Rationale for Conditioning Chemotherapy Choice and Dose Sample Clauses

Rationale for Conditioning Chemotherapy Choice and Dose. The rationale for the conditioning chemotherapy regimen and dose selection is based on the Phase 1 study conducted at the Pediatric Oncology Branch at the NCI (Xxx et al, 2015). In this study, 21 subjects (20 with ALL) were treated and all received the same fludarabine and cyclophosphamide schedule with a favorable benefit/risk profile. Consistent with the NCI protocol (Xxx et al, 2015), the KTE-X19-103 study will use the same Conditioning chemotherapy regimen consisting of fludarabine at a dose of 25 mg/m2/day IV over 30 minutes on Day -4, Day -3, Day -2 prior to KTE-X19 and cyclophosphamide at a dose of 900 mg/m2/day IV over 60 minutes on Day -2 prior to KTE-X19. Day -1 will be a rest day. The 3-day conditioning chemotherapy regimen may be administered in an outpatient setting in accordance with the daily dosing instructions outlined in Section 7.11.6.2. Following completion of each subjects’ conditioning chemotherapy regimen, subjects will receive their respective KTE-X19 infusion.
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