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Polyclonal anti‐T‐cell globulin as part of the preparative regimen for pediatric allogeneic stem‐cell transplantation

Abstract: To prevent graft rejection and graft‐versus‐host disease (GvHD) after allogeneic stem‐cell transplantation (ASCT), 56 children were given polyclonal anti‐T‐cell globulin (ATG) as part of the conditioning regimen. Of the 56 children in the cohort, 27 had a non‐malignant disease and 29 had different hematological malignancies. Eight were in first remission of leukemia and the remainder in later stages. Donors were in 16 cases a human leucocyte antigen (HLA)‐identical sibling and in 40 a matched unrelated donor (MUD). The control group comprised 16 patients with an HLA‐identical donor; the children in this group were not treated with ATG. Side‐effects related to the ATG treatment occured in 63% of the patients and included fever, chills, headache, dyspnoea, nausea/vomiting, body pain, fall in blood pressure, and transient respiratory arrest. Engraftment occured in 55 (98%) of the ATG‐treated patients at a median of 17 (11–27) days after ASCT. One rejection occured at 23 days post‐SCT. The probabilities of acute graft‐versus‐host disease (GvHD) of grades II–IV were 6% for patients with an HLA‐identical donor, 12% for controls, and 26% for the MUD group. Chronic GvHD occured in 20%, 50%, and 50% of patients in the three groups, respectively. Transplant‐related mortality rates at 100 days were 6%, 6%, and 7%, respectively. The 5‐yr survival rate was 94% and 81% using sibling donors, with and without ATG respectively, and 53% using unrelated donors (p = 0.002). Disregarding donor type, among the ATG‐treated patients 5‐yr survival rates were 46% in patients with a malignant disease and 77% in non‐malignant disorders. Relapse and relapse‐free survival rates were 42% and 46%, respectively. Five out of 12 patients who showed an early full donor chimerism in the T‐cell lineage developed acute GvHD of grades II–IV, compared to none out of 13 patients being mixed chimeras (p = 0.01). Hence, the use of polyclonal ATG as part of conditioning prior to ASCT in children is safe and the survival rate encouraging.