Was is Rituximab proscri... 投稿者：Chauncey 投稿日：2026/01/11(Sun) 21:52 No.31035504 
RITUXAN together with chemotherapy was evaluated in Inter-B-NHL Ritux 2010 (NCT01516580), a multicenter, open-label, randomized trial of patients with beforehand untreated, superior stage, CD20-optimistic DLBCL/BL/BLL/B-AL aged 6 months and older. IV B-cell NHL or B-AL. LMB therapy was administered based mostly on the clinical group classification of group B (stage III with excessive LDH and non-central nervous system (CNS) (Stage IV), group C1 (B-AL, CNS optimistic and cerebrospinal fluid (CSF) unfavourable) and C3 (CSF optimistic). The trial was deliberate to enroll 600 patients with 1:1 randomization. The randomization was stopped early for efficacy after 362 patients had been enrolled (181 in every arm) in line with the primary deliberate interim evaluation outcome. A complete of 328 randomized patients, aged 6 months and older, had been included within the efficacy analyses, of which one affected person underneath three years of age obtained intravenous RITUXAN or non-U.S.-licensed rituximab together with LMB chemotherapy. Efficacy was established based mostly on occasion-free survival (EFS), the place an occasion was outlined as prevalence of progressive illness, relapse, second malignancy, loss of life from any trigger, or non-response as evidenced by detection of viable cells in residue after the second CYVE course, whichever happens first. Efficacy analyses have been carried out in 328 randomized patients with a median observe-up of 3.1 years. As of information cutoff date of 31 December 2017, there have been 20 and eight deaths reported in LMB arm and R-LMB arm, respectively, with an estimated total survival (OS) HR of 0.36 (95% CI, 0.Sixteen - 0.81). No formal statistical check was carried out for total survival and subsequently the OS consequence is taken into account descriptive.
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