Trial Outcomes & Findings for Radiation Post-CAR T in Refractory Lymphoma (NCT NCT04473937)

Last Updated: 2025-09-24

Results Overview

Rate and severity of radiotherapy-related toxicity as per CTCAE v5.0 (Common Terminology Criteria for Adverse Events) during radiotherapy (RT) or within the first 30 days of completing RT. The number of participants who experienced radiotherapy-related toxicities are listed below.

Recruitment status

TERMINATED

Study phase

Target enrollment

3 participants

Primary outcome timeframe

30 days

Results posted on

2025-09-24

Participant Flow

Participant milestones

Participant milestones
Measure	Radiotherapy 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. Radiotherapy: Radiotherapy at pre-determined dose and schedule
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radiation Post-CAR T in Refractory Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiotherapy n=3 Participants 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. Radiotherapy: Radiotherapy at pre-determined dose and schedule
Age, Continuous	79 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	2 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Radiotherapy n=3 Participants 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. Radiotherapy: Radiotherapy at pre-determined dose and schedule
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0 Grade 2 dermatitis	1 Participants
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0 Grade 1 Dysgeusia	1 Participants
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0 Grade 1 Skin hyperpigmentation	1 Participants
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0 Grade 1 Skin ulceration	1 Participants
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0 Grade 1 Anorexia	1 Participants
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0 Grade 1 Neck Edema	1 Participants
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0 Grade 1 Fatigue	1 Participants
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0 Grade 1 Nausea	1 Participants
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0 Total number of participants who experienced one or more RT-related toxicities, as described above	2 Participants

SECONDARY outcome

Timeframe: Up to 2 years

DOR is defined as the length of time between a subject's first objective response per Lugano criteria (complete response or partial response) and local disease progression per Lugano criteria, or death regardless of cause.

Outcome measures

Outcome measures
Measure	Radiotherapy n=3 Participants 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. Radiotherapy: Radiotherapy at pre-determined dose and schedule
Duration of Response (DOR)	7.33 months Interval 0.0 to 22.0

SECONDARY outcome

Timeframe: Up to 2 years

ORR is defined as the incidence of either a complete response or a partial response by Lugano criteria. All subjects that do not meet the criteria for an objective response by the analysis data cutoff date will be considered non-responders.

Outcome measures

Outcome measures
Measure	Radiotherapy n=3 Participants 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. Radiotherapy: Radiotherapy at pre-determined dose and schedule
Objective Response Rate (ORR)	3 Participants

SECONDARY outcome

Timeframe: Up to 2 years

PFS is defined as the time from radiotherapy completion date to the date of disease progression per Lugano criteria or death from any cause. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.

Outcome measures

Outcome measures
Measure	Radiotherapy n=3 Participants 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. Radiotherapy: Radiotherapy at pre-determined dose and schedule
Progression-free Survival (PFS)	0.67 months Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: Up to 2 years

Overall survival is defined as the time from radiotherapy completion to the date of death. Subjects who have not died by the analysis cutoff date will be censored at their last contact date.

Outcome measures

Outcome measures
Measure	Radiotherapy n=3 Participants 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. Radiotherapy: Radiotherapy at pre-determined dose and schedule
Overall Survival	7.33 months Interval 0.0 to 22.0

Adverse Events

Radiotherapy

Serious events: 0 serious events

Other events: 3 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Radiotherapy n=3 participants at risk 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. Radiotherapy: Radiotherapy at pre-determined dose and schedule
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
Blood and lymphatic system disorders Anemia	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
Metabolism and nutrition disorders Anorexia	66.7% 2/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
Eye disorders Blurred vision	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
Musculoskeletal and connective tissue disorders Bone pain	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
Injury, poisoning and procedural complications Bruising	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
Nervous system disorders Dysgeusia	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
Gastrointestinal disorders Dyspepsia	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
Respiratory, thoracic and mediastinal disorders Epistaxis	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
Injury, poisoning and procedural complications Fall	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
General disorders Fatigue	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
Blood and lymphatic system disorders Febrile neutropenia	66.7% 2/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
General disorders Fever	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
Gastrointestinal disorders Flatulence	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
Injury, poisoning and procedural complications Fracture	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
Metabolism and nutrition disorders Hypophosphatemia	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
Psychiatric disorders Insomnia	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
Investigations Lymphocyte count decreased	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
Gastrointestinal disorders Nausea	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
General disorders Neck edema	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
Nervous system disorders Peripheral sensory neuropathy	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
Investigations Platelet count decreased	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
Skin and subcutaneous tissue disorders Skin ulceration	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.
Skin and subcutaneous tissue disorders Radiation Dermatitis	33.3% 1/3 • All adverse events are reported from enrollment through 3 months after radiation therapy. After 3 months, targeted adverse events (neurological, hematological, infections, autoimmune disorders, and secondary malignancies) are reported for 6 months after treatment with axicel or tisacel or until disease progression, whichever occurs first. All cause mortality was monitored for up to two years.

Additional Information

Chirayu Patel, MD

Massachusetts General Hospital

Phone: 617-724-9627

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place