FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W1433367056> ?p ?o ?g. }

• W1433367056 endingPage "2292" @default.
• W1433367056 startingPage "2292" @default.
• W1433367056 abstract "Abstract Introduction: Blinatumomab, an investigational bispecific T-cell engager (BiTE®) antibody construct, has been shown to induce remission in adult patients with relapsed/refractory BCP-ALL. Medically important adverse events (AEs) related to blinatumomab treatment in adults are cytokine release syndrome (CRS) and neurological events. We report the primary analysis of the phase 1 portion of a multicenter phase 1/2 study of blinatumomab in pediatric patients with relapsed/refractory BCP-ALL. Methods: In this continuing study, eligible patients are <18 years old and must have BCP-ALL that is in second or later bone marrow relapse, in any marrow relapse after allogeneic hematopoietic stem cell transplantation (HSCT), or refractory to induction or reinduction therapy. Patients receive blinatumomab for 28 days by continuous intravenous infusion followed by a 14-day treatment-free period (for up to five cycles). Escalating dosing levels of 5, 15, and 30 μg/m²/day and stepwise dosing of 5–15 or 15–30 μg/m²/day were evaluated. The primary endpoint of the phase 1 portion of the study was maximum tolerated dose (MTD). Secondary endpoints included toxicity, complete remission (CR) rate, overall survival (OS), relapse-free survival (RFS), pharmacokinetics evaluation, and cytokine measurement. Results: In the phase 1 portion, 41 patients received a total of 73 cycles (median of 2 cycles received, range of 1 to 5). Eight (20%) patients had refractory disease and seven (17%) had experienced at least two bone marrow relapses. Twenty-six (63%) patients had relapsed following HSCT. Dose-limiting toxicities (DLTs) are listed in Table 1. The MTD was established at 15 µg/m²/day. To decrease the risk of CRS, a stepwise dose of 5–15 μg/m²/day was recommended for the phase 2 part of the study (5 µg/m²/day for 7 days, then 15 µg/m²/day). This dose was subsequently assessed in two age groups (2–6 and 7–17 years) in the phase 1 expansion part with one of 18 patients developing grade 3 CRS. No patient in the expansion cohort developed grade 4 or 5 CRS. Across all dosing levels, 13 (32%) patients had CR with 10 (77%) achieving minimal residual disease (MRD) negativity. Of these 13 patients, nine (69%) underwent HSCT. Among patients who achieved CR, median RFS was 8.3 months (95% CI: 3.0–16.0 months). Median OS was 5.7 months (95% CI: 3.3–9.7 months; Figure 1) with a median follow-up time of 12.4 months. Across all dosing levels, the most common AEs regardless of causality were pyrexia (78%), headache (37%), hypertension (32%), nausea (29%), abdominal pain (27%), pain in the extremity (27%), and anemia (27%). Pharmacokinetic parameters, including steady-state concentration (Css), clearance, and half-life were similar to those from adult patients with relapsed/refractory BCP-ALL who received body surface area-based blinatumomab dosing. Transient elevations of serum cytokines were observed mostly within the first two days after starting blinatumomab, in particular IL-6, IFN-gamma, IL-10, and, to a lesser extent, IL-2 and TNF-α. Conclusions: In the phase 1 portion of this study in pediatric patients with relapsed/refractory BCP-ALL, the MTD was 15 µg/m²/day. CRS was dose-limiting, but stepwise dosing of 5–15 μg/m²/day has been effective in ameliorating CRS. Thirty-two percent of patients achieved CR and more than half were able to proceed to allogeneic HSCT. Figure 1 Figure 1. Disclosures von Stackelberg: Amgen: Consultancy, Honoraria. Off Label Use: This presentation will discuss the off-label use of blinatumomab, as this agent is not approved for use by the FDA, EMA or any other regulatory authorities.. Zugmaier:Amgen Inc.: Equity Ownership; Amgen Research (Munich) GmbH: Employment. Rheingold:Novartis: Consultancy. Hu:Amgen Inc.: Employment, Equity Ownership. Mergen:Amgen Inc.: Equity Ownership; Amgen Research (Munich) GmbH: Employment. Fischer:Amgen Inc.: Equity Ownership; Amgen Research (Munich) GmbH: Employment. Zhu:Amgen Inc.: Employment, Equity Ownership. Hijazi:Amgen Inc.: Equity Ownership; Amgen Research (Munich) GmbH: Employment. Gore:Amgen Inc.: Travel Support Other." @default.
• W1433367056 created "2016-06-24" @default.
• W1433367056 creator A5001066329 @default.
• W1433367056 creator A5011806164 @default.
• W1433367056 creator A5018621362 @default.
• W1433367056 creator A5022712318 @default.
• W1433367056 creator A5024202047 @default.
• W1433367056 creator A5028056789 @default.
• W1433367056 creator A5029816641 @default.
• W1433367056 creator A5030393361 @default.
• W1433367056 creator A5032050812 @default.
• W1433367056 creator A5035626095 @default.
• W1433367056 creator A5037169725 @default.
• W1433367056 creator A5038841996 @default.
• W1433367056 creator A5040001760 @default.
• W1433367056 creator A5057678079 @default.
• W1433367056 creator A5067126589 @default.
• W1433367056 creator A5076109830 @default.
• W1433367056 creator A5084414168 @default.
• W1433367056 creator A5084504988 @default.
• W1433367056 creator A5085057434 @default.
• W1433367056 creator A5085264071 @default.
• W1433367056 creator A5086181841 @default.
• W1433367056 date "2014-12-06" @default.
• W1433367056 modified "2023-10-18" @default.
• W1433367056 title "Phase 1/2 Study in Pediatric Patients with Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL) Receiving Blinatumomab Treatment" @default.
• W1433367056 doi "https://doi.org/10.1182/blood.v124.21.2292.2292" @default.
• W1433367056 hasPublicationYear "2014" @default.
• W1433367056 type Work @default.
• W1433367056 sameAs 1433367056 @default.
• W1433367056 citedByCount "17" @default.
• W1433367056 countsByYear W14333670562015 @default.
• W1433367056 countsByYear W14333670562016 @default.
• W1433367056 countsByYear W14333670562017 @default.
• W1433367056 countsByYear W14333670562018 @default.
• W1433367056 countsByYear W14333670562019 @default.
• W1433367056 countsByYear W14333670562021 @default.
• W1433367056 crossrefType "journal-article" @default.
• W1433367056 hasAuthorship W1433367056A5001066329 @default.
• W1433367056 hasAuthorship W1433367056A5011806164 @default.
• W1433367056 hasAuthorship W1433367056A5018621362 @default.
• W1433367056 hasAuthorship W1433367056A5022712318 @default.
• W1433367056 hasAuthorship W1433367056A5024202047 @default.
• W1433367056 hasAuthorship W1433367056A5028056789 @default.
• W1433367056 hasAuthorship W1433367056A5029816641 @default.
• W1433367056 hasAuthorship W1433367056A5030393361 @default.
• W1433367056 hasAuthorship W1433367056A5032050812 @default.
• W1433367056 hasAuthorship W1433367056A5035626095 @default.
• W1433367056 hasAuthorship W1433367056A5037169725 @default.
• W1433367056 hasAuthorship W1433367056A5038841996 @default.
• W1433367056 hasAuthorship W1433367056A5040001760 @default.
• W1433367056 hasAuthorship W1433367056A5057678079 @default.
• W1433367056 hasAuthorship W1433367056A5067126589 @default.
• W1433367056 hasAuthorship W1433367056A5076109830 @default.
• W1433367056 hasAuthorship W1433367056A5084414168 @default.
• W1433367056 hasAuthorship W1433367056A5084504988 @default.
• W1433367056 hasAuthorship W1433367056A5085057434 @default.
• W1433367056 hasAuthorship W1433367056A5085264071 @default.
• W1433367056 hasAuthorship W1433367056A5086181841 @default.
• W1433367056 hasConcept C121332964 @default.
• W1433367056 hasConcept C121608353 @default.
• W1433367056 hasConcept C126322002 @default.
• W1433367056 hasConcept C141071460 @default.
• W1433367056 hasConcept C142424586 @default.
• W1433367056 hasConcept C143998085 @default.
• W1433367056 hasConcept C197934379 @default.
• W1433367056 hasConcept C203092338 @default.
• W1433367056 hasConcept C2777288759 @default.
• W1433367056 hasConcept C2777408962 @default.
• W1433367056 hasConcept C2777701055 @default.
• W1433367056 hasConcept C2778020697 @default.
• W1433367056 hasConcept C2778461978 @default.
• W1433367056 hasConcept C2780007613 @default.
• W1433367056 hasConcept C2780850621 @default.
• W1433367056 hasConcept C2781107101 @default.
• W1433367056 hasConcept C2909962599 @default.
• W1433367056 hasConcept C2911091166 @default.
• W1433367056 hasConcept C29730261 @default.
• W1433367056 hasConcept C31760486 @default.
• W1433367056 hasConcept C3875195 @default.
• W1433367056 hasConcept C535046627 @default.
• W1433367056 hasConcept C71924100 @default.
• W1433367056 hasConcept C87355193 @default.
• W1433367056 hasConcept C90924648 @default.
• W1433367056 hasConceptScore W1433367056C121332964 @default.
• W1433367056 hasConceptScore W1433367056C121608353 @default.
• W1433367056 hasConceptScore W1433367056C126322002 @default.
• W1433367056 hasConceptScore W1433367056C141071460 @default.
• W1433367056 hasConceptScore W1433367056C142424586 @default.
• W1433367056 hasConceptScore W1433367056C143998085 @default.
• W1433367056 hasConceptScore W1433367056C197934379 @default.
• W1433367056 hasConceptScore W1433367056C203092338 @default.
• W1433367056 hasConceptScore W1433367056C2777288759 @default.
• W1433367056 hasConceptScore W1433367056C2777408962 @default.
• W1433367056 hasConceptScore W1433367056C2777701055 @default.
• W1433367056 hasConceptScore W1433367056C2778020697 @default.
• W1433367056 hasConceptScore W1433367056C2778461978 @default.
• W1433367056 hasConceptScore W1433367056C2780007613 @default.

• next