Radiation Post-CAR T in Refractory Lymphoma

NCT04473937 | Terminated Results DMC FDA Device

• 1 other identifier: 19-861
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This study is evaluating the safety and efficacy of using radiotherapy in participants who have refractory lymphoma shortly after receiving CAR T cell therapy (axicel or tisacel).

Conditions

Hematologic Malignancy; Refractory Lymphoma

Keywords

Hematologic Malignancy; Refractory Lymphoma; CAR T cell therapy; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0

  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.

  30 days

Secondary Outcomes (4)

• Duration of Response (DOR)

  Up to 2 years

• Objective Response Rate (ORR)

  Up to 2 years

• Progression-free Survival (PFS)

  Up to 2 years

• Overall Survival

  Up to 2 years

Study Arms (1)

Radiotherapy

EXPERIMENTAL

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.

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

Radiotherapy at pre-determined dose and schedule

Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be able to undergo biopsy. Biopsy will be obtained for patients to exclude possibility of false negative residual FDG avidity on PET/CT that is not substantially increased relative to pre-CAR-T PET/CT. Exceptions are allowed for patients who have clearly progressive disease for whom delaying radiation therapy to obtain a biopsy may worsen outcome (such as cases of cord compression), and for patients for whom the risks of biopsy are high (such as patients with evidence for CNS involvement).
• Biopsy-confirmed refractory disease within 30-90 days following commercial axicabtagene ciloleucel or tisagenlecleucel therapy for a hematologic malignancy (these include relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma). Of note, 'refractory' refers to patients who had early refractory disease after CAR-T cell therapy and not to patients who have received CAR-T for refractory disease, but had complete response to CAR-T cell therapy.
• 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
• The following criteria pertain to pattern of progression:
• Patients may have one refractory lesion without other residual or progressive disease as per PET/CT
• Patients may have more than one refractory lesion, but with evidence for at least partial response of at least one other lesion as per PET/CT
• Patients with more than one site of refractory disease without evidence for at least partial response of at least one other lesion are eligible if they are:
• A. Symptomatic from a refractory lesion (such as cord compression or focal pain) or
• B. Have disease that can locally affect the spinal canal or brain if left untreated.
• Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1 (except for clinically non-significant toxicities such as alopecia and prolonged cytopenias that are not expected to worsen during RT) if there is concern for overlap of anticipated radiation-related toxicity and toxicity from prior therapy due to where the RT field is located.
• Age 18 or older
• Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Any medical condition likely to interfere with assessment of safety or efficacy of RT
• Patients with more than one site of disease without any evidence for response to CAR T cell therapy who are not focally symptomatic due to progressive disease or do not have disease that can locally affect the spinal canal or brain if left untreated
• Women of child-bearing potential who are pregnant because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential.
• In the investigators judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Lymphoma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Chirayu Patel, MD
• Organization: Massachusetts General Hospital

CPATEL@MGH.HARVARD.EDU

617-724-9627

Study Officials

• Chirayu G Patel, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 16, 2020
• Study Start: January 5, 2021
• Primary Completion: October 9, 2021
• Study Completion: July 3, 2023
• Last Updated: September 24, 2025
• Results First Posted: April 10, 2024

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)