Real-world safety and effectiveness of alemtuzumab as a conditioning regimen for hematopoietic stem cell transplantation.

ABSTRACT: Alemtuzumab, a humanized monoclonal antibody directed against CD52, is indicated for administration prior to allogeneic hematopoietic stem cell transplantation (HSCT) in Japan. This post-marketing surveillance study was conducted as part of a risk management plan to confirm the safety and effectiveness of alemtuzumab in clinical practice, as mandated by the Japanese health authorities. Fifty-nine patients aged 0 to 69 years received alemtuzumab prior to HSCT for hematologic malignancies (n = 22), aplastic anemia (n = 7), or other diseases (n = 30). The number of mismatched human leukocyte antigens between donor and recipient was ≥ 2 in 39 patients (66.1%), 1 in seven patients (11.9%) and 0 in 11 patients (18.6%). Overall, 38 of 59 patients (64.4%) developed an adverse drug reaction (ADR),

SUBMITTER: Sasakura Y 

PROVIDER: S-EPMC12572087 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature