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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 belowSelect...
I am 18 years old or older.
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I have at least one tumor that can be measured and has grown after radiation.
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I can have a biopsy unless it's too risky or delays needed treatment.
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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.
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I can take care of myself but might not be able to do heavy physical work.
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My cancer did not respond to recent CAR-T cell therapy.
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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ os is defined as the time from rt completion to the date of death up to 2 years
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
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 moreSide effects data
From 2016 Phase 3 trial • 854 Patients • NCT0000338998%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My cancer has spread, hasn't responded to CAR T cell therapy, but isn't causing focused symptoms or threatening my brain or spinal canal.I have at least one tumor that can be measured and has grown after radiation.I can have a biopsy unless it's too risky or delays needed treatment.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.Side effects from my previous treatments are mild or gone, except for hair loss or long-lasting low blood cell counts.I can take care of myself but might not be able to do heavy physical work.My cancer did not respond to recent CAR-T cell therapy.I am not pregnant, surgically sterilized, or have been postmenopausal for 2 years.I have one cancer lesion that hasn't responded to treatment, but no other growing cancer.I don't have any health issues that could affect the safety or results of the treatment.I have at least one cancer lesion that's not responding to treatment, but another has improved.
Research Study Groups:
This trial has the following groups:- Group 1: Radiotherapy
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.
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."
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