Study on Ultra Low Dose Radiation Therapy for Treating Marginal Zone Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05929612

Provider View

This clinical trial is exploring whether a very low dose of radiation therapy, adjusted based on the patient's response, can effectively control marginal zone lymphoma (MZL). Participants will initially receive a low dose of radiation, with the possibility of receiving a higher dose if needed.

Patient Parameters

Program Overview

The aim of this study is to find out if using a very low dose of radiation therapy, which can be adjusted based on how the cancer responds, can help control marginal zone lymphoma (MZL). Patients will start with a low dose of radiation and may receive a higher dose if the cancer does not respond well.

Description

This study is focused on evaluating the effectiveness of using a very low dose of radiation therapy (4 Gy) for treating marginal zone lymphoma, with the option to increase the dose to 12 Gy if necessary. The primary goal is to see if this approach can lead to a complete response in patients after treatment.

Secondary goals include:

  • Checking if the cancer returns in other parts of the body within 24 months.
  • Monitoring if the cancer comes back in the treated area within 24 months.
  • Assessing the overall response rate to the low dose radiation therapy.
  • Evaluating the overall survival of patients in the study.

Exploratory goals include:

  • Investigating if analyzing the microbiome (the collection of microorganisms in the body) can predict how well patients respond to the low dose radiation therapy.
  • Encouraging participation in a related study to collect and store blood and microbiome samples.
  • Evaluating features from PETCT scans for patients who undergo these scans for initial and follow-up assessments.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have stage I-II marginal zone lymphoma, confirmed by a pathology report.
  • Should not be planned for any systemic therapy before the first follow-up evaluation after radiation.
  • Must have biopsy-proven disease with evidence of residual disease before enrollment.
  • Prior systemic therapy is allowed if it was given before the most recent disease assessment.
  • Prior antibiotics or topical therapies for treating marginal zone lymphoma are allowed if given before the most recent disease assessment.
  • For gastric MALT lymphoma, specific testing for H. pylori and MALT1 translocation is required.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • Men must agree to use effective contraception during and after the study.
  • Must be able to understand and sign a written informed consent document.
  • Patients with large tumors (over 7.5 cm) are allowed.
  • Patients with other cancers that do not interfere with the study are eligible.

Exclusion Criteria

  • Patients with psychiatric or social issues that would prevent them from following the study requirements.
  • Pregnant women are excluded due to potential risks to the fetus.
  • Patients with other types of lymphoma besides marginal zone lymphoma.
  • Patients who have had radiation to the treatment site that would exceed safe levels.
  • Patients with active scleroderma under treatment are not eligible due to potential excessive toxicity.

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