Survival and incidence of GVHD in children receiving T globulin 25 as an immunosuppressant during hematopoietic stem cell transplantatio

Phase 3

Recruiting

• Conditions: Condition 1: hematopoietic stem cell transplantation. Condition 2: Graft Versus Host Disease. Condition 3: Graft Versus Host Disease.; Stem cells transplant status; Acute graft-versus-host disease; Chronic graft-versus-host disease; Z94.84; D89.810; D89.811

• Registration Number: IRCT20210523051368N1
• Lead Sponsor: Kowsar Biotechnology company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 8 March 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1 to 18 year-old hematopoietic stem cell transplant recipients with anti-thymocyte globulin in their conditioning regimen
parents or legally acceptable representatives must have provided a written informed consent
Lansky score above 70%
Absence of severe active infection
use of bone marrow or G-CSF-stimulated peripheral blood stem cells

Exclusion Criteria

History of previous stem cell transplantation (re-transplantation)
use of umbilical cord blood stem cells
history of previous treatment with anti-thymocyte globulin in the last three months
Known allergic reaction to rabbit proteins
abnormal liver function (total bilirubin greater than three times the upper limit of normal (ULN), conjugated bilirubin> 2 mg/dl, transaminases greater than three times the ULN)
abnormal renal function adjusted for the patient's age
abnormal heart function (left ventricular ejection fraction < 50% after ECHO, congestive heart failure, arrhythmia)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of acute GVHD. Timepoint: First 100 days after transplantation. Method of measurement: Physical examination and laboratory findings.;Overall survival. Timepoint: until 1 year after transplantation. Method of measurement: Mortality assessment.

Secondary Outcome Measures

Name	Time	Method
Rate of chronic GVHD. Timepoint: From 100 days until 1 year after transplantation. Method of measurement: Physical examination and laboratory findings.;Rate of bacterial infections. Timepoint: until 1 year after transplantation. Method of measurement: Blood culture.;Rate of fungal infections. Timepoint: until 1 year after transplantation. Method of measurement: Laboratory test (Aspergillus galactomannan antigen in blood by ELISA).;Rate of viral infections. Timepoint: until 1 year after transplantation. Method of measurement: Laboratory test (RT-PCR for CMV infection).;Rejection. Timepoint: Until 1 month after transplantation. Method of measurement: evaluation of chimerism by Short tandem repeat or FISH.