Allogenic hematopoietic cell transplant is a therapeutic procedure for patients suffering with hematopoietic malignancies. Many patients especially non-white do not get a matched donor in their family for transplant. In such cases, umbilical cord blood transplantation (UCBT) serves as a standard treatment procedure. However, evidence suggests that adult UCBT may be linked with transplant related mortality as well as morbidity, and delayed hematopoietic recovery. Researchers have recently reported the findings with efficacy of omidubicel in mitigating the issue related with UCBT in the scientific journal Blood.
A randomized phase 3 study enrolled 125 patients who were assigned to either the omidubicel group (n=62) or the standard UCB group (n=63). Overall disease characteristics were well balanced between both treatment arms. The omiducibel group included 48% females (30) vs the UCB group with 36% female patients (23). The median age of patients (more than 40) and the number of white patients (more than half) was quite similar between both the groups. 27 patients in omiducibel group had primary acute myeloid leukaemia in comparison to 33 in the UCB group.
The main objective of the study was to assess the efficacy and safety of myeloablative allogeneic stem cell transplantation using omiducibel or standard UCB grafting. The primary endpoint of the study was length of time to neutrophil engraftment.
Analysis of the data showed that the median time to engraftments was earlier (12 days) in the omiducibel group in comparison to UCB group (22 days, p<0.001). Also, the cumulative neutrophil engraftment incidences were increased in omidubicel (96%) vs standard (89%) group.
Patients treated with omiducibel showed a higher rate of platelet recovery by 42 days (55% vs 35% in the standard UCB group; P =.0028), lower incidence of first grade 2 or 3 bacterial or invasive fungal infections (37% vs 57% in the standard group; P = .027), and spend more time outside the hospital during first 100 days after transplantation (median, 61 vs 48 days in the standard group; P = .005).
However, the graft vs host disease as well as overall survival rate did not show any significant difference between both groups.
These findings show a faster hematopoietic recovery and reduced complications in transplantations with omiducibel. In conclusion, omiducibel should be used as standard treatment option for adult patients undergoing UCBT.
Horwitz ME, Stiff PJ, Cutler C, Brunstein C, Hanna R, Maziarz RT, et al. Omidubicel vs standard myeloablative umbilical cord blood transplantation: results of a phase 3 randomized study. Blood. 2021 Oct;138(16):1429–40.