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

Seoul St. Mary's Hospital

Status: Unknown

Conditions: Acute Graft-versus-host Disease

Treatments: Drug: salvage chemotherapy, total body irradiation

Study type: Observational

Funder types: Other

Identifiers

NCT02044185

CMC-SGC-Lymphoma-LAB-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

100 participants in 2 patient groups

high dose chemotherapy

Description:

group of using myeloablation regimen, autologous stell cell transplantation

Treatment:

Drug: salvage chemotherapy, total body irradiation

control group

Description:

normal population with health screening

Treatment:

Drug: salvage chemotherapy, total body irradiation