NCT04869254

Lymphocyte Count, ATG Dose and Incidence and Severity of GVHD in Pediatric Recipients of HSCT

Completed Last updated 3 May 2021

What this trial tests

trial testing Lower lymphocyte/ATG ratio in Hematopoietic Stem Cell Transplantation in 102 participants. Completed in 31 December 2020.

Timeline

1 January 2000

Primary endpoint
31 December 2018

31 December 2020

Quick facts

Lead sponsor	IRCCS Burlo Garofolo
Status	Completed
Study type	OBSERVATIONAL
Enrollment	102
Start date	1 January 2000
Primary completion	31 December 2018
Estimated completion	31 December 2020
Sites	1 location across Italy

Drugs / interventions tested

• Lower lymphocyte/ATG ratio
• Higher lymphocyte/ATG ratio

Conditions studied

• Hematopoietic Stem Cell Transplantation — all drugs for Hematopoietic Stem Cell Transplantation →

Sponsor

IRCCS Burlo Garofolo — full company profile →

Who can join

Adults 1 Day to 17, any sex, with Hematopoietic Stem Cell Transplantation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Despite increasing success rate in hematopoietic stem cell transplantation (HSCT) control of graft versus host disease (GVHD) remains a significative burden in mortality and morbidity. A lot of strategies could lower the incidence and gravity of the disease and immunosuppressive treatment as GVHD prophylaxis still represent the main method.

Although immunosuppressive treatment showed a good effect on GVHD mortality a lot of studies also highlight an increase of relapse and infection related mortality that jeopardize the effect on overall survival of HSCT recipient. Using anti thymocyte globulin (ATG) as GVHD prophylaxis shares the same double-edge effect as other immunosuppressive treatment although is still unclear how manage dose and timing of the infusion to minimize promoting effect on infections and maximize protective effect on GVHD. Biological effect of ATG lead to a dose- related delay in all class of T-cell reconstitution but our data are mostly from adult studies with high doses between 30 and 60 mg/kg due to the more important burden of GVHD in HSCT adult population. As for other treatment in HSCT conditioning we would like to study a personalized approach for ATG treatment: some studies focus on tuning of ATG dose for kilos but previous evidence showed that the same dose could made too little or too much immunosuppressive effect for different patients, even though same age and same stem cell source.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pre-Transplant Total Lymphocyte Count Determines Anti-Thymocyte Globulin Exposure, Modifying Graft-versus-Host Disease Incidence and Post-Transplant Thymic Restoration: A Single-Center Retrospective Study.
   Grasso AG, Simeone R, Maestro A, Zanon D, et al · · 2023 · cited 5× · PMID 36675660 · DOI 10.3390/jcm12020730