2024
Initial Results from the QTc Substudy of the IMerge Phase 3 Trial Demonstrate Clinically Meaningful Efficacy, Manageable Safety, and Absence of Proarrhythmic Risk in Patients with Lower-Risk Myelodysplastic Syndromes Who Received Prior Therapies Beyond Erythropoiesis Stimulating Agents
Komrokji R, Santini V, Platzbecker U, Van Eygen K, Diez-Campelo M, De Paz R, Sanz G, Thépot S, Kaźmierczak M, Oliva E, Sekeres M, Fenaux P, Madanat Y, Savona M, Riggs J, Dougherty S, Lennox A, Xia Q, Sun L, Berry T, Zeidan A. Initial Results from the QTc Substudy of the IMerge Phase 3 Trial Demonstrate Clinically Meaningful Efficacy, Manageable Safety, and Absence of Proarrhythmic Risk in Patients with Lower-Risk Myelodysplastic Syndromes Who Received Prior Therapies Beyond Erythropoiesis Stimulating Agents. Blood 2024, 144: 4590-4590. DOI: 10.1182/blood-2024-200885.Peer-Reviewed Original ResearchLower-risk myelodysplastic syndromesErythropoiesis-stimulating agentsHematological improvement-erythroidFood and Drug AdministrationRBC-TIPhase 3 trialPlacebo recipientsHypomethylating agentsInternational Working GroupData cutoffMyelodysplastic syndromeTransfusion reductionRed blood cellsProarrhythmic riskProgression to acute myeloid leukemiaErythropoiesis-stimulating agent useConcentration-QT relationshipEffects of imetelstatRBC transfusion independenceGrade 3/4 neutropeniaMedian treatment durationKaplan-Meier methodologyClinically meaningful efficacyUnited States Food and Drug AdministrationAcute myeloid leukemia
2013
Validation Of a Brief Arsenic Trioxide (ATO)-Based Consolidation Chemotherapy In The Upfront Management Of Acute Promyelocytic Leukemia (APL): Less Anthracycline Exposure and Faster Completion Of Consolidation Therapy With Equivalent Survival
Leech M, Stewart M, Zhang X, Bashey A, Holland H, Solomon S, Carraway H, Smith B, Morris L, Gore S, Zeidan A. Validation Of a Brief Arsenic Trioxide (ATO)-Based Consolidation Chemotherapy In The Upfront Management Of Acute Promyelocytic Leukemia (APL): Less Anthracycline Exposure and Faster Completion Of Consolidation Therapy With Equivalent Survival. Blood 2013, 122: 3963. DOI: 10.1182/blood.v122.21.3963.3963.Peer-Reviewed Original ResearchAcute promyelocytic leukemiaLeukemia-free survivalComplete remissionOverall survivalAnthracycline exposureConsolidation chemotherapyMaintenance therapyIntensive therapyOriginal trialM2/dATRA-ATO combinationContinuous infusion cytarabineSignificant cardiac toxicityLow-risk diseaseMonths of therapyHigh-risk diseaseKaplan-Meier methodologyOriginal clinical trialsCourse of therapyCompletion of protocolTrans retinoic acidChemotherapy consolidationConsolidation therapyInduction therapyIntravenous daunorubicin