Rory Shallis, MD

Dr. Shallis’ research interests focus on the development and application of novel therapies via early phase clinical trials as well as optimization of existing therapies through outcomes research, particularly for patients with myelodysplastic syndromes/neoplasms (MDS) and acute myeloid leukemia (AML). Dr. Shallis has a particular interest in TP53-mutated AML/MDS as well the management of older patients, two populations that are coincident.

Associations

• Malignant Hematology
• Molecular Medicine Program

My background is comprehensive with facets including experience in the basic laboratory setting, a degree in cell biology, and strong training in clinical medicine. My research focuses on the treatment and outcomes of patients with acute leukemias and myeloid malignancies with a particular interest in TP53-mutated AML/MDS as well the treatment older patients, two populations that are coincident. Given my focus on clinical investigation, I have designed, written, and served as primary investigator or Study Chair for several protocols, from first-in-human to NCI-funded investigator-initiated trials. I have served on or engage regularly with the NCI Older AML Working Group, SWOG and the NCI MyeloMATCH initiative for much of these efforts. I aim to lead and further clinical investigation rooted within a strong framework for research sample collection and correlative analyses to inform the next generation of trials to inform effective therapy for older patients with TP53-mutated AML and improved the outcomes for these unfortunate patients. Supplementing my clinical trial investigation are my parallel efforts in leading multicenter collaborative research and performing outcomes research with epidemiology, health economist and public policy colleagues. Much of this research has centered around the exploration and further refinement of the independent prognostic impact of molecular/cytogenetic abnormalities in poor-risk AML/MDS and elucidating the “real world” practice patterns and ultimately disparities and deficiencies for which a remedy can improve patient outcomes. Not only did these efforts yield the most cited contemporary evaluation of the incidence, prevalence, survival and predictors of outcomes for patients with AML, I have conducted several analyses of disease subgroups with robust accounting for relevant covariates to attempt to describe the independent impact of disease and practice features, including older patients with AML/MDS and those with disease harboring TP53 mutations. I continue to perform outcomes and cost-effectiveness research relating to AML/MDS management to progressively improve the patient journey in parallel with the development/application of novel therapeutics.

Clinical Trial 23602
A Phase 1 Study of AUTX-703 in Participants with Relapsed/Refractory Acute Myeloid Leukemia and Myelodysplastic Syndromes
Condition: Malignant Hematology
Intervention: AUTX-703 ()
Status: OPEN (SUSPENDED)

Clinical Trial 23750
Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination with Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients with Untreated NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia
Condition: Malignant Hematology
Intervention: Azacitidine (5-azacitidine); Cytarabine (Cytosine Arabinoside); Daunomycin (daunorubicin); GDC-0199 (Venetoclax); Venetoclax (); Ziftomenib/Placebo (); daunorubicin ()
Status: Open

Clinical Trial 24126
A Phase I/IIa, Open-Label Dose Escalation and Dose Expansion Study of Intravenous GFH009 Single Agent and in Combination with Venetoclax and Azacitidine in Patients with Relapsed/Refractory Hematologic Malignancies and High-Risk Newly Diagnosed AML
Condition: Malignant Hematology
Intervention: Azacitidine (); GDC-0199 (Venetoclax); GFH-009 (); Venetoclax ()
Status: Open

If you believe you are eligible for one of these trials or studies, please call
813-745-6100 or toll-free 1-800-679-0775.

• Shallis RM. Surveying survival: benchmarking acute myeloid leukemia outcomes without transplant. Haematologica. 2026 Sep. Pubmedid: 42687836.
• Zhang TY, Ge AY, Hutchinson L, Higgins AW, Miron PM, Shallis RM, Patel SA. Limited Survival Benefit and High Healthcare Utilization With AML-Directed Therapy in Older Patients With TP53 -Mutated Acute Myeloid Leukemia. Am J Hematol. 2026 Sep.101(9):2475-2480. Pubmedid: 42332361. Pmcid: PMC13428370.
• Drekolias D, Tuz Zahra F, Fileni C, Sallman DA, Mo Q, Chan O, Zhang L, Vincelette ND, Yu X, Sammut R, Moon J, Park J, Umasangtongkul SA, Lledo FM, Razabdouski TN, Cheng CH, Qin D, Mai K, Ball S, Shallis RM, Xie Z, Kuykendall AT, Padron E, Sweet K, Walker AR, Komrokji RS, Lancet JE, Niyongere S, Cluzeau T, Yun S. Prognostic Model Combining Mutational and Cytogenetic Profiles in Acute Myeloid Leukemia Treated with Venetoclax and Hypomethylating Agents. Blood Cancer Discov. 2026 May.7(3):403-413. Pubmedid: 41671569. Pmcid: PMC12967238.
• Aguirre LE, Bewersdorf JP, Liu Y, Shallis RM, Boussi L, Zucenka A, Garciaz S, Bystrom RP, DeAngelo DJ, Stone RM, Luskin MR, Garcia JS, Winer ES, Ling K, Chen EC, Wadleigh M, Berton G, Stein EM, Goldberg AD, Mendez L, Zeidan AM, Sallman DA, Shimony S, Stahl M. Comparative effectiveness of HMA with venetoclax vs intensive chemotherapy in AML with very high-risk cytogenetics. Blood Neoplasia. 2026 May.3(2):100201. Pubmedid: 41859348. Pmcid: PMC12997325.
• Iqbal U, Shallis RM. Mechanistic overview and suggested strategies to overcome BCL-2 inhibitor resistance in TP53-mutated acute myeloid leukemia. Front Cell Dev Biol. 2026 Mar.14:1779094. Pubmedid: 41929632. Pmcid: PMC13038875.
• Ito S, Potnis KC, Ng DQ, Patel KK, Sra M, Shallis RM, Podoltsev NA, Kewan T, Stempel JM, Mendez L, Huntington SF, Stahl M, Zeidan AM, Bewersdorf JP, Goshua G. Cost-effectiveness of frontline eltrombopag with immunosuppressive therapy for severe aplastic anemia. Blood Red Cells Iron. 2026 Jun.2(2). Pubmedid: 42077391. Pmcid: PMC13134686.
• Bewersdorf JP, Kewan T, Lanino L, Wei W, Rudra Gupta T, Stempel JM, Al Ali NH, DeZern AE, Sekeres MA, Uy GL, Urrutia S, Carraway HE, Desai P, Griffiths EA, Stein EM, Brunner AM, McMahon C, Shallis RM, Zeidner JF, Savona MR, Hawkins H, Chandhok NS, Logothetis CN, Bidikian A, Getz TM, Roboz GJ, Rolles B, Wang ES, Harris AC, Amaya ML, Ball S, Grenet J, Xie Z, Madanat YF, Abaza Y, Badar T, Campos J, Haferlach T, Maciejewski JP, Sallman D, Enjeti A, Al-Rabi K, Halahleh K, Hiwase D, Diez-Campelo M, Valcarcel D, Haferlach C, Pleyer L, Kotsianidis I, Pappa V, Santini V, Consagra A, Al-Kali A, Ogawa S, Nannya Y, Stahl M, Della Porta MG, Komrokji RS, Zeidan AM. Outcomes of patients with higher-risk myelodysplastic syndromes/neoplasms treated with hypomethylating agents + venetoclax-an analysis from the International Consortium for MDS (icMDS) VALIDATE database. Blood Cancer J. 2026 Jun. Pubmedid: 42373605.
• Boussi L, Bewersdorf JP, Liu Y, Shallis RM, Aguirre LE, Bystrom RP, Zucenka A, Garciaz S, DeAngelo DJ, Stone RM, Luskin MR, Garcia JS, Winer ES, Chen EC, Wadleigh M, Berton G, Ling K, Zeidan AM, Stein EM, Shimony S, Goldberg AD, Stahl M. Hypomethylating agents plus venetoclax versus intensive chemotherapy in acute myeloid leukemia with chromosome 5 and 7 abnormalities. Haematologica. 2026 Jul.111(7):2342-2352. Pubmedid: 41609030. Pmcid: PMC13317872.
• Joshi U, Zahra FT, Patel P, Al Ali N, Thompson Z, Pakasticali N, Song J, Agrawal V, Shallis R, Xie Z, Yun S, Kuykendall A, Padron E, Walker A, Sallman D, Komrokji R, Lancet J, Hussaini M, Chan O. Impact of race on mutational profile and survival in acute myeloid leukemia: a single-institution experience (2014-2024). Ann Hematol. 2026 Jul. Pubmedid: 42393270.
• Iqbal U, Fadul J, Sallman DA, Shallis RM. Menin inhibitors for adult acute myeloid leukemia: 2025 update. Expert Opin Inv Drug. 2026 Jan.35(1):37-48. Pubmedid: 41474933.
• Joshi U, Shallis RM. Menin Inhibition in Acute Myeloid Leukemia: Pathobiology, Progress and Promise. Biomedicines. 2026 Jan.14(1). Pubmedid: 41595753. Pmcid: PMC12838656.
• Hunter CJ, Im AP, Shallis RM. Marrow Microenvironmental Pathobiology and Therapeutic Opportunities for TP53-Mutated Myelodysplastic Syndrome/Acute Myeloid Leukemia. Cancers (Basel). 2026 Jan.18(2). Pubmedid: 41595195. Pmcid: PMC12838703.
• Komrokji RS, Komrokji Z, Al Ali NH, Xie Z, Chan O, Kuykendall AT, Walker AR, Yun S, Reynolds SB, Shallis R, Lancet JE, Sallman DA, Padron E. CMML is in the eye of the be-WHO-lder: interrogating the newly proposed entity of oligomonocytic CMML: MDS or CMML?. Blood Neoplasia. 2026 Aug.3(3):100224. Pubmedid: 42232990. Pmcid: PMC13223902.
• Rolles B, Bewersdorf JP, Kewan T, Blaha O, Stempel JM, Lanino L, Al Ali NH, DeZern AE, Sekeres MA, Uy GL, Urrutia S, Carraway HE, Desai P, Griffiths EA, Stein EM, Brunner AM, McMahon C, Shallis RM, Zeidner JF, Savona MR, Barua S, Chandhok NS, Logothetis C, Bidikian A, Getz TM, Roboz GJ, Wang ES, Harris AC, Amaya ML, Hawkins H, Ball S, Grenet J, Abedi P, Shimony S, Lindsley RC, Xie Z, Madanat YF, Abaza Y, Badar T, Haferlach T, Maciejewski JP, Sallman D, Enjeti A, Al-Rabi K, Halahleh K, Hiwase D, Diez-Campelo M, Valcarcel D, Haferlach C, Pleyer L, Kotsianidis I, Pappa V, Santini V, Consagra A, Al-Kali A, Ogawa S, Nannya Y, Porta MGD, Komrokji RS, Zeidan AM, Stahl M. Impact of Response to Hypomethylating Agent-Based Therapy on Survival Outcomes in the Context of Baseline Clinical-Molecular Risk and Transplant Status in Patients With Higher-Risk Myelodysplastic Syndromes/Neoplasms: An analysis From the International Co. Am J Hematol. 2026 Aug. Pubmedid: 42657925.
• Berton G, Bewersdorf JP, Gilhodes J, Iat A, Soua A, DeAngelo DJ, Boussi L, Shallis RM, Žučenka A, Bystrom RP, Ling K, Aguirre LE, Stone RM, Luskin MR, Garcia JS, Winer ES, Chen EC, Wadleigh M, Mendez L, Podoltsev N, Tauveron-Jalenques U, Lanino L, Stein E, Zeidan AM, Forcade E, Cluzeau T, Dumas PY, Heiblig M, Devillier R, Shimony S, Goldberg AD, Stahl M, Garciaz S. Hypomethylating agents plus venetoclax versus intensive chemotherapy prior to transplant in high-risk acute myeloid leukemia. Haematologica. 2026 Apr. Pubmedid: 41924924.
• Joshi U, Shallis RM. MECOM-Rearranged Acute Myeloid Leukemia: Pathobiology and Management Strategies. Hematol Rep. 2025 Oct.17(6). Pubmedid: 41283235. Pmcid: PMC12642003.
• Wang R, Stempel JM, Shallis RM, Huntington SF, Zeidan AM, Neparidze N, Di M, Bewersdorf JP, Mendez L, Ma X, Podoltsev NA. Second malignancies among older patients with classical myeloproliferative neoplasms treated with ruxolitinib. Blood Neoplasia. 2025 Nov.2(4):100159. Pubmedid: 41216598. Pmcid: PMC12597058.
• Bewersdorf JP, Hasle V, Shallis RM, Thompson E, Lopes de Menezes D, Rose S, Boss I, Mendez L, Podoltsev N, Stahl M, Kewan T, Halene S, Haferlach T, Fox BA, Zeidan AM. Integrated Immune Landscape Analysis of RNA Splicing Factor-Mutant AML and Higher risk MDS Treated with Azacitidine ± Durvalumab. Ther Adv Hematol. 2025 Jun.16. Pubmedid: 40546817. Pmcid: PMC12182606.
• Moseley A, LeBlanc M, Freidlin B, Shallis RM, Zeidan AM, Sallman DA, Erba HP, Little RF, Othus M. Evaluating the impact of stratification on the power and cross-arm balance of randomized phase 2 clinical trials. Clin Trials. 2025 Jun.22(3):361-366. Pubmedid: 39815460. Pmcid: PMC12143638.
• Getz TM, Bewersdorf JP, Kewan T, Stempel JM, Bidikian A, Shallis RM, Stahl M, Zeidan AM. Beyond HMAs: Novel Targets and Therapeutic Approaches. Semin Hematol. 2024 Dec.61(6):358-369. Pubmedid: 39389839.
• Badar T, Narra R, Mims AS, Heckman MG, Shallis RM, Fahad S, Hunter C, Kota V, Othman TA, Jonas B, Desai S, de Camargo Correia GS, Patel A, DuVall AS, Palmisiano N, Curran E, Omer Z, Advani A, Atallah E, Litzow M. Impact of induction regimens intensity and allogeneic stem cell transplantation on survival of patients with Philadelphia chromosome-positive acute lymphoblastic leukemia: A multi-institutional study. Am J Hematol. 2024 Dec.99(12):2388-2391. Pubmedid: 39253997.