2020
AML-187: The STIMULUS Clinical Trial Program: Evaluating Combination Therapy with MBG453 in Patients with Higher-Risk Myelodysplastic Syndrome (HR-MDS) or Acute Myeloid Leukemia
Zeidan A, Esteve J, Kim H, Miyazaki Y, Platzbecker U, Schuh A, Westermann J, Malek K, Scott J, Niolat J, Peyrard S, Kiertsman F, Stegert M, Fenaux P. AML-187: The STIMULUS Clinical Trial Program: Evaluating Combination Therapy with MBG453 in Patients with Higher-Risk Myelodysplastic Syndrome (HR-MDS) or Acute Myeloid Leukemia. Clinical Lymphoma Myeloma & Leukemia 2020, 20: s188. DOI: 10.1016/s2152-2650(20)30727-8.Peer-Reviewed Original ResearchHigh-risk myelodysplastic syndromeEvent-free survivalClinical trial programLeukemia-free survivalProgression-free survivalOverall survivalTrial programEligible patientsSecondary endpointsTransfusion independenceCombination therapyAnti-Tim-3 monoclonal antibodyCR/CRi rateMultiple immune cell typesHigher risk MDSMRD negative ratePhase 1b studyOpen-label studyComplete remission rateDouble-blind studyRelapse-free survivalGood safety profileAcute myeloid leukemiaImmune cell typesLeukemic stem cells
2015
Results of a Phase 2 Trial of High Dose Lenalidomide Monotherapy in Patients with Relapsed/Refractory Higher-Risk Myelodysplastic Syndromes or Acute Myeloid Leukemia with Trilineage Dysplasia
Zeidan A, Smith B, Carraway H, Gojo I, Sakoian S, Gore S, DeZern A. Results of a Phase 2 Trial of High Dose Lenalidomide Monotherapy in Patients with Relapsed/Refractory Higher-Risk Myelodysplastic Syndromes or Acute Myeloid Leukemia with Trilineage Dysplasia. Blood 2015, 126: 2901. DOI: 10.1182/blood.v126.23.2901.2901.Peer-Reviewed Original ResearchHigh-risk myelodysplastic syndromeOverall hematologic response rateHigh-dose lenalidomideCycles of lenalidomideNon-hematologic toxicitiesAcute myeloid leukemiaOverall survivalTrilineage dysplasiaEntire cohortMyelodysplastic syndromePlatelet countGrade 3Myeloid leukemiaInternational Working Group 2006 criteriaJohns Hopkins Institutional Review BoardMedian white blood cell countSingle-arm phase II studyBone marrow blast percentageUnderwent bone marrow transplantationWhite blood cell countPhase 2 clinical trialHematologic response rateHigher risk MDSPoor-risk karyotypeCycles of therapy
2013
Azacitidine With Or Without Entinostat For The Treatment Of Therapy-Related Myeloid Neoplasm: Further Results Of The E1905 North American Leukemia Intergroup Study
Prebet T, Sun Z, Ketterling R, Greenberg P, Zeidan A, Litzow M, Gabrilove J, Erba H, Paietta E, Czader M, Gore S, Tallman M. Azacitidine With Or Without Entinostat For The Treatment Of Therapy-Related Myeloid Neoplasm: Further Results Of The E1905 North American Leukemia Intergroup Study. Blood 2013, 122: 2777. DOI: 10.1182/blood.v122.21.2777.2777.Peer-Reviewed Original ResearchTherapy-related myeloid neoplasmsAcute myeloid leukemiaAZA monotherapyMyeloid neoplasmsResponse rateRisk cytogeneticsCombination armMyeloid leukemiaDe novo MDS/AMLRandomized phase 2 studyECOG PS 0Higher risk MDSLeukemia intergroup studyMost prospective trialsNovo MDS patientsT-MN patientsUnfavorable-risk cytogeneticsUse of azacitidineIntermediate-risk cytogeneticsMedian overall survivalHigh-risk patientsPhase 2 studyPoor prognosis subgroupStem cell transplantPeripheral blood counts