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CompletedNCT06004167Updated Dec 9, 2025

Adaptive Bridging RT in R/R B-cell Lymphoma (Pre-CAR T)

An interventional study of Adaptive Bridging Radiation Therapy (ABRT) in Lymphoma, B-Cell, Relapsed Cancer and Refractory Lymphoma, sponsored by Massachusetts General Hospital. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-09.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Oct 2024, 2 years ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Participants are invited to take part in this research study because they have relapsed (cancer has come back) or refractory (cancer has not responded to treatment) B-cell Lymphoma and will be undergoing CAR T-cell Therapy.

This research is being done to see if a new radiation therapy administration schedule will positively impact the logistics, time, cost, and side effects of radiation therapy.

In this research study, participants will receive radiation therapy once weekly for 5 weeks. This is a novel administration schedule and we're looking to see how this schedule impacts side effects participants may experience, the time spent receiving radiation therapy, how much radiation therapy participants can receive, and how effective this new schedule is.

Read the detailed description

This is a feasibility/pilot study of 5 Gy adaptive radiation administered every 5 business days (1 week apart) for 5 weeks prior to standard of care CAR T-cell therapy infusion. Approximately 10 participants with Relapsed/Refractory B-cell Lymphoma will take part in this research study. The primary objective is to assess the feasibility of once weekly radiation therapy for 5 weeks.

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Conditions studied

  • Lymphoma, B-Cell
  • Relapsed Cancer
  • Refractory Lymphoma
  • Diffuse Large B Cell Lymphoma
  • Mediastinal Large B-cell Lymphoma
  • High-grade B-cell Lymphoma
  • Follicular Lymphoma
  • Mantle Cell Lymphoma

Keywords

  • Relapsed/Refractory B-cell Lymphoma
03

In context

Lymphoma, B-Cell

1,411 studies on the registry are indexed under Lymphoma, B-Cell; 329 are open to participants now.

This study's enrollment of 10 is below the median of 36 across 1,218 interventional studies indexed under Lymphoma, B-Cell.

Browse Lymphoma, B-Cell studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of relapsed or refractory B-cell lymphoma (including, but not limited to diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, DLBCL arising from follicular lymphoma, follicular, and mantle cell lymphoma)
  • Being planned to undergo CAR T-cell therapy (patients can be enrolled prior to apheresis)
  • At least 1 measurable lesion according to the Lugano criteria35. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy. Re-irradiation is allowed for these patients. More than 1 lesion can be targeted as per radiation oncologist discretion. If disease is palpable, physical examination alone may be sufficient measurement for disease if a recent PET/CT or CT is not available as a radiologic measurement of the disease can be obtained during CT simulation.
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 3.
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

Exclusion Criteria:

  • Any medical condition likely to interfere with assessment of safety or efficacy of RT.
  • CNS-only disease as the site for bridging radiation therapy (which cannot be reliably evaluated on CT). Patients with CNS disease with extra-axial involvement that can be evaluated on CT remain eligible.
  • Patient likely unable to lay supine for 45 minutes
  • 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 investigator's 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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    5-5-5 Adaptive Bridging Radiation Therapy (ABRT)

    5 Gy of adaptive radiation delivered every 5 business days (1 week apart) for up to 5 weeks prior to CAR T-cell therapy infusion

    Radiation: Adaptive Bridging Radiation Therapy (ABRT)

Interventions

  • RadiationAdaptive Bridging Radiation Therapy (ABRT)

    Radiation Therapy

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What researchers measure

Primary outcomes

  1. Feasibility: Percent of patients able to undergo ABRT

    Feasibility is being measured based on the percentage of patients being able to undergo ABRT

    Time frame: 20 months

Secondary outcomes

  1. Adverse Events

    Adverse events will be classified and graded according to the CTCAE v.5.0.

    Time frame: 20 months

  2. Objective Response Rate (ORR)

    ORR is being measured using the day 30 and day 90 PET scans and assessed by Lugano lymphoma response criteria

    Time frame: 15 months

07

Study locations

2 sites
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
08

References and documents

Publications

  • Ababneh HS, Ng AK, Wan J, Walburn T, Zhu L, Bobic M, Johnson PC, Bredtfeld J, Leeman J, Soumerai J, Abramson JS, Barnes J, Takvorian R, Frigault MJ, Pursley J, Patel CG. 5-5-5 ABRT (Dose of 5 Gy per Fraction for up to 5 Fractions Over 5 Weeks Adaptive Bridging Radiation Therapy)-Artificial Intelligence Enters the CAR (-T) (Chimeric Antigen Receptor-T) in Relapsed/Refractory Large B Cell Lymphoma. Int J Radiat Oncol Biol Phys. 2025 Jul 15;122(4):936-948. doi: 10.1016/j.ijrobp.2025.03.023. Epub 2025 Apr 3. PubMed 40178467 ↗

Individual participant data

Plan to share: Yes — The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Supporting information: Study protocol, Sap, Icf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06004167
Lead sponsor
Massachusetts General Hospital
Collaborators
Varian Medical Systems
Responsible party
Chirayu Patel (Principal Investigator, Massachusetts General Hospital) — Principal investigator
First posted
Aug 22, 2023
Start date
Jan 14, 2024
Primary completion
Oct 1, 2024
Completion
Dec 1, 2024
Last update
Dec 9, 2025

Study contacts

Chirayu Patel, MD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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