Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma

Not Applicable

Active, not recruiting

• Conditions: Non-hodgkin Lymphoma; Hodgkin Lymphoma; Lymphoma

• Registration Number: NCT05019976
• Lead Sponsor: University of Chicago

Brief Summary

This study focuses on using shortened courses of radiation for participants with relapsed/refractory Hodgkin/Non-Hodgkin lymphoma. Treatment radiation over 5-6 weeks is often standard of care for many people with lymphoma, but doctors leading this study aim to find out if using radiation for a shorter period of time can be safe for treating lymphoma and if so, what is the safest shortened dose of radiation for participants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-20
• Study First Submitted QC: 2021-08-20
• Study First Posted: 2021-08-25
• Study Start: 2021-09-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-12
• Primary Completion: 2027-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose Per Fraction of Radiation	1 Month	Maximum tolerated dose of radiation per fraction among participants with relapsed/refractory Hodgkin/non-Hodgkin lymphoma as assessed by dose-limiting toxicities (severe side effects that limit the dose of radiation) defined by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate to Radiation Treatment	Up to 2 years after last dose of radiation	Overall response rate to radiation (including irradiated and non-irradiated lesions) as assessed by computed tomography scans of lesions based on tumor measurements according to Response Evaluation Criteria in Solid Tumors (RECIST criteria Version 1.1 ).
Local Control of Treated Lesions After Radiation Treatment	Up to 2 years after last dose of radiation	Local control of the treated lesion as assessed by computed tomography (CT) scans of lesions, tumor measurements according to Response Evaluation Criteria in Solid Tumors (RECIST criteria Version 1.1 ) and clinical records.
Rate of Reported Adverse Events Within 1 Month of Radiation	1 Month	The rate of reported adverse events (side effects) within 1 month of starting radiation as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Rate of Long-Term Adverse Events (Up to 2 Years) From the End of Radiation Rate of Long-Term Adverse Events (Up to 2 Years) From the End of Radiation	Up to 2 years after last dose of radiation	The rates of reported long-term adverse events from the end of radiation up to a maximum of 2 years as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Progression-Free Survival of Participants After Radiation Treatment	Up to 2 years after last dose of radiation	Progression-free survival after radiation as assessed by computed tomography (CT) scans of lesions, tumor measurements according to Response Evaluation Criteria in Solid Tumors and clinical records.
Overall Survival After Radiation Treatment	Up to 2 years after last dose of radiation	Overall survival after radiation as assessed by computed tomography (CT) scans of lesions, tumor measurements according to Response Evaluation Criteria in Solid Tumors(RECIST Version 1.1) and clinical records.

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States