A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell T… (NCT06043323) | Clinical Trial Compass
RecruitingPhase 2
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
United States20 participantsStarted 2024-01-08
Plain-language summary
To learn about the safety of a drug called axicabtagene ciloleucel given in combination with radiation therapy to patients with relapsed/refractory FL.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
Eligible subjects will be considered for inclusion if they meet all of the following criteria:
* 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
* Medically appropriate for CAR-T cell therapy: adequate organ function CrCL \>/= 45 mL/min/m2, hemoglobin level ≥ 8 g/dl, serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) levels ≤ 2.5 × upper limit of normal (ULN) or ≤ 5 x ULN if documented liver involvement, baseline oxygen saturation levels (SpO2) ≥92% on room air
* Have at least 1 measurable lesion on imaging, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) and ≥1 cm on CT, MRI, or clinical exam.
* Prior radiation therapy is permitted provided normal tissue tolerance is not exceeded
* Female of child-bearing potential (FOCBP, defined below) must have a negative pregnancy test within 1 week of simulation for RT
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* History of other (non B-cell lymphoma) invasive malignancy requiring active therapy (systemic therapy, rad…
What they're measuring
1
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Timeframe: through study completion; an average of 1 year