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Indolent B-Cell Non-Hodgkin LymphomaPhase 2NCT06386315

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

A Phase 2 study testing Computed Tomography, Endoscopic Procedure and Involved-site Radiation Therapy (3 Fractions) in people with Indolent B-Cell Non-Hodgkin Lymphoma and Recurrent Indolent B-Cell Non-Hodgkin Lymphoma, run by Mayo Clinic at 7 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Computed Tomography, Endoscopic Procedure and Involved-site Radiation Therapy (3 Fractions)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
7 sitesUnited States
Study dates
15 May 2024to 30 May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Referral Office contact

855-776-0015

mayocliniccancerstudies@mayo.edu

7 sites in 1 country

United States7 sites, 7 recruiting

  • Mayo Clinic Health System in Albert Lea

    Albert Lea, Minnesota, 56007

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

    John Yeakel, MD

    Recruiting

  • Mayo Clinic Health System-Eau Claire Clinic

    Eau Claire, Wisconsin, 54701

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

    Now Bahar Alam, MD

    Recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

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

    Brad S. Hoppe, MD, MPH

    Recruiting

  • Mayo Clinic Health System-Franciscan Healthcare

    La Crosse, Wisconsin, 54601

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

    Abigail L. Stockham, MD

    Recruiting

  • Mayo Clinic Health System - Mankato

    Mankato, Minnesota, 56001

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

    Jason T. Hayes, MD

    Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

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

    Scott C. Lester, MD

    Recruiting

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

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

    William G. Rule, MD

    Recruiting

Other trials in United States

About this study

Official title: MC230808 Reduced Dose Hypofractionated Radiotherapy (3Gy x 3 Fractions) for Indolent Non-Hodgkin Lymphoma (POSEIDON): A Multisite Phase 2 Randomized Trial

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To show that the experimental arm [9 gray (Gy) in 3 fractions, 8 Gy in 2 fractions, or 10 Gy in 5 fractions] has significantly reduced acute toxicity (grade ≥ 2 adverse events at least possibly related to radiation treatment within 14 days after the end of radiation treatment [according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0] compared to 24 Gy in 12 fractions.

SECONDARY OBJECTIVES:

  1. To evaluate patient reported quality of life. II. To evaluate response rate. III. To evaluate local control rate. IV. To evaluate relapse-free survival.

EXPLORATORY OBJECTIVES:

  1. Financial toxicity will be assessed at the end of radiation treatment. II. Financial health care expenditure will be assessed at the end of radiation treatment III. Late toxicity.

CORRELATIVE RESEARCH OBJECTIVES:

  1. Biopsies of enrolled patients will be evaluated for pathological assessment of cellular and genetic mutations to correlate them with disease local relapse and radiation resistance.

II. Patients will have their baseline positron emission tomography (PET)/computed tomography (CT) scan undergo auto-segmentation to calculate the functional imaging 18-fluoro-deoxyglucose (FDG) metabolic tumor volume (MTV), total lesions glycolysis (TLG) and maximum standardized uptake volume (SUVmax) of the sites to be treated with involved-site radiation therapy (ISRT) using MIMvista platform to correlate it with disease local relapse and treatment response.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo reduced dose ISRT once daily (QD) over 3, 2, or 5 treatment fractions. Patients also undergo CT or PET/CT throughout the study. Patients may additionally undergo endoscopy during screening and during follow up.

ARM II: Patients undergo standard of care (SOC) radiation therapy QD over 12 treatment fractions. Patients also undergo CT or PET/CT throughout the study. Patients may additionally undergo endoscopy during screening and during follow up.

After completion of study treatment, patients are followed up at days 7 and 14, months 3 and 6, and then every 6 months for up to 2 years post-radiation therapy.

Being tested
Computed Tomography, Endoscopic Procedure, Involved-site Radiation Therapy (3 Fractions), Involved-site Radiation Therapy (12 Fractions), Positron Emission Tomography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT or PET/CT

  • Endoscopic ProcedureProcedure or surgery

    Also called Endoscopic Examination, Endoscopy, ES

    Undergo endoscopy

  • Involved-site Radiation Therapy (3 Fractions)Radiation

    Also called ISRT

    Undergo ISRT in 3 fractions

  • Involved-site Radiation Therapy (12 Fractions)Radiation

    Also called ISRT

    Undergo ISRT in 12 fractions

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT06386315
Study groupRoleWhat they receive
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.
Receives: Procedure: Computed Tomography; Procedure: Endoscopic Procedure; Radiation: Involved-site Radiation Therapy (3 Fractions); Procedure: Positron Emission Tomography; Other: Questionnaire Administration
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.
Receives: Procedure: Computed Tomography; Procedure: Endoscopic Procedure; Radiation: Involved-site Radiation Therapy (12 Fractions); Procedure: Positron Emission Tomography; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Up to 14 days after radiation treatment

Secondary outcomes (3)

  1. Response rate

    Response rate will be defined as the proportion of patients displaying response (complete response or partial response) at 3 months post treatment. Complete response is defined as the disappearance of all signs of cancer in response to treatment. Partial response is defined decrease in the size of target lesions by ≥ 50%, with no increase in the size of any lesion and no appearance of new lesions. Treated patients who do not have a 3-month evaluation will be classified as a non-response. Treatment cycles are 5 days ±2 days (Arm 1) and 16 days ±2 days (Arm 2).

    Measured: Up to 3 months after radiation treatment

  2. Time to progression rate

    Local control will be defined as the number of days from end of radiation treatment until first local recurrence within 24 months post radiation treatment. Treatment cycles are 5 days ±2 days (Arm 1) and 16 days ±2 days (Arm 2).

    Measured: Up to 24 months after radiation treatment

  3. Patient reported quality of life

    Patient reported quality of life will be measured using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale, a 13-item questionnaire answered on a scale of 1-5 where 1=Not at all and 5=Very much. Treatment cycles are 5 days ±2 days (Arm 1) and 16 days ±2 days (Arm 2).

    Measured: Up to 3 months after radiation treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2024
  2. Study start15 May 2024
  3. Primary completion30 May 2027 (estimated)
  4. Study completion30 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06386315
Sponsor's protocol ID
MC230808
Other IDs
23-010273
Status last verified
Apr 2026
First submitted
23 Apr 2024
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Computed Tomography, Endoscopic Procedure and Involved-site Radiation Therapy (3 Fractions) in people with Indolent B-Cell Non-Hodgkin Lymphoma and Recurrent Indolent B-Cell Non-Hodgkin Lymphoma, run by Mayo Clinic at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of grade 2 or higher acute adverse events (AEs) (time frame: Up to 14 days after radiation treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06386315.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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