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

Indolent B-Cell Non-Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06386315
• Other study ID #: MC230808
• Secondary ID: NCI-2024-0324223
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2024
• Est. completion date: May 30, 2024

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

PRIMARY OBJECTIVE: I. To show that 9 Gy in 3 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: I. 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: I. 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: I. 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 1: Patients undergo reduced dose ISRT once daily (QD) over 3 treatment fractions. Patients also undergo CT or PET/CT throughout the study. Patients may additionally undergo endoscopy during screening and during follow up. ARM 2: 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, 3 months then every 6 months for up to 2 years.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, 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
• 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
• Confirmation from radiation oncologist of suitability to participate in study

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

Related Conditions & MeSH terms

• Indolent B-Cell Non-Hodgkin Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Recurrence
• Refractory Indolent Non-Hodgkin Lymphoma

Intervention

Procedure:
• Computed Tomography
Undergo CT or PET/CT
• Endoscopic Procedure
Undergo endoscopy

Radiation:
• Involved-site Radiation Therapy (3 Fractions)
Undergo ISRT in 3 fractions
• Involved-site Radiation Therapy (12 Fractions)
Undergo ISRT in 12 fractions

Procedure:
• Positron Emission Tomography
Undergo PET/CT

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	Up to 3 months after radiation treatment
Secondary	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).	Up to 24 months after radiation treatment
Secondary	Patient reported quality of life	Patient reported quality of life will be measured using Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue 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).	Up to 3 months after radiation treatment