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

Mantle Cell Lymphoma Clinical Trial

Official title:

5-5-5 Adaptive Bridging Radiation Therapy (ABRT) for Relapsed/Refractory B-cell Lymphoma Prior to CAR T-cell Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06004167
• Other study ID #: 23-364
• Status: Recruiting
• Phase: N/A
• Start date: January 14, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: April 2024
• Source: Massachusetts General Hospital
• Contact: Chirayu Patel, MD
• Phone: (617) 724-2430
• Email: cpatel[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Radiation:
• Adaptive Bridging Radiation Therapy (ABRT)
Radiation Therapy

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Varian Medical Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: Percent of patients able to undergo ABRT	Feasibility is being measured based on the percentage of patients being able to undergo ABRT	20 months
Secondary	Adverse Events	Adverse events will be classified and graded according to the CTCAE v.5.0.	20 months
Secondary	Objective Response Rate (ORR)	ORR is being measured using the day 30 and day 90 PET scans and assessed by Lugano lymphoma response criteria	15 months