AML-184: Administration of Cyclophosphamide for GVHD Prophylaxis After Stem Cell Transplantation From Unrelated Donors And Infections: A Multi-Center Experience

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      There is still no clear information about the incidence and consequences of infections with cyclophosphamide (PTCy) administration as prophylaxis against graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT).


      Revealing the incidence of pre-vaccination bacterial and viral infections (cytomegalovirus [CMV], herpes virus, and BK-polyomavirus hemorrhagic-cystitis), infection-related mortality, and predictive factors associated with PTCy application after allo-HSCT was the study aim.


      Patients who underwent allo-HSCT from 9/10–10/10 HLA tissue-matched, unrelated donors and received cyclophosphamide for post-transplant GVHD prophylaxis from 3 centers between 2015 and 2020 were retrospectively reviewed. Infections that developed in the first 100 days after transplantation were recorded.


      Forty-one patients, M/F: 25/16, were included in the study. The mean age was 40.8 years (21–67), with 23 AML, 11 ALL, 3 NHL, 2 MDS, one biphenotypic leukemia, and 1 HL diagnosis. HLA tissue compatibility was 9/10 in 32 patients and 10/10 in 9 patients. All patients received one myeloablative priming regimen [TBI (800–1200 cGy)+Flu (30 mg/m2×5), Cy (60 mg/kg×2) + TBI (1200 cGy), treosulfan (10 g/m2×3) + Flu (40 mg/m2×4)]. In GVHD prophylaxis, PTCy was administered 72 and 96 hours following transplantation in combination with calcineurin inhibitors ± methotrexate ± mycophenolate mofetil. Levofloxacin, valacyclovir, fluconazole, and trimethoprim-sulfamethoxazole were empirically given to all patients along with the transplant preparation regimen.


      At least one episode of febrile neutropenia (FEN) developed in all patients during the transplantation process. More than one episode of FEN developed in 22% of the patients. One patient died due to septic shock on post-transplant day 9. The incidence of CMV infection requiring treatment was 36.6% in the first 100 days and 41.5% at 1 year. All patients except 1 were CMV IgG-positive before transplantation. CMV reactivation was observed in 50% (15/15) of donor/patient CMV IgG (+/+). CMV reactivation was found in 30% (3/7) of the donor/patient CMVIgG (–/+) patients. Only one of these patients received antiviral therapy due to multiple reactivations. In 4 patients, CMV pneumonia developed, and 3 of them died. The rate of polyomavirus-associated cystitis was 7.3% (3/41). In the first year after transplantation, invasive fungal infection occurred in only 4 patients (9.8%), herpes virus infection occurred in 1 patient. Three patients received tenofovir–entecavir treatment because of anti-HBcIg positivity, and HBV reactivation was not detected in any of the patients.


      GVHD prophylaxis containing PTCy after allo-HSCT from an unrelated donor does not have an increased risk in terms of bacterial, viral, or fungal infections and can be used safely.


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