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CAR T-cell Therapy
Bridging Radiation Therapy for Lymphoma
Phase 1
Recruiting
Led By Christopher D'Angelo, MD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is studying if radiation before CAR T-cell therapy is safe & effective for B-cell lymphoma that didn't respond to treatment or got worse.
Who is the study for?
This trial is for adults aged 19 or older with B-cell lymphoma that has returned or worsened despite treatment. They should be able to perform daily activities (ECOG status 0-2) and have a type of lymphoma eligible for liso-cel infusion, with at least one tumor site safe for radiation. Participants must have good organ function and agree to the study's procedures.Check my eligibility
What is being tested?
The trial is testing if low dose radiation can be used as a 'bridge' before CAR T-cell therapy in patients with certain types of B-cell lymphoma. It aims to determine the feasibility and safety of this approach prior to administering the standard CAR T-cell treatment.See study design
What are the potential side effects?
Potential side effects may include skin irritation, fatigue, nausea, and other typical reactions associated with radiation therapy. The subsequent CAR T-cell therapy could cause immune system-related side effects such as fever, difficulty breathing, and changes in blood pressure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of the intervention in the proposed study population
Secondary outcome measures
Chimeric Antigen Receptor T-Cell Therapy
Evaluate overall survival (OS) following study intervention
Evaluate progression-free survival (PFS) following the study intervention
+5 moreOther outcome measures
Disease
Serum
Gastrointestinal tract structure
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment3 Interventions
Subjects will receive 4 gray (Gy) radiation in 2 fractions in the bridging period following lymphocyte pheresis, prior to lymphodepleting chemotherapy and chimeric antigen receptor (CAR) T-cell infusion. Post CAR T-cell infusion radiation therapy will be allowed as determined by study investigator but prespecified at time of radiation oncology consultation.
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Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,641 Previous Clinical Trials
4,130,031 Total Patients Enrolled
University of NebraskaLead Sponsor
539 Previous Clinical Trials
1,144,701 Total Patients Enrolled
Christopher D'Angelo, MDPrincipal InvestigatorUniversity of Nebraska
2 Previous Clinical Trials
38 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I need to take high dose methotrexate.My organs or blood counts are not healthy enough for strong chemotherapy.I am 19 years old or older.I am able to get out of my bed or chair and move around.My lymphoma has returned or worsened and fits the type for a specific treatment.My scans show cancer that can be safely targeted with radiation.I haven't had lymphoma treatment within 2 weeks before T-cell collection.I am willing to join the clinical trial and can give my consent.I have another cancer besides skin cancer that has been in remission for less than 2 years.My diagnosis is primary brain lymphoma, but it may have spread.My heart and lungs are healthy enough for CAR T-cell therapy, as per my doctor's assessment.I have been deemed unfit for radiation therapy by my doctor.
Research Study Groups:
This trial has the following groups:- Group 1: Single arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How does the Single arm approach affect patient safety?
"The safety of this single-arm trial was assessed as a 1 due to the limited evidence regarding its efficacy and safety."
Answered by AI
What is the scope of recruitment for this experiment?
"Affirmative. The information available on clinicaltrials.gov attests that this medical trial, which was initially announced on March 21st 2023, is actively enrolling participants. 33 individuals are required to be recruited from a single location."
Answered by AI
Are additional participants sought after for this experiment?
"Indeed, the clinical trial is currently recruiting participants according to data posted on clinicaltrials.gov. This study was first initiated in March 21st 2023 and has been updated as recently as May 4th 2023. 33 individuals must be sourced from a single medical centre for the duration of this experiment."
Answered by AI
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