Study design/protocol
comorbidity, MM, toxicity, SIB, AML, MPS, ALL, Non-Hodgkin-lymphoma, COPD, NHL
MULTIPLE MYELOMA, ACUTE MYELOID LEUKEMIA, MYELODYSPLASTIC SYNDROME, AML, ACUTE LYMPHOBLASTIC LEUKEMIA, COPD, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, MYELOPROLIFERATIVE SYNDROME, NHL, ONCOLOGY, TRANSFUSION REACTION
This controlled, randomized, open label, multicenter phase I/IIa trial exploring the safety and efficacy of allogeneic donor-derived peptide-stimulated T cells with specificity for CMV and EBV in a preventative/pre-emptive setting in patients after aSCT was approved by the federal authority Paul Ehrlich Institute (No. 2016/01) and by the Institutional Review Board of the University Hospital Erlangen (306_13 Az). It was conducted in accordance with the ethical principles of the Declaration of Helsinki (ClinicalTrials.gov Identifier: NCT02227641). All patients and donors provided written informed consent.The major goal of this study was to assess feasibility of manufacturing and safety of the T cell product. The primary endpoint was acute transfusion reaction and acute GvHD as a potential late toxicity of the product due to the transfer of activated T cells acute GvHD. The design of the study is shown in detail in Enrollment and randomization were performed within 28 days prior to stem cell transplantation. Details of the patient population enrolled in this study are shown in Summary of patient characteristics.There was no statistically significant difference with regard to major factors influencing outcome between the groups. Only patients with 10/10 HLA match were included into the study. ALL, acute lymphoblastic leukemia; AML, acute myeloid leukemia; MDS, myelodysplastic syndrome; NHL, Non-Hodgkin-lymphoma; MM, multiple myeloma; MPS, myeloproliferative syndrome; SIB, sibling donor; MUD, matched unrelated donor; BSA, body surface area; BMI, body mass index; ECOG, Eastern Cooperative Oncology Group performance score; HSCT-CI, hematopoietic stem cell transplantation comorbidity index; COPD, chronic obstructive pulmonary disease. For test of significance Fisher-exact and Chi-Square test was used.The SAE-Management was independently performed by the Centre for Clinical Studies of the University of Erlangen using VigilanceOne™ database for safety data acquisition and reporting.