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• W2045207966 abstract "Sequential pilot studies at City of Hope using CSA/MMF based prophylaxis in the URD reduced intensity setting have shown high rates of acute GVHD (grade 3-4, 40%; lethal 27%, Rodriguez et al., Bone Marrow Transplant, 2004) that are similar to historical controls using CSA or tacrolimus + MTX. Emerging data suggest a lower incidence of GVHD with Thymoglobulin. We are therefore conducting a prospective study adding Thymoglobulin to CSA/MMF for URD HCT using flu/mel; preliminary results are reported. The GVHD prophylaxis consists of CSA 3 mg/kg/d (beginning day −1), MMF 15 mg/kg 3×/d (beginning day 0), and Thymoglobulin 7.5 mg/kg total dose (day −4 to day −1/0). Fifteen patients (pts) have been enrolled, 2 discontinued Thymoglobulin due to infusional toxicities, and 11 are evaluable for acute GVHD. The median age is 50 years (33-63), 10 male, 3 female. Diagnoses include: myelofibrosis (4), B-cell NHL (4), AML (2), Hodgkin (1), myeloma (1), bone marrow failure (1). Stem cell source was all PB; median CD34 cell dose of 7.19 × 106/kg (range 4-19 × 10 6). Donor/recipients were HLA allele matched except for 3 pairs with allele mismatch at class I, and one at both class I and DRB1. Manageable infusional toxicities with Thymoglobulin were seen in 11 patients. Durable neutrophil engraftment was seen in all pts with a median time to ANC >500 of 14 days (range 11-22). Day 30 STR analysis in bone marrow MNC was 100% donor in all but 1 pt (94%). With a median follow-up of 6 months (range 1-14 months), 12/13 pts are alive; 1 pt died of diffuse alveolar hemorrhage; 1 pt with diffuse large cell NHL has relapsed, others are in remission. Acute GVHD grade 4, 3 and 2 was seen in 1/11 (9%), 1/11 (9%), and 5/11 (45%) pts, respectively; the only pt with grade 4 GVHD inadvertently received a CD34 cell dose of 19 × 106/kg. All pts responded to treatment. Chronic GVHD has not been observed in any of these pts. EBV reactivation was seen in 3 pts, and all responded to a single infusion of rituximab. CMV reactivation was seen in 2 pts, including one with CMV pneumonia; another had CMV colitis without blood reactivation. No other opportunistic infections have been observed. These preliminary results suggest that Thymoglobulin as given in this protocol is safe but infusional toxicities are common. The incidence of severe acute GVHD appears lower than historical controls; 100-day TRM, chronic GVHD and relapse rates are presently very low; EBV reactivation is manageable and CMV disease has been observed." @default.
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• W2045207966 date "2006-02-01" @default.
• W2045207966 modified "2023-09-23" @default.
• W2045207966 title "A prospective pilot study of thymoglobulin, cyclosporine (CSA) and MMF as GVHD prophylaxis in unrelated donor (URD) HCT using fludarabine and melphalan (flu/mel) for high-risk patients with hematological malignancies" @default.
• W2045207966 doi "https://doi.org/10.1016/j.bbmt.2005.11.192" @default.
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