← Back to Search

CAR T-cell Therapy

Radiotherapy Post-CAR T for Lymphoma

N/A
Waitlist Available
Led By Chirayu G Patel, MD, MPH
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 or older
At least 1 measurable lesion according to the Lugano criteria1. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up os is defined as the time from rt completion to the date of death up to 2 years
Awards & highlights

Study Summary

This trial is testing if using radiation therapy shortly after receiving CAR T cell therapy can help treat participants with refractory lymphoma.

Who is the study for?
This trial is for adults with refractory lymphoma who have had CAR T cell therapy but still show signs of cancer. They must be able to undergo a biopsy unless it's unsafe or the disease is clearly worsening, and they should not have severe ongoing side effects from previous treatments.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of radiotherapy on patients with stubborn lymphoma after receiving CAR T cell therapies axicel or tisacel. It aims to see if radiation can help where CAR T has been insufficient.See study design
What are the potential side effects?
Radiotherapy may cause skin irritation at the treatment site, fatigue, nausea, and in some cases could lead to more serious complications depending on which body parts are treated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I have at least one tumor that can be measured and has grown after radiation.
Select...
I can have a biopsy unless it's too risky or delays needed treatment.
Select...
I have multiple cancer sites not responding to treatment, with at least one causing symptoms or threatening vital areas like the brain or spinal canal.
Select...
Side effects from my previous treatments are mild or gone, except for hair loss or long-lasting low blood cell counts.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My cancer did not respond to recent CAR-T cell therapy.
Select...
I have one cancer lesion that hasn't responded to treatment, but no other growing cancer.
Select...
I have at least one cancer lesion that's not responding to treatment, but another has improved.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~os is defined as the time from rt completion to the date of death up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and os is defined as the time from rt completion to the date of death up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0
Secondary outcome measures
Duration of response (DOR)
Objective response rate (ORR) per IRRC
Overall All Survival
+1 more

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389
98%
Anemia
93%
Leukocytes decreased
90%
Lymphopenia
84%
Neutrophils decreased
78%
Neuropathy-sensory
75%
Alopecia
74%
Fatigue
67%
Nausea
60%
Hyperglycemia
52%
Constipation
46%
Hypoalbuminemia
40%
Myalgia
34%
Stomatitis
33%
Insomnia
32%
Vomiting
27%
Platelets decreased
26%
Alkaline phosphatase increased
26%
Aspartate aminotransferase increased
23%
Dyspnea
20%
Dyspepsia
19%
Dysphagia
19%
Headache
16%
Anorexia
16%
Arthralgia
15%
Neuropathy-motor
15%
Abdominal pain
14%
Infection w/o neutropenia
14%
Cough
14%
Fever
13%
Rash/desquamation
13%
Diarrhea w/o prior colostomy
12%
Bone pain
11%
Weight gain
11%
Taste disturbance
11%
Anxiety/agitation
10%
Sweating
10%
Radiation dermatitis
9%
Dizziness/lightheadedness
9%
Rigors/chills
9%
Injection site reaction
8%
Dysphagia-esophageal radiation
8%
Hypoglycemia
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
7%
Creatinine increased
7%
Edema
7%
Pruritus
6%
Hot flashes
6%
Infection w/ grade 3 or 4 neutropenia
6%
Weight loss
5%
Muscle weakness
5%
Depression
5%
Mouth dryness
4%
Transfusion: pRBCs
4%
Pneumonitis/pulmonary infiltrates
3%
Thrombosis/embolism
3%
Febrile neutropenia
3%
Irregular menses
3%
Nail changes
2%
Allergic rhinitis
1%
Allergic reaction
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)

Trial Design

1Treatment groups
Experimental Treatment
Group I: RadiotherapyExperimental Treatment1 Intervention
Participants must have received CAR-T infusion within the last 90 days prior to completing a study screening and enrollment process. Participants will be enrolled within 28 days after screening is complete and radiotherapy will occur within 14 days after study enrollment. Radiotherapy will be administered based on a dose and schedule pre-determined by the study doctor.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiotherapy
2017
Completed Phase 3
~2610

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,918 Previous Clinical Trials
13,192,815 Total Patients Enrolled
1 Trials studying Blood Cancers
90 Patients Enrolled for Blood Cancers
Chirayu G Patel, MD, MPHPrincipal InvestigatorMassachusetts General Hospital

Media Library

Axicabtagene Ciloleucel (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04473937 — N/A
Blood Cancers Research Study Groups: Radiotherapy
Blood Cancers Clinical Trial 2023: Axicabtagene Ciloleucel Highlights & Side Effects. Trial Name: NCT04473937 — N/A
Axicabtagene Ciloleucel (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04473937 — N/A

Frequently Asked Questions

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

Are any enrollees currently being accepted into this experiment?

"As per clinicaltrials.gov, the recruitment for this study is no longer active. The trial went live on July 1st 2021 and was last edited 19th of January 2021; however, 4073 other clinical studies are currently seeking participants."

Answered by AI
~5 spots leftby Mar 2025