A Study of Reduced Dose Radiation Therapy for People With B-Cell Lymphomas

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

The researchers are doing this study to find out whether a very low dose of radiation therapy (VLDRT) is an effective treatment for people with follicular lymphoma (FL) or marginal zone lymphoma (MZL) and works as well as the standard dose of radiation therapy. The researchers will see if VLDRT works against cancer in the area that is currently affected by cancer and if the therapy prevents new spots of lymphoma from developing. The researchers will also compare VLDRT with the standard dose of radiation therapy to see if VLDRT causes fewer side effects.

Radiation therapy uses beams of intense energy to kill cancer cells. Standard doses of radiation therapy can cause short- and long-term side effects. Researchers think VLDRT may be as effective as standard doses, and, because VLDRT uses less radiation, researchers think VLDRT may cause fewer side effects than standard doses.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Follicular lymphoma

WHO 5th Edition

Classic follicular lymphoma (cFL)

Follicular lymphoma with uncommon features (uFL)

Disqualifiers

Prior radiation to site(s) needing treatment

Follicular lymphoma, grade 3B (ICC) or Follicular large B cell lymphoma (FLBL by WHO 5th edition criteria)

Patients planned to receive concurrent systemic therapy (including oral steroids) for their lymphoma

Patient has cutaneous only iNHL defined as primary cutaneous B-cell lymphoma, primary cutaneous follicle center lymphoma, cutaneous marginal zone lymphoma or unspecified indolent lymphoma of the skin

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiation (Standard)

    Radiation

    24 Gy in 12 fractions

  • Radiation (Very low dose)

    Radiation

    4 Gy in 1-2 consecutive daily fractions

Treatment groups

375 Participants
are divided into 2 treatment groups
Group A: Very low dose of RadiationActive comparator 1 intervention
Group B: Standard dose of RadiationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

progression-free survival

Progression will be defined as either PD as per Lugano criteria (either treated or non-treated lesions) OR * Receipt of any additional radiotherapy for lymphoma to an initially involved site outside of the protocol mandated treatment OR * Death from any cause

Time frame
2 years

Secondary outcomes

1

radiographic response

using Lugano criteria

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

The Leukemia and Lymphoma Society

Collaborator