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Electron Beam Radiotherapy for the Treatment of Refractory Sclerodermatous Chronic Graft Versus Host Disease

NCT05515692 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2024-07-23

No results posted yet for this study

Summary

This clinical trial tests the safety and side effects of a single small dose (fraction) of electron beam radiotherapy (e-BRT) at 10 Gy dose in treating patients with refractory (did not respond to other treatments) sclerodermatous chronic graft versus host disease (GVHD). GVHD is the most common complication after bone marrow transplant from a donor and happens as a result of donor immune cells attacking patients cells. Fibroblasts are skin cells that produce collagen and fibers and are the cells mainly involved in development of skin GVHD. Previous research has shown that fibroblasts can become fibrocytes (inactive fibroblast) at the fastest rate after receiving 8 Gy or more radiation. Moreover, regulatory T cells (Tregs) are cells from the immune system that can control GVHD and previous research has shown that radiation can increase the number of Tregs. Therefore, e-BRT at 10 Gy has the potential to improve GVHD by increasing the fibroblast to fibrocyte speed and the number of Tregs.

Conditions

  • Hematopoietic and Lymphoid System Neoplasm
  • Malignant Solid Neoplasm
  • Refractory Sclerodermatous Graft Versus Host Disease

Interventions

PROCEDURE

Biospecimen Collection

Correlative studies

PROCEDURE

Computed Tomography

Undergo radiotherapy simulation using CT

COMBINATION_PRODUCT

Electron Beam Therapy

Undergo electron beam radiotherapy

PROCEDURE

High Frequency Ultrasound Imaging

Undergo HFUS

OTHER

Questionnaire Administration

Ancillary studies

RADIATION

Radiation Therapy Treatment Planning and Simulation

Undergo radiotherapy simulation using clinical setup

PROCEDURE

Skin Biopsy

Undergo biopsy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Karamjeet S Sandhu · City of Hope Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2024-09-18
Completion
2024-09-18
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05515692 on ClinicalTrials.gov