NCT05929612

A Study of Response Adapted Ultra Low Dose 4 Gy Radiation for Definitive Therapy of Marginal Zone Lymphoma

A Phase II Study of Response Adapted Ultra Low Dose 4 Gy Radiation for Definitive Therapy of Marginal Zone Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if response-adapted, ultra-low dose radiation therapy can help to control MZL. This means participates first receive lower does of radiation therapy and then, based on how the disease responds, may receive higher doses after that.

Detailed description

Primary Objectives: --To evaluate the efficacy of response adapted ultra low dose therapy (4 Gy with additional 12 Gy if needed) as a complete response after completion of the program Secondary Objectives: * To evaluate distant recurrence of marginal zone lymphoma at 24 months * To evaluate in field relapse at 24 months for all patients * To evaluate the efficacy of response adapted ultra low dose therapy (4 Gy with additional 12 Gy if needed) as overall response rate (ORR) after completion of the program * To evaluate overall survival of patients included in the study Exploratory Objectives: * To determine if microbiome assessment can predict response to ultra low dose radiation therapy and evaluate the differences in patient microbiome for patients who respond well and poorly to low dose radiation. * To encourage optional co-enrollment on study PA18-0644 to facilitate collection and archiving of blood-based biomarkers and microbiome samples for patients receiving ultra low dose radiation therapy. * To evaluate PETCT-based features for any patients receive PETCT for initial and follow up assessments.

Conditions

• Lymphoma

Interventions

Type	Name	Description
RADIATION	Ultra Low Dose 4 Gy Radiation	4 Gy in 2 fractions

Timeline

• Start date: 2023-07-28
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2023-07-03
• Last updated: 2026-01-09

Locations

1 site across 1 country: United States