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CAR T-cell Therapy

Radiation Therapy + CAR T-Cell Therapy for Lymphoma

Phase < 1

Recruiting

Led By Savita V Dandapani

Research Sponsored by City of Hope Medical Center

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 1 year

Awards & highlights

Study Summary

This trial tests giving radiation therapy to LBCL patients before CAR T-cell therapy to slow disease progression and improve outcomes.

Who is the study for?

Adults with large B-cell lymphoma that has returned or hasn't responded to treatment, who are planning CAR T-cell therapy within 3 months. They must have recovered from previous cancer treatments, be in relatively good health (ECOG <=2 or KPS >=60), and not be pregnant. Excluded are those with active infections, diarrhea, CNS disease, recent radiation therapy, prior CD19-directed therapy, or any condition making study participation unsafe.Check my eligibility

What is being tested?

The trial is testing if bridging radiation therapy before CAR T-cell infusion can improve outcomes for patients with relapsed/refractory large B-cell lymphoma. It aims to control the disease while waiting for the personalized immune cell treatment (CAR T-cells) grown from the patient's own blood to become ready for infusion.See study design

What are the potential side effects?

Potential side effects include typical reactions to radiation like skin irritation and fatigue as well as possible acute toxicities related to CAR T-cell infusion which may involve fever, difficulty breathing, rapid heartbeat and a drop in blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

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

Proportion of participants completing planned radiation therapy

Secondary outcome measures

Complete response rate

Distant control

Incidence of AEs

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (leukapheresis, external beam radiation, CAR-T)Experimental Treatment7 Interventions

Patients undergo leukapheresis per standard of care, undergo external beam radiation therapy, and undergo CAR T-cell infusion per standard of care on study. Patients undergo PET/CT throughout the study and may undergo MRI during screening. Patients also undergo blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2008

Completed Phase 2

~2240

Biospecimen Collection

2004

Completed Phase 2

~1700

Computed Tomography

2017

Completed Phase 2

~2720

External Beam Radiation Therapy

2006

Completed Phase 3

~3070

Leukapheresis

2016

Completed Phase 2

~690

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

567 Previous Clinical Trials

1,922,651 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,670 Previous Clinical Trials

40,926,727 Total Patients Enrolled

Savita V DandapaniPrincipal InvestigatorCity of Hope Medical Center

3 Previous Clinical Trials

34 Total Patients Enrolled

Media Library

Chimeric Antigen Receptor T-Cell Therapy (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05800405 — Phase < 1

Diffuse Large B-Cell Lymphoma Research Study Groups: Treatment (leukapheresis, external beam radiation, CAR-T)

Diffuse Large B-Cell Lymphoma Clinical Trial 2023: Chimeric Antigen Receptor T-Cell Therapy Highlights & Side Effects. Trial Name: NCT05800405 — Phase < 1

Chimeric Antigen Receptor T-Cell Therapy (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05800405 — Phase < 1

Frequently Asked Questions

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

Is the enrollment period still open for this investigation?

"Clinicaltrials.gov states that this study is no longer recruiting patients, with the initial post on August 23rd 2023 and a final update on March 24th 2023. However, there are an abundance of other medical trials actively searching for participants at present - 1753 to be precise!"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of Bridging Radiation Therapy Before CAR T-Cell Infusion for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma

2023. "Evaluation of Bridging Radiation Therapy Before CAR T-Cell Infusion for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05800405.