Clinical trial · Interventional
Electron Beam Radiotherapy for the Treatment of Refractory Sclerodermatous Chronic Graft Versus Host Disease
Pilot Study of Safety and Feasibility of Electron Beam Radiotherapy to Treat Refractory Sclerodermatous Chronic Graft-versus-Host Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic and Lymphoid System Neoplasm | Hematopoietic and Lymphatic System Neoplasm | ALIAS | 0.90 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Refractory Sclerodermatous Graft Versus Host Disease | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Electron Beam Therapy | Combination Product | — | UNRESOLVED |
| High Frequency Ultrasound Imaging | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Radiation Therapy Treatment Planning and Simulation | Radiation | — | UNRESOLVED |
| Skin Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (electron beam radiotherapy)
- description
- Patients undergo radiotherapy simulation on day -14 using either a clinical setup or CT simulation at the discretion of the treating radiation oncologist. Patients then undergo electron beam radiotherapy on day 0. Patients also undergo skin biopsies at baseline, day 28, and day 168 after radiotherapy, and high frequency ultrasound (HFUS) scans on days 28, 56, 84, 112, 140, and 168 after radiotherapy.
- interventionNames
- Procedure: Biospecimen Collection
- Procedure: Computed Tomography
- Combination Product: Electron Beam Therapy
- Procedure: High Frequency Ultrasound Imaging
- Other: Questionnaire Administration
- Radiation: Radiation Therapy Treatment Planning and Simulation
- Procedure: Skin Biopsy
Primary outcomes (1)
- measure
- Incidence of toxicity
- timeFrame
- From study initiation of study treatment to day 28
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Agreement to allow the use of archival tissue from diagnostic tumor biopsies * If unavailable, exceptions may be granted with study principal investigator (PI) approval * Permitting to perform clinical photography * Age: \>= 18 years * Histologically confirmed sclerodermatous GHVD * Relapsed/refractory sclerodermatous cGVHD * Measurable disease of at least 2.0 cm * Failed at least \>= 2 prior frontline therapies for sclerodermatous chronic GvHD * Fully recovered from the acute toxic effects (except alopecia) to =\< Grade 1 to prior therapy * Women of childbearing potential (WOCBP): negative urine or serum pregnancy test If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * To be performed within 7 days prior to Day 1 of protocol therapy unless otherwise stated * Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 1 month after the last dose of protocol therapy * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only) Exclusion Criteria: * Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to Day 1 of protocol therapy * Herbal medications * Females only: Pregnant or breastfeeding * Inability to comprehend and sign inform consent * Individuals known to carry germline gene mutations in TP53, NBS and ATM. * Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
References
Publications (0)
Data not yet available