ClinicalTrials.gov
ClinicalTrials.gov Menu

Immune Monitoring After Allogeneic Hematopoietic Stem Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03233659
Recruitment Status : Recruiting
First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Mario Arpinati, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

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.


Condition or disease
Allogeneic Stem Cell Transplantation GVHD

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Function of Immune System in Patients Undergoing Allogeneic Stem Cell Transplantation
Actual Study Start Date : August 12, 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Group/Cohort
BMT patients
All patients undergoing Allogeneic Stem Cell Transplantation are enrolled in the study.



Primary Outcome Measures :
  1. The primary endpoint of study is detection of circulating cells by flow cytometry before and after Allogeneic Stem Cell Transplantation [ Time Frame: Patient's PB samples are harvested : on entering the department;1 month after transplantation ; 3, 6, 9,12 months after 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.


Biospecimen Retention:   Samples With DNA
Samples of serum and PBMC


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing Allogeneic Stem Cell Transplantation are enrolled in the study.
Criteria

Inclusion Criteria:

All patients undergoing Allogeneic hemapoietic Stem Cell Transplantation


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233659


Contacts
Contact: Mario Arpinati, MD +39 051 214 3799 mario.arpinati@unibo.it
Contact: Francesca Ulbar francesca.ulbar@aosp.bo.it

Locations
Italy
Mario Arpinati Recruiting
Bologna, Italy
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Investigators
Principal Investigator: Mario Arpinati, MD St. Orsola-Malpighi University Hospital Bologna, Italy

Publications:
Responsible Party: Mario Arpinati, MD, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT03233659     History of Changes
Other Study ID Numbers: IMM-2011-01
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mario Arpinati, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
Allogeneic Stem Cell Transplantation, APCs, GVHD