281-630-7607
PRIMARY OBJECTIVE:
I. To determine the safety of standard of care axicabtagene ciloleucel with bridging radiotherapy (RT) in patients with relapsed or refractory follicular lymphoma, as assessed by the incidence of grade 3 or higher cytokine release syndrome (CRS) within 30 days after chimeric antigen receptor (CAR) T-cell infusion.
SECONDARY OBJECTIVES:
I. Establish the rates of CRS and immune effector cell-associated neurotoxicity syndrome (ICANS) in patients treated with CAR T-cell therapy and radiation.
II. Determine complete response rate (CR) at approximately 1 month post CAR T-cell therapy.
III. Determine complete response rate (CR) at approximately 6 months post CAR T-cell therapy.
IV. Determine the overall response rate (ORR).
V. Determine the duration of response (DOR).
VI. Determine progression free survival (PFS).
VII. Determine overall survival (OS).
EXPLORATORY OBJECTIVES:
I. Assess the impact of tumor burden as measured by metabolic tumor volume and total lesion glycolysis on positron emission tomography(PET)/computed tomography (CT) on response following CAR T-cell infusion.
II. Assess T-cell fitness from blood samples by flow cytometry and strand specific ribonucleic acid sequencing (ssRNAseq) prior to and after bridging RT.
III. Perform immune profiling of blood samples for T-cell subsets prior to and after bridging RT.
IV. Assess cytokine profile after infusion.
OUTLINE:
Patients undergo leukapheresis, followed by 2 radiation treatments. Patients receive cyclophosphamide intravenously (IV) over 60 minutes followed by fludarabine IV over 30 minutes on days -5 to -3. Patients receive axicabtagene ciloleucel IV on day 0. Patients undergo PET scan, CT scan and blood sample collection throughout the study. Patients may undergo magnetic resonance (MRI) imaging throughout the study. Patients undergo biopsy on study and may undergo biopsy during screening.
After completion of study treatment, patients are followed up at days 2, 4, 7,1 4, 30 and 3, 6, 9, 12, 18, and 24 months after CAR-T therapy.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorSusan Yao Wu
