2022
A phase 1 study to evaluate the safety, pharmacology, and feasibility of continuous infusion nelarabine in patients with relapsed and/or refractory lymphoid malignancies
Boddu P, Senapati J, Ravandi‐Kashani F, Jabbour E, Jain N, Ayres M, Chen Y, Keating M, Kantarjian H, Gandhi V, Kadia T. A phase 1 study to evaluate the safety, pharmacology, and feasibility of continuous infusion nelarabine in patients with relapsed and/or refractory lymphoid malignancies. Cancer 2022, 129: 580-589. PMID: 36448227, DOI: 10.1002/cncr.34570.Peer-Reviewed Original ResearchConceptsPhase 1 studyT-cell prolymphocytic leukemiaComplete remissionContinuous infusionRefractory T-cell acute lymphoblastic leukemiaCentral nervous system toxicityIncomplete platelet recoveryRefractory lymphoid malignanciesT-cell acute lymphoblastic leukemiaUse of nelarabineFavorable clinical responseNervous system toxicityOverall response rateContinuous infusion scheduleAcute lymphoblastic leukemiaClinical responseCentral neurotoxicityLymphoblastic lymphomaMedian agePeripheral neuropathyInfusion scheduleSafety profilePatient populationLymphoblastic leukemiaPlatelet recovery
2020
Blast MRD AML-2: Blockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease (MDR) in Acute Myeloid Leukemia (AML) 2- a Randomized Phase 2 Study of the Venetoclax, Azacitidine, and Pembrolizumab Versus Venetoclax and Azacitidine As First Line Therapy in Older Patients with AML Who Are Ineligible or Who Refuse Intensive Chemotherapy
Zeidan A, Boddu P, Wood B, Zelterman D, Little R, Ivy S, Caldwell A, Sanchez-Espiridion B, Alatrash G, Sharon E, Radich J. Blast MRD AML-2: Blockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease (MDR) in Acute Myeloid Leukemia (AML) 2- a Randomized Phase 2 Study of the Venetoclax, Azacitidine, and Pembrolizumab Versus Venetoclax and Azacitidine As First Line Therapy in Older Patients with AML Who Are Ineligible or Who Refuse Intensive Chemotherapy. Blood 2020, 136: 11-12. DOI: 10.1182/blood-2020-139752.Peer-Reviewed Original ResearchEvent-free survivalDuration of responseMRD-negative CRIntensive chemotherapyOverall survivalDay 1Complete remissionFree survivalHematologic improvementOlder patientsSecondary AMLPD-1Study armsAML patientsInitial treatmentHematologic disordersLeukemia-specific T-cell responsesCancer Therapy Evaluation ProgramCR/complete remissionImmune cell subsets analysisRandomized phase 2 studyRandomized phase 2 trialRandomized phase II studyAllogeneic stem cell transplantBetter long-term clinical outcomes