FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2564673721> ?p ?o ?g. }

• W2564673721 abstract "Abstract Abstract 2610 Introduction: Remission induction treatment in previously untreated intermediate/bad risk AML or high risk MDS needs continuous improvement. Clofarabine is a nucleoside analog with proven activity in acute leukemias. The aim of the study was to determine the recommended/maximum tolerated dose (MTD) of Clofarabine when administered with standard remission induction regimen (Ara-C and Idarubicin) in patients suffering from AML/MDS. Methods: This open label, 2-arm, multi-center, phase I trial included adult patients (pts) with previously untreated intermediate/bad risk AML or high risk MDS. All FAB subtypes except M3 and the cytogenetic groups, t(8;21) or inv(16) with WBC<100×109/l, were eligible. Pts with blast crisis of CML or CNS leukemia were excluded. Arm A: 1h infusion Clofarabine (10 mg/m2/d and 15 mg/m2/d) on d2, d4, d6, d8, d10; Ara-C continuous infusion (c.i.): 100 mg/m2/d on d1-d10, Idarubicin (i.v): 10 mg/m2/d, on d1, d3, d5. Arm B: push injection Clofarabine (10 mg/m2/d and 15 mg/m2/d on d2, d4, d6, d8, d10); Ara-C and Idarubicin same regimen as in arm A. A minimum of 3 pts per arm were to be included at each dose level. The next dose level was visited if none of the first 3 patients experienced a Dose Limiting Toxicity (DLT) at a certain dose level. DLT was defined as treatment-related adverse events: non-hematological grade III-IV toxicity (CTCAE 3.0) occurring during 8 weeks (except grade III events resolving to grade < III within 4 weeks) after the start of the remission induction, and/or hematological toxicity defined as bone marrow hypoplasia leading to neutrophil or platelet recovery (ANC > 0.5 × 109/l and platelets >50 × 109/l) later than 8 weeks after start of remission induction. If 1 out of the first 3 pts experienced a DLT, 3 additional pts were added (a maximum of 6 pts per dose level) in order to ensure the safety profile of this dose level. If a second patient experienced a DLT, no further pts were entered at that particular dose level. Dose escalation stopped and additional pts included at the previous lower dose to have a minimum of 6 pts treated at the recommended dose. Results: 25 pts have been entered into this phase I part in 3 participating sites. WHO PS status was 0 (N=16), 1 (N=8) or 2 (N=1). Age range was 25–60 years (median 55 years). 20 pts had de novo AML, 3 pts had secondary AML, 2 pts had de novo MDS (WHO RAEB-2). 7 pts had high cytogenetic risk features. In arm A and in arm B 10 mg/m2/d Clofarabine, and in arm A 15 mg/m2/d Clofarabine 6 pts each have been included. In arm B 15 mg/m2/d Clofarabine 7 pts were included, as one patient was substituted since she received 60% of total dose of Clofarabine and refused further treatment with Clofarabine due to related adverse event. All 25 pts were evaluable for DLT analysis. Overall, 5 pts with DLTs were observed: 1 in Arm A 10mg/m2/d Clofarabine, 3 in Arm A 15 mg/m2/d Clofarabine, 1 in Arm B 15 mg/m2/d Clofarabine. One patient with prolonged hematological toxicity as DLT reported in Arm A 10mg/m2/d Clofarabine. Two deaths in cytopenia/aplasia and one toxic death following sepsis/multiorgan failure have been reported as DLTs in 3 patients in both Arm A and B 15 mg/m2/d Clofarabine. The 5th patient had grade 4 anorexia, diarrhea, infection, prolonged hypoplasia and grade 3 confusion which classified as DLT in Arm A 15 mg/m2/d Clofarabine. In addition, three pts in the 15 mg/m2/d Clofarabine arms needed to be withdrawn from Clofarabine due to adverse events not classified as DLT. Main toxicity was bone marrow toxicity resulting in prolonged aplasia. Out of 25 pts, complete remission (CR) following induction 1/2 has been achieved in 19 pts: in 10/12 pts using 10 mg/m2/d Clofarabine (5 pts each in Arm A and Arm B) and in 9/13 pts using 15 mg/m2/d Clofarabine (4 pts in Arm A and 5 pts in Arm B). In addition CR with incomplete blood count recovery (CRi) following induction 1/2 was observed in 2 pts: 1 in Arm A 10 mg/m2/d Clofarabine and 1 in Arm B 15 mg/m2/d Clofarabine. Conclusion: Infusion of 15 mg/m2/d Clofarabine resulted in a high rate of DLTs (4/13 pts) and early treatment withdrawals (3/13 pts). The infusion of 10 mg/m2/d Clofarabine had an acceptable rate of DLTs (1/12 pts), no early treatment withdrawals occurred, and a high CR/CRi rate (11/12 pts) was observed. Therefore the MTD of Clofarabine in combination with Ara-C and Idarubicin is defined at 10 mg/m2/d and will be the recommended dose for the phase II part of this study. Disclosures: Willemze: Genzyme: member advisory committee clofarabine. Muus:Amgen: Membership on an entity's Board of Directors or advisory committees. de Witte:Novartis: Consultancy, Honoraria, Speakers Bureau." @default.
• W2564673721 created "2017-01-06" @default.
• W2564673721 creator A5014779991 @default.
• W2564673721 creator A5020621642 @default.
• W2564673721 creator A5031364930 @default.
• W2564673721 creator A5032033167 @default.
• W2564673721 creator A5034871851 @default.
• W2564673721 creator A5055966861 @default.
• W2564673721 creator A5063170420 @default.
• W2564673721 creator A5070417705 @default.
• W2564673721 creator A5072099748 @default.
• W2564673721 creator A5078192708 @default.
• W2564673721 creator A5079852624 @default.
• W2564673721 creator A5080855457 @default.
• W2564673721 date "2011-11-18" @default.
• W2564673721 modified "2023-09-28" @default.
• W2564673721 title "Clofarabine in Combination with a Standard Remission Induction Regimen (AraC and idarubicin) in Patients with Previously Untreated Intermediate and Bad Risk Acute Myelogenous Leukemia (AML) or High Risk Myelodysplasia (MDS):Phase I Results of An Ongoing Phase I/II Study of the EORTC-LG and GIMEMA(EORTC GIMEMA 06061/AML-14A trial)" @default.
• W2564673721 doi "https://doi.org/10.1182/blood.v118.21.2610.2610" @default.
• W2564673721 hasPublicationYear "2011" @default.
• W2564673721 type Work @default.
• W2564673721 sameAs 2564673721 @default.
• W2564673721 citedByCount "0" @default.
• W2564673721 crossrefType "journal-article" @default.
• W2564673721 hasAuthorship W2564673721A5014779991 @default.
• W2564673721 hasAuthorship W2564673721A5020621642 @default.
• W2564673721 hasAuthorship W2564673721A5031364930 @default.
• W2564673721 hasAuthorship W2564673721A5032033167 @default.
• W2564673721 hasAuthorship W2564673721A5034871851 @default.
• W2564673721 hasAuthorship W2564673721A5055966861 @default.
• W2564673721 hasAuthorship W2564673721A5063170420 @default.
• W2564673721 hasAuthorship W2564673721A5070417705 @default.
• W2564673721 hasAuthorship W2564673721A5072099748 @default.
• W2564673721 hasAuthorship W2564673721A5078192708 @default.
• W2564673721 hasAuthorship W2564673721A5079852624 @default.
• W2564673721 hasAuthorship W2564673721A5080855457 @default.
• W2564673721 hasConcept C126322002 @default.
• W2564673721 hasConcept C141071460 @default.
• W2564673721 hasConcept C2777198975 @default.
• W2564673721 hasConcept C2778041864 @default.
• W2564673721 hasConcept C2778461978 @default.
• W2564673721 hasConcept C2779117419 @default.
• W2564673721 hasConcept C2781413609 @default.
• W2564673721 hasConcept C71924100 @default.
• W2564673721 hasConcept C90924648 @default.
• W2564673721 hasConceptScore W2564673721C126322002 @default.
• W2564673721 hasConceptScore W2564673721C141071460 @default.
• W2564673721 hasConceptScore W2564673721C2777198975 @default.
• W2564673721 hasConceptScore W2564673721C2778041864 @default.
• W2564673721 hasConceptScore W2564673721C2778461978 @default.
• W2564673721 hasConceptScore W2564673721C2779117419 @default.
• W2564673721 hasConceptScore W2564673721C2781413609 @default.
• W2564673721 hasConceptScore W2564673721C71924100 @default.
• W2564673721 hasConceptScore W2564673721C90924648 @default.
• W2564673721 hasLocation W25646737211 @default.
• W2564673721 hasOpenAccess W2564673721 @default.
• W2564673721 hasPrimaryLocation W25646737211 @default.
• W2564673721 hasRelatedWork W1256614177 @default.
• W2564673721 hasRelatedWork W2340871778 @default.
• W2564673721 hasRelatedWork W2488091784 @default.
• W2564673721 hasRelatedWork W2514593910 @default.
• W2564673721 hasRelatedWork W2531135360 @default.
• W2564673721 hasRelatedWork W2547496328 @default.
• W2564673721 hasRelatedWork W2554835841 @default.
• W2564673721 hasRelatedWork W2554946963 @default.
• W2564673721 hasRelatedWork W2558140751 @default.
• W2564673721 hasRelatedWork W2563846585 @default.
• W2564673721 hasRelatedWork W2572345794 @default.
• W2564673721 hasRelatedWork W2578847309 @default.
• W2564673721 hasRelatedWork W2586119582 @default.
• W2564673721 hasRelatedWork W2586661143 @default.
• W2564673721 hasRelatedWork W2587892792 @default.
• W2564673721 hasRelatedWork W2589987812 @default.
• W2564673721 hasRelatedWork W2594660202 @default.
• W2564673721 hasRelatedWork W2979299255 @default.
• W2564673721 hasRelatedWork W2979899130 @default.
• W2564673721 hasRelatedWork W2981035972 @default.
• W2564673721 isParatext "false" @default.
• W2564673721 isRetracted "false" @default.
• W2564673721 magId "2564673721" @default.
• W2564673721 workType "article" @default.