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

IRCCS Burlo Garofolo

Status: Completed

Conditions: Hematopoietic Stem Cell Transplantation

Treatments: Other: Higher lymphocyte/ATG ratio; Other: Lower lymphocyte/ATG ratio

Study type: Observational

Funder types: Other

Identifiers

NCT04869254

RC 08/2019

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 1 day to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age of the patients between 0 and 17
2. Diagnosis of hematological or oncological disease undergoing allogeneic bone marrow transplantation
3. Patients undergoing myeloablative conditioning
4. Patients that received ATG as GVHD prophylaxis
5. Patients whose consent has already been acquired for the processing of data for research purposes
6. Minimum follow-up of 12 months

Exclusion criteria

1. Bacterial and / or fungal infection present at the time of bone marrow transplantation
2. Use of Thymoglobulin in the 3 months prior to transplantation
3. Allergy and / or intolerance to the active substances or excipients contained in Thymoglobulin

Trial design

102 participants in 1 patient group

Hematopoietic stem cells transplantation

Description:

patients undergone allogeneic or autologous bone marrow transplant who received immunomodulatory therapy with Thymoglobulin

Treatment:

Other: Lower lymphocyte/ATG ratio

Other: Higher lymphocyte/ATG ratio