Work

A phase II randomized open-label study anti-CMV hyperimmune globulin vs standard IGIV for prevention of cytomegalovirus (CMV) reactivation in hypogammaglobulinemic adult allogeneic hematopoietic stem cell transplants (AHSCT)

Year: 2006

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: Immune globulin is frequently given in the post-transplant phase of allogeneic HSCT as part of pre-emptive anti-CMV therapy. The goal of therapy is to reduce the incidence of CMV reactivation and the subsequent sequelae of CMV disease, to minimize GVHD, and to limit bacterial infections. Previous IGG replacement strategies provided scheduled IGIV replacement empirically, without regard for physiologic hypogammaglobulinemia. The primary aim of this study was to examine whether anti-CMV hyperimmune globulin (Cytogam®) versus standard IGIV reduced the incidence of CMV activation in hypogammaglobulinemic patients. Ablative or nonmyeloablative, CMV+, AHSCT patients were monitored biweekly for IGG levels and received 200 mg/kg QOW of their designated agent if their IGG was < 400 mg/dl during the first 120 days after HSCT. Weekly CMV screening was performed. Antiviral therapy was begun for evidence of molecular reactivation. A quantitative PCR based assay was used in the majority of patients and 2 consecutive values <400 copies or 1 value >400 copies resulted in initiation of antiviral therapy. Ninety patients were enrolled at OHSU between 09/00 and 07/04. Forty-six were randomized to IGIV and 44 to Cytogam®. Three patients randomized to Cytogam® received 1 dose of IGIV and 4 patients received additional IGIV for therapeutic reasons: ITP(1), CMV infection (2), parvovirus (1). Groups were demographically similar for age, gender, and transplant type (URD vs sib). Sixty-two of 90 (69%) patients completed 120 days, 29 (32%) have completed 2 years of follow-up, and 8 are still being actively followed. Forty-two of 90 patients never had an IGG < 400 and received no study drug. Twenty Cytogam® and 28 IVIG patients received study drug by 2 years. Eighteen of 21 patients receiving IVIG and 9/16 patients receiving Cytogam® had CMV activation in the first 120 days (P < .05) (Table1). There were 2 cases of CMV disease: IGIV-colitis [survived], Cytogam®-pneumonia [perished]). There were no deaths attributed to either drug and a single related adverse event was recorded, rigors related to the too rapid infusion of Cytogam®. Of the 28 early deaths on this study, 10 were from infections, 3 graft failure, 5 pulmonary, 4 recurrence, 3 GVHD, 1 MOF, and 1 other. In this small study of hypogammaglobulinemic AHSCT patients, IGG replacement with Cytogam® was associated with decreased rates of CMV activation in the first 120 days.Table 1Overall ResultsDrug/CMV Status (all patients)Cytogam R N = 41IGIV N = 49No drug/no CMV1010No drug/CMV Activation1111Drug/no CMV118Drug/CMV activation920 Open table in a new tab

Source: Transplantation and Cellular Therapy

DOI: 10.1016/j.bbmt.2005.12.015