RECRUITING

Reduced Dose Radiotherapy for the Treatment of Indolent Non-Hodgkin Lymphoma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial compares the safety, side effects and effectiveness of reduced dose radiation therapy to standard of care dose radiation in treating patients with indolent non-Hodgkin lymphoma. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Standard of care radiation treatment for indolent non-Hodgkin lymphoma is usually delivered in 12 treatments. Studies have shown indolent lymphoma to be sensitive to radiation treatment, however, larger doses have higher rates of toxicities. A reduced radiation dose may be safe, tolerable and/or effective compared to standard of care radiation dose in treating patients with indolent non-Hodgkin lymphoma.

Official Title

Reduced Dose Hypofractionated Radiotherapy (3Gy X 3 Fractions) for Indolent Non-Hodgkin Lymphoma (POSEIDON): a Multisite Phase 2 Randomized Trial

Quick Facts

Study Start:2024-05-15
Study Completion:2026-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06386315

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Histological confirmation of indolent B-cell lymphoma that can include any of the following:
  3. * Follicular lymphoma (grade 1 or 2 or 3A)
  4. * Marginal zone lymphoma (nodal or extranodal)
  5. * Any stage disease
  6. * Initial, refractory, or relapsed disease. If relapse involves the site to be treated there must be evidence of disease progression
  7. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 3
  8. * Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only
  9. * Provide written informed consent
  10. * Ability to complete questionnaire(s) by themselves
  11. * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study). Virtual visits can also be considered as an option for applicable items
  12. * Confirmation from radiation oncologist of suitability to participate in study
  1. * Any of the following:
  2. * Pregnant women
  3. * Nursing women
  4. * Men or women of childbearing potential who are unwilling to employ adequate contraception
  5. * T-cell lymphoma
  6. * Small and chronic lymphocytic lymphoma
  7. * Grade 3B follicular lymphoma

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Bradford S. Hoppe, MD, MPH
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Bradford S. Hoppe, MD, MPH, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-15
Study Completion Date2026-05-30

Study Record Updates

Study Start Date2024-05-15
Study Completion Date2026-05-30

Terms related to this study

Additional Relevant MeSH Terms

  • Indolent B-Cell Non-Hodgkin Lymphoma
  • Recurrent Indolent B-Cell Non-Hodgkin Lymphoma
  • Refractory Indolent B-Cell Non-Hodgkin Lymphoma
  • Recurrent Indolent Non-Hodgkin Lymphoma
  • Refractory Indolent Non-Hodgkin Lymphoma