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

Primary Purpose

Lymphoma, B-Cell, Relapsed Cancer, Refractory Lymphoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adaptive Bridging Radiation Therapy (ABRT)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, B-Cell focused on measuring Relapsed/Refractory B-cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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.

Sites / Locations

  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse Events
Adverse events will be classified and graded according to the CTCAE v.5.0.
Objective Response Rate (ORR)
ORR is being measured using the day 30 and day 90 PET scans and assessed by Lugano lymphoma response criteria

Full Information

First Posted
August 16, 2023
Last Updated
August 29, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Varian Medical Systems
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1. Study Identification

Unique Protocol Identification Number
NCT06004167
Brief Title
Adaptive Bridging RT in R/R B-cell Lymphoma (Pre-CAR T)
Official Title
5-5-5 Adaptive Bridging Radiation Therapy (ABRT) for Relapsed/Refractory B-cell Lymphoma Prior to CAR T-cell Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 14, 2024 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Varian Medical Systems

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
5-5-5 Adaptive Bridging Radiation Therapy (ABRT)
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
Adaptive Bridging Radiation Therapy (ABRT)
Intervention Description
Radiation Therapy
Primary Outcome Measure Information:
Title
Feasibility
Description
Feasibility is being measured based on the percentage of patients being able to undergo ABRT
Time Frame
20 months
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Adverse events will be classified and graded according to the CTCAE v.5.0.
Time Frame
20 months
Title
Objective Response Rate (ORR)
Description
ORR is being measured using the day 30 and day 90 PET scans and assessed by Lugano lymphoma response criteria
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chirayu Patel, MD
Phone
(617) 724-2430
Email
cpatel@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chirayu Patel, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Ng, MD
Phone
617-394-2668
Email
andrea_ng@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Andrea Ng, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Partners Innovations team at http://www.partners.org/innovation

Learn more about this trial

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

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