Reduced Dose Radiotherapy for the Treatment of Indolent Non-Hodgkin Lymphoma
MC230808 Reduced Dose Hypofractionated Radiotherapy (3Gy x 3 Fractions) for Indolent Non-Hodgkin Lymphoma (POSEIDON): A Multisite Phase 2 Randomized Trial
2 other identifiers
interventional
112
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2024
Typical duration for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2024
CompletedFirst Posted
Study publicly available on registry
April 26, 2024
CompletedStudy Start
First participant enrolled
May 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2027
April 22, 2026
April 1, 2026
3 years
April 23, 2024
April 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of grade 2 or higher acute adverse events (AEs)
AEs will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Acute toxicity will be reported as a proportion calculated as the number of patients with acute toxicity divided by the total number of treatment patients. Treatment cycles are 5 days ±2 days (Arm 1) and 16 days ±2 days (Arm 2).
Up to 14 days after radiation treatment
Secondary Outcomes (3)
Response rate
Up to 3 months after radiation treatment
Time to progression rate
Up to 24 months after radiation treatment
Patient reported quality of life
Up to 3 months after radiation treatment
Study Arms (2)
ARM 1 (reduced dose ISRT)
EXPERIMENTALPatients 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.
ARM 2 (SOC ISRT)
ACTIVE COMPARATORPatients 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.
Interventions
Undergo CT or PET/CT
Undergo endoscopy
Undergo ISRT in 3 fractions
Undergo ISRT in 12 fractions
Undergo PET/CT
Eligibility Criteria
You may qualify if:
- 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)
- Follicle center lymphoma
- Any stage disease
- Initial, refractory, or relapsed disease. If relapse involves the site to be treated there must be evidence of disease progression
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 3
- 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
- Willing to return to enrolling institution for follow-up visits (during the active monitoring phase of the study). Virtual visits can also be considered as an option for applicable items
- Confirmation from radiation oncologist of suitability to participate in study
You may not qualify if:
- Any of the following:
- Pregnant women
- Nursing women
- Women of childbearing potential who are unwilling to employ adequate contraception
- T-cell lymphoma
- Receiving treatment for small and chronic lymphocytic lymphoma
- Grade 3B follicular lymphoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (7)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007, United States
Mayo Clinic Health System - Mankato
Mankato, Minnesota, 56001, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, 54701, United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brad S. Hoppe, MD, MPH
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2024
First Posted
April 26, 2024
Study Start
May 15, 2024
Primary Completion (Estimated)
May 30, 2027
Study Completion (Estimated)
May 30, 2027
Last Updated
April 22, 2026
Record last verified: 2026-04