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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

To learn about the safety of a drug called axicabtagene ciloleucel given in combination with radiation therapy to patients with relapsed/refractory FL.

Eligibility criteria

Qualifiers

Men and women 18 years of age or older

Histologically proven FL (Grade 1-3A) on most recent biopsy, history of transformed follicular lymphoma permitted at clinician discretion)

Patients with follicular lymphoma must have disease that has relapsed or is refractory to 2 or more prior lines of systemic therapy

(ECOG) performance status of 0-2

Disqualifiers

History of other (non B-cell lymphoma) invasive malignancy requiring active therapy (systemic therapy, radiation, or surgery) within the past 3 years, excluding non-melanomatous skin cancer

Women of childbearing potential who are pregnant

Women who are breastfeeding and unwilling to discontinue prior to lymphodepleting chemotherapy and for 12 months following lymphodepleting chemotherapy and CAR-T cell infusion

Urgent need for bridging chemotherapy or rituximab between apheresis and CAR T cell product infusion (steroids permitted)

Trial design

Treatments tested in this trial

  • Axicabtagene Ciloleucel
  • Cyclophosphamide
  • Fludarabine phosphate
  • Prednisone
  • Diphenhydramine
  • Acetaminophen

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators