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NCT06386315 · ClinicalTrials.gov registry record · Phase 2
Reduced Dose Radiotherapy for the Treatment of Indolent Non-Hodgkin Lymphoma
A Phase 2 study of Indolent B-Cell Non-Hodgkin Lymphoma and Recurrent Indolent Non-Hodgkin Lymphoma, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 112
- Enrollment target
- 7
- Study locations
NCT06386315: Recruiting Phase 2 study of Indolent B-Cell Non-Hodgkin Lymphoma and Recurrent Indolent Non-Hodgkin Lymphoma, sponsored by Mayo Clinic.
NCT06386315 is a Phase 2 study of Indolent B-Cell Non-Hodgkin Lymphoma and Recurrent Indolent Non-Hodgkin Lymphoma that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 112 participants, above the 53-participant average among 6 other Indolent B-Cell Non-Hodgkin Lymphoma trials with a reported enrollment target (111% higher). The trial reports 7 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06386315, a Phase 2 study of Indolent B-Cell Non-Hodgkin Lymphoma and Recurrent Indolent Non-Hodgkin Lymphoma, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 112 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- PROCEDURE Endoscopic Procedure
- RADIATION Involved-site Radiation Therapy (3 Fractions)
- RADIATION Involved-site Radiation Therapy (12 Fractions)
Study Locations (7)
Minnesota
- Mayo Clinic Health System in Albert Lea - Albert Lea
- Mayo Clinic Health System - Mankato - Mankato
- Mayo Clinic in Rochester - Rochester
Wisconsin
- Mayo Clinic Health System-Eau Claire Clinic - Eau Claire
- Mayo Clinic Health System-Franciscan Healthcare - La Crosse
Arizona
- Mayo Clinic in Arizona - Scottsdale
Florida
- Mayo Clinic in Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2024-05-15 |
| Est. Completion | 2026-05-30 |
| Phase | Phase 2 |
What NCT06386315 shows while recruiting
NCT06386315 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 6 other Indolent B-Cell Non-Hodgkin Lymphoma trials with a reported enrollment target (111% higher).
The record links to 5 conditions, with Indolent B-Cell Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT06386315 lists 7 locations in 4 states (Minnesota, Wisconsin, Arizona).
Frequently Asked Questions
What is clinical trial NCT06386315 about?
NCT06386315 is a clinical study titled "Reduced Dose Radiotherapy for the Treatment of Indolent Non-Hodgkin Lymphoma". 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 sh...
What is the current status of trial NCT06386315?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 112 participants. The study started on 2024-05-15. Estimated completion is 2026-05-30.
What conditions does trial NCT06386315 study?
This clinical trial studies the following conditions: Indolent B-Cell Non-Hodgkin Lymphoma, Recurrent Indolent Non-Hodgkin Lymphoma, Recurrent Indolent B-Cell Non-Hodgkin Lymphoma, Refractory Indolent B-Cell Non-Hodgkin Lymphoma, Refractory Indolent Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT06386315?
The interventions under investigation include: Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Endoscopic Procedure (PROCEDURE), Involved-site Radiation Therapy (3 Fractions) (RADIATION), Involved-site Radiation Therapy (12 Fractions) (RADIATION).
Who is sponsoring clinical trial NCT06386315?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06386315 being conducted?
This trial has 7 study locations across Arizona, Florida, Minnesota, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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