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CAR T-cell Therapy
Axicabtagene Ciloleuce 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 through study completion; an average of 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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 ~ through study completion; an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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
Prednisone
2014
Completed Phase 4
~2370
Axicabtagene Ciloleucel
2015
Completed Phase 2
~490
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine phosphate
2007
Completed Phase 2
~360
Diphenhydramine
2002
Completed Phase 4
~1170
Acetaminophen
2017
Completed Phase 4
~2030
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,454 Total Patients Enrolled
Susan Wu, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
447 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals currently being admitted to participate in this trial?
"Indeed, the information available on clinicaltrials.gov indicates that this particular study is currently in the recruitment phase. The trial was initially posted on January 8th, 2024 and was most recently updated on the same day. It aims to enroll a total of 20 patients from a single site."
Answered by AI
What is the current number of individuals actively participating in this research endeavor?
"Indeed, the details on clinicaltrials.gov affirm that this investigation is presently seeking individuals to participate. The trial was initially posted on January 8th, 2024 and last revised on the same day. Specifically, they aim to recruit 20 participants from a single site."
Answered by AI
What are the potential risks associated with Axicabtagene Ciloleuce in terms of patient safety?
"Based on the assessment from our team at Power, the safety of Axicabtagene Ciloleuce is estimated to be 2 on a scale of 1 to 3. This rating reflects that there exists some data supporting its safety; however, no data has been collected yet regarding its efficacy for this Phase 2 trial."
Answered by AI
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