Non-hodgkin LymphomaNCT05019976
Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma
A study testing Radiation - Dose Level 0, Radiation - Dose Level 1 and Radiation - Dose Level 2 in people with Non-hodgkin Lymphoma and Hodgkin Lymphoma, run by University of Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-hodgkin Lymphoma, Hodgkin Lymphoma, Lymphoma
- What is being tested?
- Radiation - Dose Level 0, Radiation - Dose Level 1 and Radiation - Dose Level 2
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2021to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- Participants who are males and who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) and up to 7 months post last dose of study drug(s). In addition, male participants must be willing to refrain from sperm donation during this time.
- Participants who are azoospermic males (males who dont ejaculate without sperm) are exempt from contraceptive requirements.
- Study doctors shall counsel WOCBP, and male participants who are sexually active with WOCBP, on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise on the use of highly effective methods of contraception, which have a failure rate of < 1% when used consistently and correctly.
Who cannot join
- 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.
- Note: subjects with < grade 2 neuropathy are an exception to this criterion and may qualify for the study.
- Note: if subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- 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.
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- 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 additional malignancy that could confuse analysis of on-study treatment. Inclusion of all study participants with more than one malignancy must be discussed and approved by the PI.
- 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
- Participants must not have had uncontrolled or significant cardiovascular disease including, but not limited to, any of the following:
- Myocardial infarction or stroke/transient ischemic attack within the past 6 months
- Uncontrolled angina within the past 3 months
- Any history of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
- History of other clinically significant heart disease (e.g. cardiomyopathy, congestive heart failure with New York Heart Association functional classification III to IV, pericarditis, significant pericardial effusion, or myocarditis)
- Cardiovascular disease-related requirement for daily supplemental oxygen therapy.
- Participants may not concomitantly use statins while on study. However, a patient using statins for over 3 months prior to study drug administration and in stable status without CK rise may be permitted to enroll.
- Participants may not have current or history of clinically significant muscle disorders (e.g. myositis), recent unresolved muscle injury, or any condition known to elevate serum CK levels.
- Participants must not be prisoners or be involuntarily incarcerated.
- Participants must not be compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An i3+3 Phase I Dose-per-Fraction Escalation Trial for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma
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
- Non-hodgkin Lymphoma, Hodgkin Lymphoma, Lymphoma
- Being tested
- Radiation - Dose Level 0, Radiation - Dose Level 1, Radiation - Dose Level 2, Radiation - Dose Level 3, Radiation - Dose Level 4
- Keywords
- cancer, lymph nodes, cancer in lymph nodes
- Medical subject headings
- Lymphoma, Non-Hodgkin, Hodgkin Disease, Lymphoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation - Dose Level 0Radiation
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
Radiation - Dose Level 1Radiation
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
Radiation - Dose Level 2Radiation
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
Radiation - Dose Level 3Radiation
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
Radiation - Dose Level 4Radiation
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: Radiation: Radiation - Dose Level 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Month
Secondary outcomes (6)
Rate of Reported Adverse Events Within 1 Month of Radiation
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.
Measured: 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
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.
Measured: Up to 2 years after last dose of radiation
Overall Response Rate to Radiation Treatment
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 ).
Measured: Up to 2 years after last dose of radiation
Progression-Free Survival of Participants After Radiation Treatment
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.
Measured: Up to 2 years after last dose of radiation
Overall Survival After Radiation Treatment
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.
Measured: Up to 2 years after last dose of radiation
Local Control of Treated Lesions After Radiation Treatment
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.
Measured: Up to 2 years after last dose of radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start30 Sep 2021
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yasmin Hasan, MD, Principal investigator, University of Chicago - Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019976
- Sponsor's protocol ID
- IRB21-0666
- Status last verified
- Dec 2025
- First submitted
- 20 Aug 2021
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An i3+3 Phase I Dose-per-Fraction Escalation Trial for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT05019976
- Acronym / sponsor ID
- IRB21-0666
- Conditions
- Non-hodgkin Lymphoma, Hodgkin Lymphoma, Lymphoma
- Keywords
- cancer, lymph nodes, cancer in lymph nodes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose-Finding Group 0 - Dose Level 0 | Experimental | Radiation: Radiation - Dose Level 0High-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). |
| Dose-Finding Group 1 - Dose Level 1 | Experimental | Radiation: Radiation - Dose Level 1High-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). |
| Dose-Finding Group 2 - Dose Level 2 | Experimental | Radiation: Radiation - Dose Level 2High-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). |
| Dose-Finding Group 3 - Dose Level 3 | Experimental | Radiation: Radiation - Dose Level 3High-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). |
| Dose-Finding Group 4 - Dose Level 4 | Experimental | Radiation: Radiation - Dose Level 4High-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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Signed Written Informed Consent:
- Must have the following disease/participant characteristics:
Key exclusion criteria (26 listed)
- 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.
- Note: if subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation - Dose Level 0Dose 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 | Radiation | Dose-Finding Group 0 - Dose Level 0 |
| Radiation - Dose Level 1Dose 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 | Radiation | Dose-Finding Group 1 - Dose Level 1 |
| Radiation - Dose Level 2Dose 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 | Radiation | Dose-Finding Group 2 - Dose Level 2 |
| Radiation - Dose Level 3Dose 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 | Radiation | Dose-Finding Group 3 - Dose Level 3 |
| Radiation - Dose Level 4Dose 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 | Radiation | Dose-Finding Group 4 - Dose Level 4 |
Primary outcome
Maximum Tolerated Dose Per Fraction of Radiation
Time frame: 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.
6 secondary outcomes
Rate of Reported Adverse Events Within 1 Month of Radiation
Time frame: 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
Time frame: Up to 2 years after last dose of radiation
Overall Response Rate to Radiation Treatment
Time frame: Up to 2 years after last dose of radiation
Progression-Free Survival of Participants After Radiation Treatment
Time frame: Up to 2 years after last dose of radiation
Overall Survival After Radiation Treatment
Time frame: Up to 2 years after last dose of radiation
Local Control of Treated Lesions After Radiation Treatment
Time frame: Up to 2 years after last dose of radiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasmin Hasan, MD principal investigator
University of Chicago - Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation - Dose Level 0, Radiation - Dose Level 1 and Radiation - Dose Level 2 in people with Non-hodgkin Lymphoma and Hodgkin Lymphoma, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose Per Fraction of Radiation (time frame: 1 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.