Nikolai Podoltsev, MD, PhD

Assistant Professor of Medicine (Hematology); Associate Director of the Hematology/Oncology Fellowship Program

Research Departments & Organizations

Internal Medicine: Hematology

Yale Cancer Center: Developmental Therapeutics

Office of Cooperative Research

Research Summary

My research interest includes management of malignant hematology conditions such as acute leukemias (focus on treatment of older adults with AML, ALL as well as treatment of AML patients with FLT-3 inhibitors), myelodysplastic syndromes (MDS) and myeloprolipherative neoplasms (MPNs). I am currently serving as a Yale principle investigator for a number of clinical studies including industry-sponsored, cooperative group and investigator initiated trials (IITs) looking at the efficacy of different novel agents for patients with malignant hematological conditions who otherwise have very limited treatment options. I am working on IITs for patients with high risk myelofibrosis and accelerated/blast forms of MPNs. I participate in hematology group of Yale University Cancer Outcomes, Public Policy and Effectiveness Research (COPPER) Center to study myeloid neoplasms epidemiology and outcomes with special interest in MPNs. I am involved in a number of retrospective projects looking at different aspects of management and outcomes among patients with AML and MDS using Yale myeloid malignancies database in collaboration with other institutions. As an associate program director of the hematology/oncology fellowship program I am interested in fellows’ career choices with respect to hematology with plans to participate in the national study with the support of American Society of Hematology (ASH) Committee on Training.

Clinical Trials

Conditions Study Title
Leukemia, other Phase 1b Dose Escalation followed by Phase 2 treatment. Participants will be evaluable for inclusion in the Phase 1b and Phase 2 portions of the study if they receive at least one dose of protocol therapy.
Leukemia, not otherwise specified, Leukemia, other, Myeloid and Monocytic Leukemia A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Placebo for the Treatment of Anemia Due to the IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in Subjects With Ring Sideroblasts Who Require Red Blood Cell Transfusions.
Leukemia, other Phase III Randomized Study of Crenolanib Versus Midostaurin Administered Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed Subjects With FLT3 Mutated Acute Myeloid Leukemia
Leukemia, not otherwise specified, Leukemia, other An International Phase Ib Multicentre Study to Characterize the Safety and Tolerability of Intravenously Administered S64315 a Selective Mcl-1 Inhibitor, in Combination With Orally Administered Venetoclax a Selective Bcl-2 Inhibitor in Patients With Acute Myeloid Leukaemia
Lymphoid Leukemia A Phase 1 Study of Blinatumomab in Combination With Checkpoint Inhibitor(s) of PD-1 (Nivolumab) or Both PD-1 (Nivolumab) and CTLA-4 (Ipilimumab) in Patients With Poor-Risk, Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia
Leukemia, other A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/ITD AML
Leukemia, not otherwise specified, Leukemia, other A Phase IB/II Study of Venetoclax (ABT-199) in Combination With Liposomal Vincristine in Patients With Relapsed or Refractory T-Cell or B-Cell Acute Lymphoblastic Leukemia
Leukemia, not otherwise specified, Leukemia, other Phase II Study of Adding the Anti-PD-1 Pembrolizumab to Tyrosine Kinase Inhibitors in Patients With Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease
Leukemia, not otherwise specified, Leukemia, other PTQA: A New Paradigm of Transfusion Decision Support for Patients With MDS
Leukemia, other, Myeloid and Monocytic Leukemia A Phase 1b Study Evaluating the Safety and Pharmacokinetics of Venetoclax as a Single-Agent and in Combination With Azacitidine in Subjects With Relapsed/Refractory Myelodysplastic Syndromes
Multiple Myeloma Global Response Assessment by Advanced Imaging and Myeloma Lesion Biopsies During Induction Therapy of Multiple Myeloma with Carfilzomib Lenalidomide Dexamethasone (CRD)
Myeloid and Monocytic Leukemia Phase I, International, Multicentre, Open-label, Non-randomised, Non-comparative Study of Intravenously Administered S64315, a Mcl-1 Inhibitor, in Patients With Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS)
Leukemia, other An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety and Tolerability of DCLL9718S in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or DCLL9718S in Combination With Azacitidine in Patients With Previously Untreated AML Unsuitable for Intensive Induction Chemotherapy
Myeloid and Monocytic Leukemia A Phase 1 Dose-Escalation Study of LAM-003 in Patients With Acute Myeloid Leukemia
Myeloid and Monocytic Leukemia A Phase 1b/2 Study of PCM-075 in Combination With Either Low-Dose Cytarabine or Decitabine in Subjects With Acute Myeloid Leukemia (AML)
Myeloid and Monocytic Leukemia The National Myelodysplastic Syndromes Natural History Study
Myeloid and Monocytic Leukemia A Randomized Phase II Trial to Simultaneously Evaluate Two Schedules of the Histone Deacetylase Inhibitor Entinostat in Combination With 5-Azacytidine (5AC, NSC 102816) in Elderly Patients With Acute Myeloid Leukemia (AML)
Myeloid and Monocytic Leukemia A Phase 1, Open-label, Dose Finding Study of CC-90009 in Subjects With Relapsed, Refractory Acute Myeloid Leukemia
Leukemia, not otherwise specified, Leukemia, other, Myeloid and Monocytic Leukemia A Multicenter, Pivotal Phase 3 Study of Iomab-B Prior to Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia
Leukemia, other A Phase 1b Study of the Anti-PD1 Antibody Pembrolizumab in Combination With the Histone Deacetylase Inhibitor, Entinostat for Treatment of Patients With Myelodysplastic Syndromes After DNA Methyltransferase Inhibitor Therapy Failure

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