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

NCT05019976 | Active Not Recruiting

• 1 other identifier: IRB21-0666
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma; Non-hodgkin Lymphoma; Hodgkin Lymphoma

Keywords

cancer; lymph nodes; cancer in lymph nodes

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose Per Fraction of Radiation

  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.

  1 Month

Secondary Outcomes (6)

• Rate of Reported Adverse Events Within 1 Month of Radiation

  1 Month

• 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

• Overall Response Rate to Radiation Treatment

  Up to 2 years after last dose of radiation

• Progression-Free Survival of Participants After Radiation Treatment

  Up to 2 years after last dose of radiation

• Overall Survival After Radiation Treatment

  Up to 2 years after last dose of radiation

Study Arms (5)

Dose-Finding Group 0 - Dose Level 0

EXPERIMENTAL

High-energy radiation will be delivered to a focused area of your body using a treatment machine called a linear accelerator. Radiation will be delivered through an IV. A mold will also be customized to fit your body, so you don't move during the radiation process. The actual time on the radiation treatment machine will be 30-60 minutes. The mold will be removed after the treatment. The longest possible treatment will be 14 radiation treatments over a course of 3 weeks. The shortest possible treatment will be 3 treatments in duration or less than 1 week. The amount of time required for radiation treatment depends on the dose group your are assigned. Participants will receive radiation to at least 1 but no more than 5 lesions (areas of body with cancer).

Radiation: Radiation - Dose Level 0

Dose-Finding Group 1 - Dose Level 1

EXPERIMENTAL

High-energy radiation will be delivered to a focused area of your body using a treatment machine called a linear accelerator. Radiation will be delivered through an IV. A mold will also be customized to fit your body, so you don't move during the radiation process. The actual time on the radiation treatment machine will be 30-60 minutes. The mold will be removed after the treatment. The longest possible treatment will be 14 radiation treatments over a course of 3 weeks. The shortest possible treatment will be 3 treatments in duration or less than 1 week. The amount of time required for radiation treatment depends on the dose group your are assigned. Participants will receive radiation to at least 1 but no more than 5 lesions (areas of body with cancer).

Radiation: Radiation - Dose Level 1

Dose-Finding Group 2 - Dose Level 2

EXPERIMENTAL

High-energy radiation will be delivered to a focused area of your body using a treatment machine called a linear accelerator. Radiation will be delivered through an IV. A mold will also be customized to fit your body, so you don't move during the radiation process. The actual time on the radiation treatment machine will be 30-60 minutes. The mold will be removed after the treatment. The longest possible treatment will be 14 radiation treatments over a course of 3 weeks. The shortest possible treatment will be 3 treatments in duration or less than 1 week. The amount of time required for radiation treatment depends on the dose group your are assigned. Participants will receive radiation to at least 1 but no more than 5 lesions (areas of body with cancer).

Radiation: Radiation - Dose Level 2

Dose-Finding Group 3 - Dose Level 3

EXPERIMENTAL

High-energy radiation will be delivered to a focused area of your body using a treatment machine called a linear accelerator. Radiation will be delivered through an IV. A mold will also be customized to fit your body, so you don't move during the radiation process. The actual time on the radiation treatment machine will be 30-60 minutes. The mold will be removed after the treatment. The longest possible treatment will be 14 radiation treatments over a course of 3 weeks. The shortest possible treatment will be 3 treatments in duration or less than 1 week. The amount of time required for radiation treatment depends on the dose group your are assigned. Participants will receive radiation to at least 1 but no more than 5 lesions (areas of body with cancer).

Radiation: Radiation - Dose Level 3

Dose-Finding Group 4 - Dose Level 4

EXPERIMENTAL

High-energy radiation will be delivered to a focused area of your body using a treatment machine called a linear accelerator. Radiation will be delivered through an IV. A mold will also be customized to fit your body, so you don't move during the radiation process. The actual time on the radiation treatment machine will be 30-60 minutes. The mold will be removed after the treatment. The longest possible treatment will be 14 radiation treatments over a course of 3 weeks. The shortest possible treatment will be 3 treatments in duration or less than 1 week. The amount of time required for radiation treatment depends on the dose group your are assigned. Participants will receive radiation to at least 1 but no more than 5 lesions (areas of body with cancer).

Radiation: Radiation - Dose Level 4

Interventions

Radiation - Dose Level 0 RADIATION

Dose Per Fraction (Each Radiation Treatment): 3.2Gy to 2.4Gy (minimal dose) depending on what study doctor prescribes Total Dose of Radiation for Treatment Period: 44.8Gy to 33.6Gy (minimal dose) depending on what study doctor prescribes Total Number of Radiation Treatments: 14

Dose-Finding Group 0 - Dose Level 0

Radiation - Dose Level 1 RADIATION

Dose Per Fraction (Each Radiation Treatment): 4.2Gy to 3.2Gy (minimal dose) depending on what study doctor prescribes Total Dose of Radiation for Treatment Period: 42Gy to 32Gy (minimal dose) depending on what study doctor prescribes Total Number of Radiation Treatments: 10

Dose-Finding Group 1 - Dose Level 1

Radiation - Dose Level 2 RADIATION

Dose Per Fraction (Each Radiation Treatment): 5.2Gy to 4.2Gy (minimal dose) depending on what study doctor prescribes Total Dose of Radiation for Treatment Period: 39.2Gy to 29.4Gy (minimal dose) depending on what study doctor prescribes Total Number of Radiation Treatments: 7

Dose-Finding Group 2 - Dose Level 2

Radiation - Dose Level 3 RADIATION

Dose Per Fraction (Each Radiation Treatment): 6.8Gy to 5.4Gy (minimal dose) depending on what study doctor prescribes Total Dose of Radiation for Treatment Period: 34Gy to 27Gy (minimal dose) depending on what study doctor prescribes Total Number of Radiation Treatments: 5

Dose-Finding Group 3 - Dose Level 3

Radiation - Dose Level 4 RADIATION

Dose Per Fraction (Each Radiation Treatment): 10Gy to 7.8Gy (minimal dose) depending on what study doctor prescribes Total Dose of Radiation for Treatment Period: 30Gy to 23.4Gy (minimal dose) depending on what study doctor prescribes Total Number of Radiation Treatments: 3

Dose-Finding Group 4 - Dose Level 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Written Informed Consent:
• Participants must be able to give self-consent and then sign and date an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent in accordance with local regulatory and institutional guidelines. This consent must be obtained before the performance of any protocol-related procedures that are not considered part of normal participant care.
• Participants must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.
• Must have the following disease/participant characteristics:
• Men or women ≥ 18 years of age.
• Must have clinically confirmed relapsed/refractory Hodgkin/non-Hodgkin lymphoma
• Mush have undergone appropriate standard of care treatment options (in the opinion of the treating investigator).
• Must have measurable disease/tumors as defined by RECIST Version 1.1, including at least one tumor lesion that meets criteria for radiation (0.25 cc to 65 cc of viable tumor approximately 5 cm in maximal dimension). Tumors larger than 65 cc can be partially treated but the whole tumor should receive at least the minimal prescribed dose.
• Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
• Must have adequate organ function, as defined by clinical lab values provided to the study doctor.
• Must have an doctor-determined life expectancy of at least 1 month.
• Participants who are women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 72 hours prior to the start of study.
• Participants who are women must not be breastfeeding.
• Participants who are WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) and up to 5 months post last dose of study drug(s).
• Participants who are WOCBP who are continuously not heterosexually active are exempted from contraceptive requirements but still must undergo pregnancy testing as described in this section.

You may not qualify if:

• Participants must not have an indolent lymphoma or other type of lymphoma which could be effectively treated with radiation doses substantially less then and EQD2 of 50 Gy
• Participants must not receive concurrent chemotherapy, targeted small molecule therapy, radiation or other anti-cancer therapy (with exceptions for disease-specific hormone treatments considered standard of care), anti-cancer monoclonal antibody (mAb) or have not recovered (i.e. \< grade 1 or at baseline) from adverse events due to a previously administered agent. Participants may receive concurrent steroids.
• i) Note: subjects with \< grade 2 neuropathy are an exception to this criterion and may qualify for the study.
• ii) Note: if subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
• iii) Note: subjects with any grade alopecia are an exception to this criterion and may qualify for the study
• Participants must not have had prior radiation therapy (defined as \>10% of prior prescription dose) to the area planning to be treated with radiation.
• Participants who have had prior cytotoxic chemotherapy must not receive that therapy within 2 weeks of the initiation of radiation
• Participants who have had prior anti-cancer monoclonal antibody (mAb) or other small molecules must not receive that therapy within 7 days of the initiation of radiation
• Participants must not have a known history of non-infectious pneumonitis that required steroids for treatment.
• Participants must not have evidence of interstitial lung disease.
• Participants must not have a current seizure disorder.
• Participants must not have a history or current evidence of any condition, therapy or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
• If known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected) then patient is not eligible for treatment of liver lesions

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Hodgkin Disease; Lymphoma; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yasmin Hasan, MD

  University of Chicago - Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: August 25, 2021
• Study Start: September 30, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)