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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02044185
Other study ID # CMC-SGC-Lymphoma-LAB-01
Secondary ID
Status Recruiting
Phase N/A
First received January 21, 2014
Last updated April 21, 2015
Start date January 2014
Est. completion date December 2015

Study information

Verified date April 2015
Source Seoul St. Mary's Hospital
Contact young-woo JEON, bachelor, MD
Phone 821042324067
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
salvage chemotherapy, total body irradiation
there are no direct interventions to our patients.

Locations

Country Name City State
Korea, Republic of Seoul St.Mary's hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

Brennan TV, Lin L, Huang X, Cardona DM, Li Z, Dredge K, Chao NJ, Yang Y. Heparan sulfate, an endogenous TLR4 agonist, promotes acute GVHD after allogeneic stem cell transplantation. Blood. 2012 Oct 4;120(14):2899-908. doi: 10.1182/blood-2011-07-368720. Epub 2012 Jul 3. — View Citation

Jube S, Rivera ZS, Bianchi ME, Powers A, Wang E, Pagano I, Pass HI, Gaudino G, Carbone M, Yang H. Cancer cell secretion of the DAMP protein HMGB1 supports progression in malignant mesothelioma. Cancer Res. 2012 Jul 1;72(13):3290-301. doi: 10.1158/0008-5472.CAN-11-3481. Epub 2012 May 2. — View Citation

Kang R, Zhang Q, Zeh HJ 3rd, Lotze MT, Tang D. HMGB1 in cancer: good, bad, or both? Clin Cancer Res. 2013 Aug 1;19(15):4046-57. doi: 10.1158/1078-0432.CCR-13-0495. Epub 2013 May 30. Review. — View Citation

Kornblit B, Masmas T, Petersen SL, Madsen HO, Heilmann C, Schejbel L, Sengeløv H, Müller K, Garred P, Vindeløv L. Association of HMGB1 polymorphisms with outcome after allogeneic hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2010 Feb;16(2):239-52. doi: 10.1016/j.bbmt.2009.10.002. Epub 2009 Oct 9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other tissue IHC stain level of biopsy samples of diagnosed acute GVHD if patients diagnosed with acute GVHD will be performed random biopy of colon or stomach. Yes
Other oral mucositis find-out the correlation HMGB1 level and oral mucositis grading 1 month Yes
Primary comparison of serum HMGB1 level before and after diagnosed acute GVHD day 7 before stem cell transplantation(SCT), day 0, day 7, 14 after SCT, and date of diagnosed acute GVHD in all patients. 6 months Yes
Secondary serum level of immunosuppressive drugs in patients with acute GVHD day 7 before stem cell transplantation(SCT), day 0, day 7, 14 after SCT, and date of diagnosed acute GVHD in all patients. 3 months No
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