Featured research from recent issues of Blood
Omidubicel Improves Outcomes , Reduces Hospital Stay for Patients With Hematologic Malignancies
Patients with hematologic malignancies who received umbilical cord blood transplantation with omidubicel engrafted faster , had fewer infections , and spent less time in the hospital , compared with patients who received a standard single or double umbilical cord blood graft , according to a recent study published in Blood .
“ The findings provide a strong argument in favor of omidubicel as the new standard of care for patients who are candidates for umbilical cord blood transplantation ,” said senior study author Mitchell Horwitz , MD , of Duke University Medical Center in Durham , North Carolina .
While omidubicel , which has yet to be approved for use , is not commercially available , “ it will soon be considered for approval by the regulatory agencies in both the U . S . and the E . U .,” noted Dr . Horwitz . “ Once approved , it is my belief that all patients who are candidates for a mismatched , myeloablative allogeneic stem cell transplantation should be considered for an omidubicel graft .”
Dr . Horwitz and colleagues randomly assigned patients with hematologic malignancies to either omidubicel ( n = 62 ) or standard umbilical cord blood transplant using standard single or double grafts ( n = 63 ) to compare the efficacy of the approaches .
Additionally , participants received myeloablative conditioning and graft-versus-host disease ( GVHD ) prophylaxis with mycophenolate mofetil 15 mg / kg three times per day and a calcineurin inhibitor ( tacrolimus at target trough levels 5-15 ng / ml or cyclosporine at target trough levels 200-400 ng / ml ).
The median age of patients in the study was 41 years ( range = 13-65 ) and the majority had either acute myeloid leukemia ( 48 %) or acute lymphocytic leukemia ( 33 %). Other malignancies included myelodysplastic syndromes , chronic myeloid leukemia , and lymphoma .
Patients in the omidubicel arm underwent transplant at a median of 41 days after randomization . In contrast , those in the standard cord transplant group underwent transplantation after a median of 26 days .
Median time to neutrophil engraftment – the primary endpoint of the study – was significantly shorter in the omidubicel group ( 12 vs . 22 days ; p < 0.001 ). By day 42 after transplant , the cumulative incidence of neutrophil engraftment was 96 % at 10 days for omidubicel versus 89 % at 20 days for the standard transplant ( p < 0.001 ).
Individuals assigned to omidubicel also had significantly
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faster platelet recovery ( 55 % vs . 35 % recovered by 42 days ; p = 0.028 ), lower incidence of first grade 2 / 3 bacterial or invasive fungal infections ( 37 % vs . 57 %; p = 0.027 ), and spent a greater median number of days out of the hospital during the first 100 days after transplant ( 61 vs . 48 days ; p = 0.005 ).
“ The findings provide a strong argument in favor of omidubicel as the new standard of care for patients who are candidates for umbilical cord blood transplantation .”
— Mitchell Horwitz , MD
To date , omidubicel has not yet been transplanted after reduced intensity or non-myeloablative bone marrow conditioning . “ Until such studies have been done ,” said Dr . Horwitz , “[ omidubicel ] is recommended for patients receiving myeloablative conditioning .”
While these results show a benefit with omidubicel compared with a standard umbilical cord blood graft , Dr . Horwitz said it is still unclear how outcomes will compare to recipients of other graft sources , such as a haploidentical or matched unrelated donor stem cells . ●
The authors report no relevant conflicts of interest .
Reference Horwitz ME , Stiff PJ , Cutler CS , et al . Omidubicel versus standard myeloablative umbilical cord blood transplantation : Results of a phase III randomized study [ published online ahead of print , 2021 Jun 22 .] Blood . doi : 10.1182 / blood . 2021011719 .
These findings represent an important advance in improving the use of umbilical cord blood as a donor source , with key implications for making umbilical cord blood transplantation safer and more accessible , particularly in minority populations that may lack human leukocyte antigen ( HLA ) -matched donors .
While the increasing reliance on post-transplant cyclophosphamide has made haploidentical and mismatched unrelated donor transplants an increasingly effective and favored approach to transplant , there are currently several questions related to this patient population , including those concerning the optimal donor source .
Additional questions include those related to impacts on resource utilization , further understanding and optimization of immune reconstitution after omidubicel , and the role of minimal residual disease and risk of relapse .
Although the study did not demonstrate any statistically significant differences in GVHD or survival between omidubicel and standard umbilical cord blood transplant , it should be noted that the study was not powered to detect survival differences .
Betty Ky Hamilton , MD Cleveland Clinic Cleveland , Ohio
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