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Official title A Study of Response Adapted Ultra Low Dose 4 Gy Radiation for Definitive Therapy of Marginal Zone Lymphoma
ClinicalTrials.gov ID: NCT05929612
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Patients with stage I-II marginal zone lymphoma. Patients with a pathology report consistent with low grade B cell lymphoma, favor marginal zone...
- Patients should not be planned for any systemic therapy before the first follow up evaluation after radiation (intent is to treat with radiation...
- Patients with biopsy-proven disease treated with another modality (such as systemic therapy) prior to radiation must have clinical or radiographic...
- Prior systemic therapy is allowed, as long as administration is prior to most recent disease assessment by imaging, clinical exam, or endoscopy...
You likely can't join if
- 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...
- Patients with active scleroderma under treatment are ineligible as prior studies have shown excessive toxicity in scleroderma patients treated with...
See the full eligibility criteria
Who can 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...
- 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...
- 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.
- 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...
- 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...
- 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...
- 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 how well it works assessment of the investigational regimen are eligible for...
What rules you out
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.