What were the conditioning regimens used in the Kepivance® clinical trials prior to HSCT?
In the phase 2 and 3 clinical trials, patients received high-dose myeloablative therapy consisting of fractionated total-body irradiation (TBI) (12 Gy total dose), high-dose etoposide (60 mg/kg), and high-dose cyclophosphamide (100 mg/kg). TBI was delivered before the administration of chemotherapy in 6, 8, or 10 fractions over three or four days, with greater than six hours between fractions. Chemotherapy consisted of high-dose etoposide, administered on day -4 and one dose of high-dose cyclophosphamide, administered on day -2.1,2 In a phase 1 clinical trial, patients received BEAM, consisting of BCNU 300 mg/m2 IV on day -6, etoposide 200 mg/m2 daily IV and cytosine arabinoside 200 mg/m2 twice daily IV on days -5, -4, -3, and -2, and melphalan 140 mg/m2 IV on day -1.4,5 In a phase 1 clinical trial involving allogeneic patients, 2 different conditioning regimens were used depending on the study center. At center 1, patients received cyclophosphamide (60 mcg/kg/day) on days -7 and -8 an
