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• W4386021504 abstract "Background: Blinatumomab consolidation improves overall survival (OS) in adults with newly diagnosed B-cell ALL, regardless of measurable residual disease (MRD) status. We hypothesized that early incorporation of inotuzumab ozogamicin (INO) in patients (pts) with newly diagnosed Philadelphia chromosome (Ph)-negative B-cell ALL receiving frontline intensive chemotherapy plus blinatumomab would further deepen responses and improve outcome. Aims: We evaluated the efficacy and safety of hyper-CVAD with sequential blinatumomab, with or without INO, in pts with newly diagnosed Ph-negative B-cell ALL. Methods: Pts 14-59 years of age with newly diagnosed Ph-negative B-cell ALL, including pts who had received no more than 1 prior cycle of chemotherapy, were eligible. Pts were required to have a performance status of ≤3, total bilirubin ≤2 mg/dl, creatinine ≤2 mg/dl, and no significant CNS pathology (with the exception of CNS leukemia). Pts received hyper-CVAD alternating with high-dose methotrexate and cytarabine for up to 4 cycles, followed by 4 cycles of blinatumomab at standard doses. Pts with CD20+ disease (≥1% cells) received 8 doses of ofatumumab (2000 mg) or rituximab (375 mg/m2). Eight doses of prophylactic IT chemotherapy were given. Maintenance was with alternating blocks of POMP (given in maintenance cycles 1-3, 5-7, 9-11, and 13-15) and blinatumomab (given in maintenance cycles 4, 8, and 12). Those with high-risk disease features started blinatumomab after 2 cycles of hyper-CVAD. Beginning with pt #39, INO at a dose of 0.3 mg/m2 on day 1 and 8 was added to the 2 cycles of MTX/Ara-C and to 2 cycles of blinatumomab consolidation (4 total cycles with INO). Results: To date, 69 pts have been treated (38 without INO and 31 with INO). Baseline characteristics are summarized in Table 1. The median age was 34 years (range, 18-59). Among 53 pts with active disease at study entry, 100% achieved CR. MRD negativity by flow cytometry was achieved in 56/59 evaluable pts (95%). Two of the 3 pts who did not achieve MRD negativity were later found to have a NUP214::ABL1 fusion, and 1 had KMT2A rearrangement. The median follow-up of the entire cohort is 26 months (range, 4 to 73 months). Overall, 8 pts (12%) relapsed while on study, 22 (32%) underwent stem cell transplant (SCT) in first remission (2 of whom relapsed post-SCT), 2 (3%) died in CR, and 37 (54%) remain in continuous remission without SCT. For the entire cohort, the estimated 3-year OS was 87% and the 3-year continuous remission duration was 83%. With a median follow-up in the INO cohort of 15 months, 3 pts (10%) have relapsed, all with CNS-only relapses, and none has died. The 15-month OS in the cohorts with and without INO were 100% and 87%, respectively (P=0.06) (Figure 1). One patient discontinued blinatumomab due to recurrent grade 2 neurotoxicity. No pts have discontinued INO due to toxicity and no cases of SOS/VOD have been observed. Summary/Conclusion: In pts with newly diagnosed Ph-negative B-cell ALL receiving hyper-CVAD with sequential blinatumomab, the addition of INO is safe and may improve survival.Keywords: Acute lymphoblastic leukemia, Clinical trial, Phase II" @default.
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• W4386021504 date "2023-08-01" @default.
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• W4386021504 title "P358: HYPER-CVAD WITH BLINATUMOMAB AND INOTUZUMAB OZOGAMICIN FOR PATIENTS WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-NEGATIVE B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA: A PHASE II STUDY" @default.
• W4386021504 doi "https://doi.org/10.1097/01.hs9.0000968344.67564.ca" @default.
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