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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT06386315
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Computed Tomography — PROCEDURE
    Undergo CT or PET/CT
  • Endoscopic Procedure — PROCEDURE
    Undergo endoscopy
  • Involved-site Radiation Therapy (3 Fractions) — RADIATION
    Undergo ISRT in 3 fractions
  • Involved-site Radiation Therapy (12 Fractions) — RADIATION
    Undergo ISRT in 12 fractions
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
May 15, 2024
Status verified
Apr 2026
Primary completion
May 30, 2027
Completion
May 30, 2027

Study Design

Enrollment
112 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ARM 1 (reduced dose ISRT)
    Patients undergo reduced dose ISRT once daily (excluding weekends): 9 Gy delivered in 3 treatment fractions or 8 Gy in 2 fractions. At physician discretion, patients may receive 10 Gy in 5 fractions. Patients also undergo CT or PET/CT throughout the study. Patients may additionally undergo endoscopy during screening and during follow up.
  • Active Comparator: ARM 2 (SOC ISRT)
    Patients undergo standard of care (SOC) radiation therapy once daily (excluding weekends): 24 Gy in 12 treatment fractions. Patients also undergo CT or PET/CT throughout the study. Patients may additionally undergo endoscopy during screening and during follow up.

Primary Outcome Measure

Incidence of grade 2 or higher acute adverse events (AEs) [ Time Frame: Up to 14 days after radiation treatment ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259
Clinical Trials Referral Office
[email protected]
855-776-0015
William G. Rule, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials Referral Office
[email protected]
855-776-0015
Brad S. Hoppe, MD, MPH (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Health System in Albert LeaAlbert LeaMinnesota56007
Clinical Trials Referral Office
[email protected]
855-776-0015
John Yeakel, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Health System - MankatoMankatoMinnesota56001
Clinical Trials Referral Office
[email protected]
855-776-0015
Jason T. Hayes, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Scott C. Lester, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Health System-Eau Claire ClinicEau ClaireWisconsin54701
Clinical Trials Referral Office
[email protected]
855-776-0015
Now Bahar Alam, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Health System-Franciscan HealthcareLa CrosseWisconsin54601
Clinical Trials Referral Office
[email protected]
855-776-0015
Abigail L. Stockham, MD (PRINCIPAL_INVESTIGATOR)

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