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Omidubicel vs standard myeloablative umbilical cord blood transplantation: results of a phase 3 randomized study.
Horwitz, Mitchell E; Stiff, Patrick J; Cutler, Corey; Brunstein, Claudio; Hanna, Rabi; Maziarz, Richard T; Rezvani, Andrew R; Karris, Nicole A; McGuirk, Joseph; Valcarcel, David; Schiller, Gary J; Lindemans, Caroline A; Hwang, William Y K; Koh, Liang Piu; Keating, Amy; Khaled, Yasser; Hamerschlak, Nelson; Frankfurt, Olga; Peled, Tony; Segalovich, Irit; Blackwell, Beth; Wease, Stephen; Freedman, Laurence S; Galamidi-Cohen, Einat; Sanz, Guillermo.
Afiliación
  • Horwitz ME; Duke University Medical Center, Durham, NC.
  • Stiff PJ; Loyola University Medical Center, Chicago, IL.
  • Cutler C; Dana-Farber Cancer Institute, Boston MA.
  • Brunstein C; University of Minnesota, Minneapolis, MN.
  • Hanna R; Taussig Cancer Institute, Department of Hematology & Medical Oncology, Cleveland Clinic, Cleveland, OH.
  • Maziarz RT; Oregon Health and Science University, Portland, OR.
  • Rezvani AR; Stanford University Cancer Institute, Palo Alto, CA.
  • Karris NA; City of Hope, Duarte, CA.
  • McGuirk J; University of Kansas Medical Center, Westwood, KS.
  • Valcarcel D; Department of Hematology, University Hospital Vall d'Hebron, Barcelona, Spain.
  • Schiller GJ; David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA.
  • Lindemans CA; Princes Maxima Children's Hospital and the Department of Pediatrics, University Medical Center, University of Utrecht, Utrecht, The Netherlands.
  • Hwang WYK; Singapore General Hospital, Singapore and National Cancer Centre of Singapore, Singapore.
  • Koh LP; National University Cancer Institute, National University Health System Singapore, Singapore.
  • Keating A; Childrens Hospital Colorado, Aurora, CO.
  • Khaled Y; Methodist University Hospital, Memphis, TN.
  • Hamerschlak N; Israelita Albert Einstein Hospital, Sao Paolo, Brazil.
  • Frankfurt O; Northwestern University, Chicago, IL.
  • Peled T; Gamida Cell, Jerusalem, Israel.
  • Segalovich I; Gamida Cell, Jerusalem, Israel.
  • Blackwell B; Emmes Corporation, Rockville, MD.
  • Wease S; Emmes Corporation, Rockville, MD.
  • Freedman LS; Gertner Institute for Epidemiology and Health Policy Research, Sheba Medical Center, Tel Hashomer, Israel; and.
  • Galamidi-Cohen E; Gamida Cell, Jerusalem, Israel.
  • Sanz G; Hematology Department, Hospital Universitari i Politècnic La Fe, Valencia, Spain.
Blood ; 138(16): 1429-1440, 2021 10 21.
Article en En | MEDLINE | ID: mdl-34157093
Omidubicel is an ex vivo expanded hematopoietic progenitor cell and nonexpanded myeloid and lymphoid cell product derived from a single umbilical cord blood unit. We report results of a phase 3 trial to evaluate the efficacy of omidubicel compared with standard umbilical cord blood transplantation (UCBT). Between January 2017 and January 2020, 125 patients age 13 to 65 years with hematologic malignancies were randomly assigned to omidubicel vs standard UCBT. Patients received myeloablative conditioning and prophylaxis with a calcineurin inhibitor and mycophenolate mofetil for graft-versus-host disease (GVHD). The primary end point was time to neutrophil engraftment. The treatment arms were well balanced and racially diverse. Median time to neutrophil engraftment was 12 days (95% confidence interval [CI], 10-14 days) for the omidubicel arm and 22 days (95% CI, 19-25 days) for the control arm (P < .001). The cumulative incidence of neutrophil engraftment was 96% for patients receiving omidubicel and 89% for patients receiving control transplants. The omidubicel arm had faster platelet recovery (55% vs 35% recovery by 42 days; P = .028), had a lower incidence of first grade 2 to 3 bacterial or invasive fungal infection (37% vs 57%; P = .027), and spent more time out of hospital during the first 100 days after transplant (median, 61 vs 48 days; P = .005) than controls. Differences in GVHD and survival between the 2 arms were not statistically significant. Transplantation with omidubicel results in faster hematopoietic recovery and reduces early transplant-related complications compared with standard UCBT. The results suggest that omidubicel may be considered as a new standard of care for adult patients eligible for UCBT. The trial was registered at www.clinicaltrials.gov as #NCT02730299.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Hematológicas / Trasplante de Células Madre de Sangre del Cordón Umbilical / Sangre Fetal Tipo de estudio: Clinical_trials / Etiology_studies Límite: Adolescent / Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Blood Año: 2021 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Hematológicas / Trasplante de Células Madre de Sangre del Cordón Umbilical / Sangre Fetal Tipo de estudio: Clinical_trials / Etiology_studies Límite: Adolescent / Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Blood Año: 2021 Tipo del documento: Article Pais de publicación: Estados Unidos