2016
A phase 2 trial of high dose lenalidomide in patients with relapsed/refractory higher‐risk myelodysplastic syndromes and acute myeloid leukaemia with trilineage dysplasia
Zeidan AM, Smith BD, Carraway HE, Gojo I, DeZern A, Gore SD. A phase 2 trial of high dose lenalidomide in patients with relapsed/refractory higher‐risk myelodysplastic syndromes and acute myeloid leukaemia with trilineage dysplasia. British Journal Of Haematology 2016, 176: 241-247. PMID: 27790720, DOI: 10.1111/bjh.14407.Peer-Reviewed Original ResearchConceptsHigh-risk myelodysplastic syndromeHigh-dose lenalidomideAcute myeloid leukemiaOverall survivalTrilineage dysplasiaMyelodysplastic syndromeMyeloid leukemiaNeutropenic fever/infectionInternational Working Group criteriaChemotherapy-ineligible patientsDoses of lenalidomideFever/infectionPoor-risk karyotypeRobust clinical activityMedian overall survivalPhase 2 trialPhase II trialKaplan-Meier methodElderly AMLII trialPrimary endpointFrontline therapyDosing schedulesGroup criteriaLimited therapies
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