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

ConditionFollicular 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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Axicabtagene Ciloleucel
Drug
Given by IV (vein)
Cyclophosphamide
Drug
Given by IV (vein)
Fludarabine phosphate
Drug
Given by IV (vein)
Prednisone
Drug
Given by IV (vein)
Diphenhydramine
Drug
Given by IV (vein)
Acetaminophen
Drug
Given by IV (vein)

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Axicabtagene CiloleuceExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame

through study completion; an average of 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov

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