Immune Monitoring After Allogeneic Hematopoietic Stem Cell Transplantation

NCT03233659 | Completed DMC

• 1 other identifier: IMM-2011-01
• Study Type: observational
• Target: 177
• Locations: 1 country
• Sites: 1

Brief Summary

Graft versus Host disease ( GVHD) is one of the major complications of Allogeneic Stem Cell Transplantation. Acute GVHD develops early ( within 2to 3 months) after transplantation and is the leading cause of death of transplanted patients. The pathogenesis of Chronic GVHD is still little known. Chronic GVHD is caused by donor T lymphocytes, but we have no precise knowledge on the participation of specific subsets of immune system cells to chronic GVHD. In general, chronic GVHD is associated with an increase in the number of T effector lymphocytes, both helper type 2 and cytotoxic. Recently, also antigen presenting cells (APCs) have been implicated in pathogenesis of chronic GVHD in studies performed on animal models. T lymphocyte responses that characterize chronic GVHD require that recipient antigens are submitted by APCs which originate from the donor's HSC ( Hematopoietic Stem Cells) APCs are heterogeneous population that includes dendritic cells (DCs) ,monocytes, activated B lymphocytes and CD34+ cell subpopulations. These cells can be identified by cytometry. The data about APCs role in chronic GVHD are preliminary and often discordant. Seemingly, there isn't correlation between circulating APCs number and risk of cGVHD. However, recent data of our group show that patients with cGVHD could have higher number of monocytes in bone marrow than transplanted patients without cGVHD. The aim of study is to measure the number of circulating immune cells in the PB (peripherical blood) before and after Allogeneic Hematopoietic Stem Cell Transplantation by flow cytometry.

Conditions

Allogeneic Stem Cell Transplantation; GVHD

Keywords

Allogeneic Stem Cell Transplantation, APCs, GVHD

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of study is detection of circulating cells by flow cytometry before and after Allogeneic Stem Cell Transplantation

  We analyze the following cells:Myeloid Dendritic Cells, Plasmacytoid Dendritic cells, CD16+ Dendritic cells, CD14+ monocytes, CD14+/CD16+ monocytes, total T lymphocytes, total T helper lymphocytes, central memory, naive, effector memory and effector T helper lymphocytes, total cytotoxic lymphocytes, central memory, naive, effector memory and effector cytotoxic lymphocytes, CD16+/CD56+ NK cells, B lymphocytes, T regulatory lymphocytes.

  Patient's PB samples are harvested : on entering the department;1 month after transplantation ; 3, 6, 9,12 months after transplantation

Study Arms (1)

BMT patients

All patients undergoing Allogeneic Stem Cell Transplantation are enrolled in the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing Allogeneic Stem Cell Transplantation are enrolled in the study.

You may qualify if:

• All patients undergoing Allogeneic hemapoietic Stem Cell Transplantation

You may not qualify if:

• Patient not undergoing allogeneic hematopoietic stem cell transplantation

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Mario Arpinati

Bologna, Italy

Location

Related Publications (5)

• Nakamura K, Amakawa R, Takebayashi M, Son Y, Miyaji M, Tajima K, Nakai K, Ito T, Matsumoto N, Zen K, Kishimoto Y, Fukuhara S. IL-4-producing CD8(+) T cells may be an immunological hallmark of chronic GVHD. Bone Marrow Transplant. 2005 Oct;36(7):639-47. doi: 10.1038/sj.bmt.1705107.

  PMID: 16044136 BACKGROUND

• D' Asaro M, Salerno A, Dieli F, Caccamo N. Analysis of memory and effector CD8+ T cell subsets in chronic graft-versus-host disease. Int J Immunopathol Pharmacol. 2009 Jan-Mar;22(1):195-205. doi: 10.1177/039463200902200122.

  PMID: 19309567 BACKGROUND

• Arpinati M, Chirumbolo G, Saunthararajah Y, Stanzani M, Bonifazi F, Bandini G, Baccarani M, Rondelli D. Higher numbers of blood CD14+ cells before starting conditioning regimen correlate with greater risk of acute graft-versus-host disease in allogeneic stem cell transplantation from related donors. Biol Blood Marrow Transplant. 2007 Feb;13(2):228-34. doi: 10.1016/j.bbmt.2006.10.004.

  PMID: 17241928 BACKGROUND

• Anderson BE, McNiff JM, Jain D, Blazar BR, Shlomchik WD, Shlomchik MJ. Distinct roles for donor- and host-derived antigen-presenting cells and costimulatory molecules in murine chronic graft-versus-host disease: requirements depend on target organ. Blood. 2005 Mar 1;105(5):2227-34. doi: 10.1182/blood-2004-08-3032. Epub 2004 Nov 2.

  PMID: 15522961 BACKGROUND

• Arpinati M, Chirumbolo G, Marzocchi G, Baccarani M, Rondelli D. Increased donor CD86+CD14+ cells in the bone marrow and peripheral blood of patients with chronic graft-versus-host disease. Transplantation. 2008 Jun 27;85(12):1826-32. doi: 10.1097/TP.0b013e3181788a84.

  PMID: 18580477 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Samples of serum and PBMC

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Mario Arpinati, MD

  St. Orsola-Malpighi University Hospital Bologna, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: July 28, 2017
• Study Start: August 12, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

IT (1)