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CAR T-cell Therapy

CAR T-Cell Therapy + Radiotherapy for Follicular Lymphoma

Phase 2

Recruiting

Led By Susan Wu, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have at least 2 measurable lesions on imaging, defined as lesions 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. At least one lesion will be omitted from the radiation treatment field.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine if it is safe to give a drug called axicabtagene ciloleucel along with radiation therapy to patients with relapsed or refractory FL.

Who is the study for?

This trial is for adults over 18 with Follicular Lymphoma that's come back or hasn't responded after at least two treatments. They should be fairly active (able to care for themselves), have good organ function, and no severe liver issues. Participants need measurable cancer lesions, can have had past radiation if safe, and women able to have children must test negative for pregnancy.

What is being tested?

The study tests axicabtagene ciloleucel (a CAR-T cell therapy) combined with radiotherapy in patients with relapsed/refractory Follicular Lymphoma. It aims to assess the safety of this combination treatment.

What are the potential side effects?

Potential side effects include immune system reactions, infusion-related symptoms like fever or chills, low blood counts leading to increased infection risk or bleeding problems, fatigue, and possible damage to organs from the radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have at least 2 tumors that can be measured and are larger than 1 cm.

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My organs are functioning well enough for CAR-T cell therapy.

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My cancer is follicular lymphoma grades 1 to 3A.

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My condition did not improve after 2 or more treatments.

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I can take care of myself and am up and about more than half of the day.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Axicabtagene CiloleuceExperimental Treatment6 Interventions

Participants will first have a procedure to collect your white blood cells that will be used to make axicabtagene ciloleucel. Then participatns will receive radiation therapy, followed by conditioning chemotherapy and 1 infusion of axicabtagene ciloleucel.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Axicabtagene Ciloleucel

2020

Completed Phase 2

~510

Prednisone

2014

Completed Phase 4

~2500