Sit 2023: Omidubicel-onlv (Omisirge, Gamida Cell Ltd.) approbata est ab Administratione Cibus et medicamentis ad usum in aegris adultis et pediatricis (XII annis et supra) malignis hematologicis, quae ad umbilicum sanguinem recipiendum post myeloablativam conditionem transplantandi sunt. ut recuperatio neutrophil acceleraretur periculum infectionis demittere.
In Study P0501 (NCT02730299), an open-label, multicenter, randomised trial of omidubicel-onlv transplantation or unmanipulated cord blood (UCB) unit transplantation after myeloablative conditioning in patients with hematologic malignancies, the effectiveness and safety of the treatments were assessed. A total of 125 individuals were randomly assigned, with 62 receiving omidubicel-onlv and 63 receiving UCB. 52 patients had omidubicel-onlv transplantation, with a median dose of 9.0 X 106 cells/kg (range 2.1 – 47.6 X 106 cells/kg) of CD34+ cells. In the UCB arm, 56 patients had one or two cord units (66% received two cord units) implanted. The median CD34+ cell dose in the 42 patients who had post-thaw cell doses recorded was 0.2 X 106 cells/kg (range 0.0 – 0.8 X 106 cells/kg). There were other conditioning protocols utilised, such as those based on chemotherapy or Total Body Irradiation.
Time to neutrophil recovery after transplantation and the frequency of Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Grade 2/3 bacterial or Grade 3 fungal infections through Day 100 after transplantation were the primary efficacy outcome measures. The median time to neutrophil recovery was 12 days (95% CI: 10-15 days) for those receiving omidubicel-onlv, and 22 days (95% CI: 19-25 days) for those receiving UCB. In the omidubicel-onlv arm, 87% of patients and 83% of those receiving UCB experienced neutrophil recovery. Through Day 100 after transplantation, the incidence of BMT CTN Grade 2/3 bacterial or Grade 3 fungal infections was 39% and 60%, respectively, in the two groups.
Materia praescripta includit Monitum inclusum ad motus infusionem mortiferum vel minacem vitalem, insitum versus morbum exercitum (GvHD), syndromam insitam, et defectum insitum, simile cum medicamentis authenticis UCB. Omidubicel-onlv administrabatur pro quolibet morbo 117 singuli; eorum, 47% motus infusionem experti, 58% experti acuti GVHD, 35% experti chronici GVHD, et 3% experti insitam defectum.
Frequentissima Gradus 3-5 adversa responsa in Study P0501 aegroti cum malignitatibus hematologicis erant dolor (33%), inflammatio mucosalis (31%), hypertension (25%), et toxicitas gastrointestinalis (19%).
Suadetur dosis omidubicel-onlv duae sequentes infusiones quae ex his constant:
- Humanitas Fraction: minimum 8.0 108 totalis viable cellae cum minimum 8.7 cento CD34+ cellularum et minimum 9.2 107 totalis CD34+ cellulae, sequebatur
- a Non exculta Fraction: minimum 4.0 108 summa viable cellulas ad minimum 2.4 107 CD3+ cellulae.
Plena praescribens informationes de Omisirge hic praesto erit.
