LymphomaPhase 2NCT05929612
A Study of Response Adapted Ultra Low Dose 4 Gy Radiation for Definitive Therapy of Marginal Zone Lymphoma
A Phase 2 study testing Ultra Low Dose 4 Gy Radiation in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Ultra Low Dose 4 Gy Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2023to 31 Dec 2027
- Phase
- Phase 2
- 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
- Patients 18 years or older. Because no RT dosing data are currently available on the use of response adapted ultra low dose RT in patients <18 years of age, children are excluded from this study.
- Patients with stage I-II marginal zone lymphoma. Patients with a pathology report consistent with low grade B cell lymphoma, favor marginal zone lymphoma, are included. Other low grade lymphomas including follicular grade I/II and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) are ineligible.
- Patients should not be planned for any systemic therapy before the first follow up evaluation after radiation (intent is to treat with radiation therapy alone).
- Patients with biopsy-proven disease treated with another modality (such as systemic therapy) prior to radiation must have clinical or radiographic evidence of residual disease before enrollment. Patients with clinical and/or radiographic masses that are measurable will have dimensions noted prior to therapy. If an excisional biopsy is performed, patients should have clinically or radiographically apparent disease after biopsy (this does not apply to gastric MALT lymphoma patients).
- Prior systemic therapy is allowed, as long as administration is prior to most recent disease assessment by imaging, clinical exam, or endoscopy. There are no limits on the nature or amount of prior systemic therapy.
- Prior antibiotics intended to treat marginal zone lymphoma are allowed, as long as administration is prior to most recent disease assessment by imaging, clinical exam, or endoscopy.
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- Prior topical therapies (e.g. steroid) intended to treat cutaneous lymphoma are allowed, as long as administration is prior to most recent disease assessment by imaging, clinical exam, or endoscopy.
- For patients with gastric MALT lymphoma, H. pylori testing by immunohistochemistry on tissue biopsy is required on most recent pathologic specimen prior to protocol enrollment. Secondary testing for H. pylori with stool and/or urea breath tests and/or serum antigen is strongly recommended. Testing for the MALT1 translocation (t11:18) is strongly recommended if tissue for testing is available.
- Female patients with childbearing potential must have a negative serum or urine pregnancy test (βhCG) within 1 week of RT administration or have a documented pregnancy test refusal.
- The effects of RT on the developing human fetus are harmful. For this reason and because RT used in this trial is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of RT administration. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
- Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of RT administration, and 4 months after completion of RT administration.
- Ability to understand and the willingness to sign a written informed consent document.
- Patients with bulky tumors (>7.5 cm) are allowed.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Who cannot join
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because RT is an agent with the potential for teratogenic or abortifacient effects.
- Patients with other lymphoma diagnoses other than marginal zone lymphoma.
- Patients with a history of radiation to the treated site, if re-treatment would exceed known gastric or surrounding critical structure (e.g., bowel, spinal cord) tolerance.
- Patients with active scleroderma under treatment are ineligible as prior studies have shown excessive toxicity in scleroderma patients treated with RT.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Jillian Gunther, MD,PHD, 832-710-7864, jgunther@mdanderson.org
Jillian Gunther, MD,PHD
About this study
Official title: A Phase II Study of Response Adapted Ultra Low Dose 4 Gy Radiation for Definitive Therapy of Marginal Zone Lymphoma
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.
Read the 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
- Being tested
- Ultra Low Dose 4 Gy Radiation
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra Low Dose 4 Gy RadiationRadiation
4 Gy in 2 fractions
| Study group | Role | What they receive |
|---|---|---|
| Ultra Low Dose 4 Gy Radiation | Experimental | Participants will receive the ultra-low doses of radiation therapy over 1-2 days Receives: Radiation: Ultra Low Dose 4 Gy Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start28 Jul 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jillian Gunther, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929612
- Sponsor's protocol ID
- 2023-0237
- Other IDs
- NCI-2023-05151
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2023
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Response Adapted Ultra Low Dose 4 Gy Radiation for Definitive Therapy of Marginal Zone Lymphoma
- ClinicalTrials.gov ID
- NCT05929612
- Acronym / sponsor ID
- 2023-0237
- Conditions
- Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Jul 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultra Low Dose 4 Gy Radiation | Experimental | Radiation: Ultra Low Dose 4 Gy RadiationParticipants will receive the ultra-low doses of radiation therapy over 1-2 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients 18 years or older. Because no RT dosing data are currently available on the use of response adapted ultra low dose RT in patients <18 years of age, children are excluded from this study.
- Patients with stage I-II marginal zone lymphoma. Patients with a pathology report consistent with low grade B cell lymphoma, favor marginal zone lymphoma, are included. Other low grade lymphomas including follicular grade I/II and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) are ineligible.
- Patients should not be planned for any systemic therapy before the first follow up evaluation after radiation (intent is to treat with radiation therapy alone).
- Patients with biopsy-proven disease treated with another modality (such as systemic therapy) prior to radiation must have clinical or radiographic evidence of residual disease before enrollment. Patients with clinical and/or radiographic masses that are measurable will have dimensions noted prior to therapy. If an excisional biopsy is performed, patients should have clinically or radiographically apparent disease after biopsy (this does not apply to gastric MALT lymphoma patients).
- Prior systemic therapy is allowed, as long as administration is prior to most recent disease assessment by imaging, clinical exam, or endoscopy. There are no limits on the nature or amount of prior systemic therapy.
Key exclusion criteria (5 listed)
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because RT is an agent with the potential for teratogenic or abortifacient effects.
- Patients with other lymphoma diagnoses other than marginal zone lymphoma.
- Patients with a history of radiation to the treated site, if re-treatment would exceed known gastric or surrounding critical structure (e.g., bowel, spinal cord) tolerance.
- Patients with active scleroderma under treatment are ineligible as prior studies have shown excessive toxicity in scleroderma patients treated with RT.
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 |
|---|---|---|
| Ultra Low Dose 4 Gy Radiation4 Gy in 2 fractions | Radiation | Ultra Low Dose 4 Gy Radiation |
Primary outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: through study completion; an average of 1 year.
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 16 Jul 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
Jillian Gunther, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ultra Low Dose 4 Gy Radiation in people with Lymphoma, run by M.D. Anderson Cancer Center 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 19 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 16 Jul 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jillian Gunther, MD ((832) 710-7864, jgunther@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: through study completion; an average of 1 year.). 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 16 Jul 2026.