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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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 more

Other 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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,047 Previous Clinical Trials

1,053,779 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

Focal radiation therapy (RT) Clinical Trial Eligibility Overview. Trial Name: NCT04601831 — Phase 1 & 2

Non-Hodgkin's Lymphoma Research Study Groups: Radiation Therapy to all residual FDG-avid sites*

Non-Hodgkin's Lymphoma Clinical Trial 2023: Focal radiation therapy (RT) Highlights & Side Effects. Trial Name: NCT04601831 — Phase 1 & 2

Focal radiation therapy (RT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04601831 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial currently accept new enrollees?

"Affirmative. Clinicaltrials.gov has established that this medical trial, which debuted on December 23rd 2020, is still recruiting patients. Approximately 20 individuals are sought from 1 clinical site."

Answered by AI

What is the ultimate aim of this research endeavor?

"This clinical trial will span two months to measure the Rate of Metabolic Complete Response (CR) on Day 90 Post-CAR-T PET/CT scan per Lugano 2014 Classification [Phase 2: Efficacy]. Secondary objectives include ascertaining Progression free survival (PFS), gauging individual site's response rates, and calculating Overall survival (OS)."

Answered by AI

How many participants are being recruited for the clinical trial?

"Affirmative. According to clinicaltrials.gov, the advertisement for this trial was published on December 23rd 2020 and recently revised on July 8th 2022 - indicating that it's actively seeking volunteers. This experiment requires 20 individuals at a single site to participate in its research activities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

'Re-Priming' RT After Incomplete Response to CAR-T in R/R NHL

Kiran Kumar 2020. "'Re-Priming' RT After Incomplete Response to CAR-T in R/R NHL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04601831.