Reduced Dose Hypofractionated Radiotherapy For Indolent Non-hodgkin Lymphoma

Overview

About this study

The purpose of thisstudy is to evaluate reduction of radiotherapy dose for patients with indolent NHL by conducting a prospective randomized phase 2 study comparing reduced dose hypofractionated ISRT of 9 Gy delivered over 3 fractions (BED 12 Gy) to standard of care 24 Gy delivered over 12 fractions (BED 29Gy), while simultaneously evaluating prognostic value of pre-radiation functional imaging parameters and molecular markers to predict treatment response and failure.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  •  Age ≥ 18 years.
  • Histological confirmation of indolent B-cell lymphoma that can include any of the following:
    • Follicular lymphoma (grade 1 or 2 or 3A);
    •  Marginal zone lymphoma (Nodal or extranodal).
  •  Any stage disease.
  • Initial or relapsed disease. If relapse involves the site to be treated there must be evidence of disease progression.
  • ECOG Performance Status (PS) ≤ 4 (Appendix I).
  • Negative pregnancy test done ≤7 days prior to registration, for persons of childbearing potential only.
  • Provide written informed consent.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Willingness to provide optional tissue specimens for correlative research (see Section 17.0). If required at Registration (ALL sample types require this statement, if bone marrow, urine, etc., are mandatory, include similar statement).
  • 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.

Exclusion Criteria: 

  • Any of the following:
    • Pregnant women;
    • Nursing women;
    • Men or women of childbearing potential who are unwilling to employ adequate contraception.
  • T-cell lymphoma.
  • Small and chronic lymphocytic lymphoma.
  • Grade 3B follicular lymphoma.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 10/3/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Scott Lester, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Bradford Hoppe, M.D., M.P.H.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

William Rule, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available