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Radiation Therapy for Non-Hodgkin's Lymphoma
Phase 1 & 2
Recruiting
Led By Kiran Kumar, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prior treatment with any CD19-directed CAR T-cell therapy, such as tisagenlecleucel (tisa-cel, Kymriah), axicabtagene ciloleucel (axi-cel, Yescarta), or lisocabtagene maraleucel (liso-cel)
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is studying the safety and efficacy of focal 're-priming' radiation therapy to FDG-avid residual sites of disease in relapsed/refractory non-Hodgkin lymphoma patients with incomplete response to CAR T-cell therapy by day 30 post-CAR-T PET/CT.
Who is the study for?
Adults over 18 with certain types of non-Hodgkin lymphoma who didn't fully respond to previous CAR T-cell therapy can join. They must be in relatively good health, understand the study, and agree to use birth control. People with brain involvement by cancer, severe side effects from prior treatments, very short life expectancy or conditions that could limit following the trial rules cannot participate.Check my eligibility
What is being tested?
The trial is testing if adding focal radiation therapy to areas where cancer remains after CAR T-cell treatment helps patients achieve a complete response. It's an early phase trial aiming to see if this approach is safe and more effective than past results without radiation.See study design
What are the potential side effects?
Potential side effects include typical reactions related to radiation such as skin redness, fatigue, hair loss at the treated site, nausea or other localized symptoms depending on the area being treated.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have previously received a CD19 CAR T-cell therapy.
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I am 18 years old or older.
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I have a confirmed diagnosis of a specific type of aggressive lymphoma.
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I can take care of myself and am up and about more than half of my waking hours.
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My cancer did not fully respond to CAR-T therapy as shown by a PET scan.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Craniosynostosis
Rate of Metabolic Complete Response (CR) on Day 90 Post-CAR-T PET/CT scan per Lugano 2014 Classification [Phase 2: Efficacy]
Secondary outcome measures
Duration of response (DOR) in Participants with Any Response as Noted on Day 90 Post-CAR-T PET/CT
Overall survival (OS)
Progression free survival (PFS)
+1 moreOther outcome measures
Biomarkers in serum and tumor samples
Level of Circulating CAR-T cells in the Peripheral Blood as Measured by Digital PCR and/or Flow Cytometry
Trial Design
1Treatment groups
Experimental Treatment
Group I: Radiation Therapy to all residual FDG-avid sites*Experimental Treatment1 Intervention
All patients enrolled in the trial will receive focal radiation therapy (RT) to all* residual FDG-avid sites per Lugano criteria (Lugano 4-5) as noted on day 30 post-CAR-T PET/CT scan.
*If >5 distinct sites, physician discretion will be allowed as to how many sites are treated, with recommendation that at least all symptomatic and bulky (>=7.5 cm in largest dimension) sites be treated.
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,057 Previous Clinical Trials
1,055,095 Total Patients Enrolled
Kiran Kumar, MDPrincipal Investigator - University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
1 Previous Clinical Trials
46 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had specific radiation therapy for areas where my cancer didn't fully respond after CAR-T treatment.I have previously received a CD19 CAR T-cell therapy.I do not have severe side effects from CAR-T therapy.I am 18 years old or older.You have a mental health condition or social situation that would make it difficult for you to follow the study guidelines.I have a confirmed diagnosis of a specific type of aggressive lymphoma.I am a woman capable of becoming pregnant.I do not have any serious illnesses or social situations that would stop me from following the study rules.I agree to use effective birth control during and for 90 days after the study.I can take care of myself and am up and about more than half of my waking hours.My cancer has spread to my brain and hasn't fully responded to CAR-T therapy.My cancer did not fully respond to CAR-T therapy as shown by a PET scan.I have a history of autoimmune disease or a condition that prevents radiation therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Radiation Therapy to all residual FDG-avid sites*
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.
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