chronic GVHD chronic GVHD
Conditions
Sponsors
Hashimoto Daigo
Eligibility
Inclusion criteria
Inclusion criteria: Patients with chronic GVHD who are receiving outpatient care or hospitalized at Hokkaido University Hospital or Sapporo hokuyu Hospital between the date of implementation approval and January 31, 2028
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be excluded from the study: Patients with a history of progressive brain lesions. Patients concurrently receiving Vagus Nerve Stimulation (VNS) therapy. Patients with a history of severe cardiovascular disease. Patients with a history of hypersensitivity to glycerin. Patients with a confirmed recurrence of a malignant tumor. Patients who are pregnant or breastfeeding. Patients with difficulty in oral intake. Patients with a history of dermatological reactions to metals or other substances. Patients with an implanted cardiac pacemaker or an implantable cardioverter-defibrillator (ICD). Any other patients deemed unsuitable for the study by the Principal Investigator or Sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) of chronic GVHD at Week 28 based on NIH Consensus Criteria following low-frequency therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events associated with low-frequency therapy. Change in forced expiratory volume in 1 second (FEV1) on pulmonary function tests from baseline to Week 28. Best Overall Response (BOR) rate observed from baseline to Week 28. Change in the Lee Symptom Scale score from baseline to Week 28. Changes in the dosage and types of concomitant medications for chronic GVHD from baseline to Week 28. Failure-Free Survival (FFS) from baseline to Week 28. (Failure is defined as death, progression of chronic GVHD based on NIH Consensus Criteria, initiation of new systemic therapy for chronic GVHD, or increase in the dosage or types of concomitant medications for chronic GVHD.) Association between pathophysiology and the localization of immune cells, expression positivity/intensity of inflammation-induced molecules, and presence of disease-related gene variants before and after low-frequency therapy; and correlations between inflammatory status, clinicopathological factors, and expression status of other analyzed molecules. | — |
Contacts
Public ContactDaigo Hashimoto
Hookaido university hospital
Outcome results
None listed