Clinical Implications of HMGB1 in Patients Treated With Chemotherapy or

Status Recruiting

Clinical Trial Summary

Acute Graft-versus-host disease(aGVDH) after allogeneic hematopoietic stem cell transplantation is one of the meaningful issues in aspect of patient's recovery and survival. in recent years, the understanding of the pathology of GVHD is much important to prevent or treat aGVHD. additionally, (oral) mucositis is one of the problems in patients with high dose chemotherapy, and mucositis by high-dose chemotherapy is related to HMGB-1 as proinflamtory cytokines. HMGB1 is a nuclear protein acts as a transcription factor, but, if it was released to the outside of cells by damaged cell or necrotic tissues, it works as cytokines for promoter of inflammation and cancers. at this point, there are no reported articles about correlation of HMGB1 and aGVHD in human. recently, we have seen excessive secretion of serum HMGB1 in mouse model, then base on this results, we will check correlation of HMGB1 and aGVHD/ oral mucositis in human.

Clinical Trial Description

1. materials 1) inclusion criteria

1. over 18-year-old

2. patients with myeloablative conditioning regimen

3. autologous transplant

4. patients with confirmation of acute GVHD as over grade II

5. patients with salvage chemotherapy

2) exclusion criteria

1. old age ( over 60-year-old)

2. patients with reduced intensity stem cell transplantation

2. method 1) check the serum level of HMGB1, TNF-a, IL-1b, IL-6, Th1, Th2, Th17, FoxP3 on 7-day before transplant day(D-7), transplant day(D0), 7-day after transplant(D+7), D+14, D+21. 2) check the immunohistochemistry level of tissue in diagnosed aGVHD ( performed sigmoidoscopy and random biopsy of gut is routine process in our center) 3) check the oral mucositis grades (using WHO grading system, NCI -CTC ver.3 scoring system)

3. analysis 1) student t-test , chi-square test 2) survival analysis ;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02044185
Study type	Observational
Source	Seoul St. Mary's Hospital
Contact	young-woo JEON, bachelor, MD
Phone	821042324067
Status	Recruiting
Phase	N/A
Start date	January 2014
Completion date	December 2015

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02241018` - MSCs Combined With CD25 Monoclonal Antibody and Calcineurin Inhibitors for Treatment of Steroid-resistant aGVHD	Phase 2/Phase 3
Completed	`NCT04539470` - Study to Evaluate the Safety and Pharmacokinetics of Efmarodocokin Alfa in Combination With Standard of Care in Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation	Phase 1
Terminated	`NCT02245412` - A Phase 2A Study of ALXN1007 in Participants With Newly Diagnosed Acute Lower Gastrointestinal Graft-Versus-Host Disease	Phase 2
Recruiting	`NCT02659657` - Prophylaxis Roles of IL-2 Treatment on GVHD After Transplantation	Phase 2
Completed	`NCT03497273` - Safety of Itacitinib in Combination With Corticosteroids for Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese Subjects	Phase 1
Completed	`NCT05825833` - Infliximab Efficacy in Relation to Therapeutic Drug Monitoring and Serum TNFα Levels in Pediatric HSCT
Not yet recruiting	`NCT06294678` - Effect of Stem Cell Infusion Time on aGVHD in Patients With Hematological Malignancies	Phase 3
Not yet recruiting	`NCT06294691` - Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases	Phase 3
Recruiting	`NCT04285424` - FMT for Steroid Resistant Gut Acute GVHD	Early Phase 1
Terminated	`NCT01903473` - Donor Regulatory T Cells Infusion in Patients With Chronic Graft-versus-host Disease (GVHD)	Phase 2
Recruiting	`NCT01765634` - Mesenchymal Stem Cells for Treatment of Refractory Acute Graft-versus-host Disease	Phase 2
Terminated	`NCT00282503` - Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Acute Graft Versus-Host Disease	Phase 3
Recruiting	`NCT01521039` - Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease
Terminated	`NCT03721965` - Safety and Efficacy of Itacitinib in Combination With Corticosteroids for Treatment of Graft-Versus-Host Disease in Pediatric Subjects	Phase 1/Phase 2
Not yet recruiting	`NCT04971551` - A Study of Jaktinib for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.	Phase 2
Completed	`NCT02743351` - Study of ProTmune for Allogeneic HCT in Adult Patients With Hematologic Malignancies	Phase 1/Phase 2
Terminated	`NCT05673876` - A Study to Assess the Safety and Pharmacokinetics of GDC-8264 in Combination With Standard of Care in Participants With Acute Graft-Versus-Host Disease (aGVHD)	Phase 1
Recruiting	`NCT02611180` - Dendritic Cells in Patients With Acute or Chronic Skin Graft Versus Host Disease

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Implications of HMGB1 in Patients Treated With Chemotherapy or Hematopoietic Stem Cell Transplantation — CHIP-SCT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms