2019
Landmark Response and Survival Analyses from 102 MDS and CMML Patients Treated with Guadecitabine in a Phase 2 Study Showing That Maximum Response and Survival Is Best Achieved with Adequate Treatment Duration
Savona M, Kantarjian H, Roboz G, O'Connell C, Walsh K, Tibes R, Yee K, Stock W, Griffiths E, Jabbour E, Lunin S, Rosenblat T, Podoltsev N, Issa J, Su X, Azab M, Garcia-Manero G. Landmark Response and Survival Analyses from 102 MDS and CMML Patients Treated with Guadecitabine in a Phase 2 Study Showing That Maximum Response and Survival Is Best Achieved with Adequate Treatment Duration. Blood 2019, 134: 2957. DOI: 10.1182/blood-2019-129962.Peer-Reviewed Original ResearchMDS/CMML patientsMDS/CMMLPhase 2 studyObjective responseCMML patientsSurvival benefitClinical trialsMedian OSMyelodysplastic syndromeAstex PharmaceuticalsSurvival analysisTreatment discontinuationHematological improvementPartial responseComplete responseEarly progressionOtsuka PharmaceuticalDaiichi SankyoLandmark analysisHMA treatmentLandmark responsesCycle 4Prospective phase 2 studyBoehringer IngelheimAdvisory Committee
2018
Long Term Results of a Randomized Phase 2 Dose-Response Study of Guadecitabine, a Novel Subcutaneous (SC) Hypomethylating Agent (HMA), in 102 Patients with Intermediate or High Risk Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML)
Garcia-Manero G, Ritchie E, Walsh K, Savona M, Kantarjian H, Kropf P, O'Connell C, Tibes R, Daver N, Jabbour E, Lunin S, Rosenblat T, Yee K, Stock W, Griffiths E, Mace J, Podoltsev N, Berdeja J, Issa J, Naim S, Hao Y, Azab M, Roboz G. Long Term Results of a Randomized Phase 2 Dose-Response Study of Guadecitabine, a Novel Subcutaneous (SC) Hypomethylating Agent (HMA), in 102 Patients with Intermediate or High Risk Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML). Blood 2018, 132: 231. DOI: 10.1182/blood-2018-99-110465.Peer-Reviewed Original ResearchMedian overall survivalOverall survivalDose groupMyelodysplastic syndromeTreatment-naïveChronic myelomonocytic leukemiaCMML patientsBristol-Myers SquibbHypomethylating agentAdverse eventsAstex PharmaceuticalsM2 groupMDS patientsMD cohortJazz PharmaceuticalsMarrow CRBM blastsHematological improvementMost patientsSpeakers bureauDaiichi SankyoHMA treatmentJanssen PharmaceuticalsTP53 mutationsCelgene CorporationImpact of Leukapheresis and Time to Chemotherapy on Outcomes of Newly Diagnosed Patients (pts) with Acute Myeloid Leukemia (AML) Presenting with Hyperleukocytosis: An Analysis from a Large International Patient Cohort
Stahl M, Wei W, Montesinos P, Lengline E, Shallis R, Neukirchen J, Bhatt V, Sekeres M, Fathi A, Konig H, Luger S, Khan I, Roboz G, Cluzeau T, Martínez-Cuadron D, Raffoux E, Germing U, Umakanthan J, Mukherjee S, Brunner A, Miller A, McMahon C, Ritchie E, Rodríguez-Veiga R, Itzykson R, Boluda B, Rabian F, Tormo M, Cruz E, Rabinovich E, Yoo B, Podoltsev N, Gore S, Zeidan A. Impact of Leukapheresis and Time to Chemotherapy on Outcomes of Newly Diagnosed Patients (pts) with Acute Myeloid Leukemia (AML) Presenting with Hyperleukocytosis: An Analysis from a Large International Patient Cohort. Blood 2018, 132: 1428. DOI: 10.1182/blood-2018-99-112495.Peer-Reviewed Original ResearchWhite blood cell countInitiation of ICSAcute myeloid leukemiaUse of leukapheresisImpact of leukapheresisTumor lysis syndromeHours of presentationOdds of deathCytogenetic risk groupOverall survivalTime of presentationUnivariate analysisMultivariate analysisAstex PharmaceuticalsSpeakers bureauHazard ratioDaiichi SankyoRisk groupsEastern Cooperative Oncology Group performance statusJanssen PharmaceuticalsJazz PharmaceuticalsCleveland Clinic Taussig Cancer InstituteAdverse cytogenetic risk groupPoor cytogenetic risk groupCelgene CorporationCharacteristics, Treatment Patterns and Outcomes Among Newly Diagnosed Patients (pts) with Acute Myeloid Leukemia (AML) Who Present with Hyperleukocytosis: Findings from a Large International Patient Cohort
Stahl M, Wei W, Montesinos P, Lengline E, Shallis R, Neukirchen J, Bhatt V, Sekeres M, Fathi A, Konig H, Luger S, Khan I, Roboz G, Cluzeau T, Martínez-Cuadron D, Raffoux E, Germing U, Umakanthan J, Mukherjee S, Brunner A, Miller A, McMahon C, Ritchie E, Rodríguez-Veiga R, Itzykson R, Boluda B, Rabian F, Tormo M, Cruz E, Rabinovich E, Yoo B, Podoltsev N, Gore S, Zeidan A. Characteristics, Treatment Patterns and Outcomes Among Newly Diagnosed Patients (pts) with Acute Myeloid Leukemia (AML) Who Present with Hyperleukocytosis: Findings from a Large International Patient Cohort. Blood 2018, 132: 4040. DOI: 10.1182/blood-2018-99-112974.Peer-Reviewed Original ResearchWhite blood cell countMedian overall survivalAcute myeloid leukemiaHematopoietic stem cell transplantIntensive chemotherapyTumor lysis syndromeOverall survivalTime of presentationComplete remissionAstex PharmaceuticalsSpeakers bureauPartial remissionTreatment patternsDaiichi SankyoJazz PharmaceuticalsCleveland Clinic Taussig Cancer InstituteJanssen PharmaceuticalsMedian white blood cell countHigher white blood cell countCelgene CorporationLong-term clinical outcomesAdvisory CommitteeImpact of leukapheresisIncomplete count recoveryMDS International FoundationOutcomes of Patients with Newly-Diagnosed Acute Myeloid Leukemia and Hyperleukocytosis Who Did Not Undergo Intensive Chemotherapy: Results from a Large International Database
Shallis R, Stahl M, Wei W, Montesinos P, Lengline E, Neukirchen J, Bhatt V, Sekeres M, Fathi A, Konig H, Luger S, Khan I, Roboz G, Cluzeau T, Martínez-Cuadron D, Raffoux E, Germing U, Umakanthan J, Mukherjee S, Brunner A, Miller A, McMahon C, Ritchie E, Rodríguez-Veiga R, Itzykson R, Boluda B, Rabian F, Tormo M, Cruz E, Podoltsev N, Gore S, Zeidan A. Outcomes of Patients with Newly-Diagnosed Acute Myeloid Leukemia and Hyperleukocytosis Who Did Not Undergo Intensive Chemotherapy: Results from a Large International Database. Blood 2018, 132: 3999. DOI: 10.1182/blood-2018-99-119755.Peer-Reviewed Original ResearchTumor lysis syndromeIntensive chemotherapyIntensive care unitOverall survivalClinical evidenceAstex PharmaceuticalsSpeakers bureauDaiichi SankyoMedian OSWorse OSAML patientsPlatelet countEastern Cooperative Oncology Group performance statusJazz PharmaceuticalsCleveland Clinic Taussig Cancer InstituteJanssen PharmaceuticalsOne-year OS probabilityCelgene CorporationAdvisory CommitteeMDS International FoundationPoor-risk AMLBest supportive careLow-dose cytarabineMedian overall survivalOutcomes of patients
2014
First Clinical Results of a Randomized Phase 2 Dose-Response Study of SGI-110, a Novel Subcutaneous (SC) Hypomethylating Agent (HMA), in 102 Patients with Intermediate (Int) or High Risk (HR) Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML)
Garcia-Manero G, Ritchie E, Walsh K, Savona M, Kropf P, O’Connell C, Tibes R, Daver N, Jabbour E, Lunin S, Rosenblat T, Yee K, Stock W, Griffiths E, Mace J, Podoltsev N, Berdeja J, Issa J, Chung W, Naim S, Taverna P, Hao Y, Azab M, Kantarjian H, Roboz G. First Clinical Results of a Randomized Phase 2 Dose-Response Study of SGI-110, a Novel Subcutaneous (SC) Hypomethylating Agent (HMA), in 102 Patients with Intermediate (Int) or High Risk (HR) Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML). Blood 2014, 124: 529. DOI: 10.1182/blood.v124.21.529.529.Peer-Reviewed Original ResearchTreatment-naïve patientsMyelodysplastic syndromeChronic myelomonocytic leukemiaTreatment armsCMML patientsHypomethylating agentClinical responseAdverse eventsAstex PharmaceuticalsSGI-110Marrow CRNaïve patientsTransfusion independenceHematological improvementMDS patientsHigh-risk myelodysplastic syndromePhase 1 clinical trialECOG PS 2Treatment-naïve groupRisk myelodysplastic syndromesBaseline patient characteristicsFirst clinical resultsDose-response studySignificant differencesMedian follow
2013
First Clinical Results Of a Randomized Phase 2 Study Of SGI-110, a Novel Subcutaneous (SQ) Hypomethylating Agent (HMA), In Adult Patients With Acute Myeloid Leukemia (AML)
Kantarjian H, Jabbour E, Yee K, Kropf P, O'Connell C, Stock W, Tibes R, Rizzieri D, Walsh K, Griffiths E, Roboz G, Savona M, Ervin T, Podoltsev N, Pemmaraju N, Daver N, Garcia-Manero G, Borthakur G, Wierda W, Ravandi F, Cortes J, Brandwein J, Odenike O, Feldman E, Chung W, Naim S, Choy G, Taverna P, Hao Y, Dimitrov G, Azab M, Issa J. First Clinical Results Of a Randomized Phase 2 Study Of SGI-110, a Novel Subcutaneous (SQ) Hypomethylating Agent (HMA), In Adult Patients With Acute Myeloid Leukemia (AML). Blood 2013, 122: 497. DOI: 10.1182/blood.v122.21.497.497.Peer-Reviewed Original ResearchAcute myeloid leukemiaPhase 2 studyTreatment of AMLRandomized phase 2 studyRefractory acute myeloid leukemiaOverall remission rateAdverse eventsComplete remissionRemission rateAstex PharmaceuticalsHypomethylating agentAML patientsSGI-110Primary endpointDose groupElderly acute myeloid leukemiaLINE-1 demethylationElderly AML patientsCommon adverse eventsComplete remission ratePhase 1 trialStem cell transplantPhase 3 investigationFirst clinical resultsECOG PS