Clinical Implications of HMGB1 in Patients Treated With Chemotherapy or Hematopoietic Stem Cell Transplantation

• Conditions: Acute Graft-versus-host Disease
• Interventions: Drug: salvage chemotherapy, total body irradiation

• Registration Number: NCT02044185
• Lead Sponsor: Seoul St. Mary's Hospital

Brief 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.

Detailed 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

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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 Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-22
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Exclusion Criteria

1. very old age ( over 75-year-old) 2. patients with reduced intensity stem cell transplantation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
high dose chemotherapy	salvage chemotherapy, total body irradiation	group of using myeloablation regimen, autologous stell cell transplantation
control group	salvage chemotherapy, total body irradiation	normal population with health screening

Primary Outcome Measures

Name	Time	Method
comparison of serum HMGB1 level before and after diagnosed acute GVHD	6 months	day 7 before stem cell transplantation(SCT), day 0, day 7, 14 after SCT, and date of diagnosed acute GVHD in all patients.

Secondary Outcome Measures

Name	Time	Method
serum level of immunosuppressive drugs in patients with acute GVHD	3 months	day 7 before stem cell transplantation(SCT), day 0, day 7, 14 after SCT, and date of diagnosed acute GVHD in all patients.

Trial Locations

Locations (1)

Seoul St.Mary's hospital; 🇰🇷 Seoul, Korea, Republic of