Digital Commons Network^™

What’S The Beef With Agriculture? Evaluating The Effectiveness Of An Agricultural Literacy Intervention On Students’ Attitudes And Knowledge Toward Sustainability And Animal Agriculture, Jenny E. Bennett

All Graduate Theses and Dissertations, Fall 2023 to Present

Agricultural literacy is essential for helping individuals understand how food systems impact their daily lives and society. While most research has focused on students’ knowledge, this study addresses the underexplored role of attitudes—critical predictors of behavior—as outcomes of educational interventions. This research analyzed survey data collected before and after an agricultural literacy intervention delivered to high school students in school-based agricultural education (SBAE) programs. The curriculum focused on sustainability in animal agriculture.

Findings from paired samples t-tests showed statistically significant improvements in students' attitudes (from moderately neutral to more positive) and knowledge scores. Further analyses revealed that demographic factors such …

Electrophysiological Markers Of Emotion Dysregulation In Autistic Youth, Rachel G. Mcdonald

Theses, Dissertations and Culminating Projects

Emotion dysregulation (ED) is a transdiagnostic mechanism that is conceptualized as difficultly regulating emotions and deploying appropriate regulation strategies in response to environmental stimuli. Meta-analyses suggest that autistic people, across the lifespan, experience more severe ED as compared to both neurotypical people and those with mental health conditions. Despite elevated risk and evidence linking ED to disruptions in neural mechanisms, no studies to date have examined neural markers of ED in autistic populations. The current project uses multi-method and multi-informant measurement to examine similarities and differences in neural mechanisms of ED in autistic and non-autistic populations. Forty-four youth aged 11—17 …

Regulation Of Icer Degradation And Its Role In Melanoma, Justin Wheelan

Theses, Dissertations and Culminating Projects

Melanoma is the deadliest form of skin cancer, with 100,640 new cases and 8,290 deaths estimated in the United States in 2024. While targeted therapies and immunotherapy have improved patient outcomes, resistance remains a major challenge, necessitating new therapeutic approaches. Approximately 50% of melanomas harbor BRAFⱽ⁶⁰⁰ᴱ mutations, leading to constitutive MAPK pathway activation. Targeted small molecule therapies such as BRAF and MEK inhibitors are available and initially reduce tumor burden, however resistance frequently occurs, likely through many pathways including compensatory activation of cAMP signaling. ICER (Inducible cAMP Early Repressor), a transcriptional repressor of CREB-mediated gene expression, is absent in melanoma …

The Effects Of Different Volume-Load On Sprint And Change Of Direction Performance, Damar K. Bobb

Electronic Theses and Dissertations

This study was designed to compare the effects of two different strength training protocols on sprint and change of direction (COD) performance in recreationally trained athletes. Participants were evaluated on maximal dynamic (1RM squat) and isometric (IMTP) strength, speed (30m sprint), and COD (5-0-5 test). The participants were divided into two groups (Low volume-heavy load group [LV], High volume-moderate load high-intensity endurance (HIE) group [HV]) after initial testing, for a 4-week training intervention using traditional and weightlifting derivative lifts. The training consisted of 5 sessions per week (3 sessions resistance training [RT], each about 40-50 mins; 2 sessions sprint & …

Isolation And Characterization Of Siderophore(S) From Pseudomonas Mosselii, Casey J. Stophel

Electronic Theses and Dissertations

Iron is essential for growth of most microorganisms. It functions as an important cofactor in many important biological processes. However, iron found in soil is rendered insoluble and unavailable to microorganisms for use. To overcome this, many bacterial species produce siderophores, a small organic molecule that has high affinity for iron. Siderophores allow for bacterial cells to obtain otherwise insoluble iron. Pseudomonas mosselii, a Gram negative bacterium, was isolated from a local soil sample. P. mosselii was found to produce siderophore(s) under iron restricted environment, however, they have not been characterized. Therefore, it was of interest to isolate, purify and …

Orchestrated Architecture Dismantling: Borrelia Burgdorferi’S Coordinated Destruction Of Adaptive Immune Responses, Craig A. Land

Electronic Theses and Dissertations

Borrelia burgdorferi represents the most prevalent vector-borne bacteria in North America, affecting ~476,000 Americans annually yet persisting despite robust immune responses. This project reveals spirochetes target adaptive immunity through coordinated lymphatic colonization and precision immune dysregulation.

Using comparative host models (C57BL/6 vs. reservoir Peromyscus leucopus), we demonstrate lymph node colonization within 48-hours, with spirochetes exploiting LYVE-1-positive lymphatic structures as dissemination highways while avoiding the interior of follicular regions. Critically, we identify targeted CD4+ T-cell elimination in germinal center border zones at 21-DPI, precisely when these cells should be coordinating protective immunity. Concurrent upregulation of inhibitory receptor CD32b creates molecular …

Improved Autofluorescence Lifetime Decay Analysis For Identification Of Cellular Autofluorescence Biomarkers For Label-Free, Single-Cell Assessment Of Mitochondrial Membrane Potential, Olivia Isabel Kolenc

Graduate Theses and Dissertations

Optical imaging of metabolism using the autofluorescence of the metabolic cofactors NADH, NADPH, and FAD has a wide range of sensitivities and the capability to collect a great deal of metabolic information. Multiphoton microscopy (MPM) is a non-invasive, label-free optical imaging technique capable of performing fluorescence lifetime imaging (FLIM) using time correlated single photon counting (TCSPC). However, autofluorescence FLIM presents a challenge in collecting sufficient photons to provide adequate signal to noise ratios (SNR) for analysis. Additionally, the specificity of autofluorescence biomarkers of metabolism has not been well-defined. Contextualizing these autofluorescence measures using established functional biomarkers can improve interpretability of …

Host-Virus Interaction Dynamics Using Sulfolobus Spindle-Shaped Virus And Host Sulfolobales System, Yeasin Ahmed

Graduate Theses and Dissertations

The Sulfolobus Spindle-shaped virus (SSV) is among the most studied archaeal viruses, particularly in extreme environments. This virus predominantly infects multiple Crenarchaea from the Sulfolobaceae family. These hosts thrive in extreme environmental conditions, such as sulfuric hot springs, with a pH of 2 to 4 and a temperature of 76-80˚C. Sulfolobales exhibit a wide geographical distribution across volcanic hot springs. The Sulfolobus Spindle-shaped Virus (SSV), encompassing strains such as SSV1 and SSV8, employs a non-lytic replication strategy in hosts belonging to the order Sulfolobales. The SSV-Sulfolobales system can be cultured in liquid and gellan gum solid media. A comprehensive study …

Examining The Use Of Two-Dimensional Video Capture And A Pressure Sensing Walkway For Collection Of Obstacle Crossing Measures, Ashlyn M. Jendro

Graduate Theses and Dissertations

Obstacle crossing research is crucial for providing insights into how and why people trip and fall. However, a growing body of literature has proposed that laboratory-based studies may not directly translate into real-world settings due to the complex nature beyond the sterile lab. Unfortunately, the absence of real-world obstacle crossing literature is likely due to a lack of available validated methods for collection of data outside the laboratory. This dissertation explored two potential methodologies (i.e., 2D motion capture and a pressure sensing walkway) that are more portable and cost-effective for collecting real-world obstacle crossing measures. It is hypothesized that 2D …

Freezing And Shipping Optimization To Increase Quality And Profitability Of Meat E-Commerce, Paul Olaoluwaniyi Dahunsi

Graduate Theses and Dissertations

Freezing remains one of the most reliable methods for preserving meat quality and extending shelf life. However, quality deterioration can still occur due to structural and biochemical changes activated during freezing, thawing, and distribution. Since the COVID-19 pandemic, consumers’ preference for bulk purchasing and online meat shopping has increased, raising questions about the best strategies to balance both quality maintenance and profitability. This thesis aimed to evaluate two key stages where frozen beef is most vulnerable to quality degradation: consumer-level freezing and post-purchase shipping. The objectives were (1) to determine the effects of product size and subsequent consumer freezing practices …

A Multicomponent Microneedle Patch For The Delivery Of Meloxicam For Veterinary Applications, Katherine Alejandra Miranda Munoz

Graduate Theses and Dissertations

Veterinary medicine requires innovative drug delivery strategies to enhance therapeutic efficacy while minimizing stress and handling. This dissertation explores the development and application of biodegradable microneedle patches for the transdermal delivery of meloxicam in livestock, offering a minimally invasive alternative to traditional administration methods. The research investigates the fabrication and characterization of microneedles using polyvinyl alcohol, collagen, and chitosan blends, demonstrating their mechanical strength, biocompatibility, and ability to facilitate sustained drug release. In vitro and in vivo evaluations confirm effective skin penetration, dissolution, and localized drug delivery. Pharmacokinetic studies highlight anatomical site-dependent variations in drug absorption, emphasizing the need for …

Small Angle X-Ray Scattering Studies Of Collagenase H Mutant, Colh-E416q, Madelyn Millsap

Graduate Theses and Dissertations

Collagenase H (ColH) from Hathewaya histolytica plays a central role in collagen degradation through endopeptidase and carboxytripeptidase reactions. To better understand how its domain architecture supports these functions, we examined the solution structure of a catalytically inactive mutant, ColH-E416Q, using small-angle X-ray scattering (SAXS). The E416Q mutant is catalytically inactive because the glutamate residue at position 416, which normally functions as a general acid/base during catalysis, is replaced by glutamine—an amide that cannot donate or accept protons effectively, thus disabling the proton transfer steps essential for peptide bond hydrolysis. SAXS results indicate that the E416Q substitution leaves overall domain architecture …

Effect Of Dietary Tryptophan Supplementation And Heat Stress On Pasture Broiler Welfare And Performance, Jaelen Matthew Cherry

Graduate Theses and Dissertations

Pasture-raised broiler chickens face temperature extremes that can threaten welfare. In the study, we evaluated whether a 0.26 % tryptophan-supplemented diet (T) improved heat stress (HS) resilience in Ross-708 broilers raised on pasture. At D14, birds began the T or remained on the control diet (C) and were moved outdoors. On D20 and 41, half of each group underwent six-hour HS; the remainder stayed under thermoneutral (TN) conditions. Weekly body weight, feed intake on D20 and D41 were recorded, and fear was measured using the Tonic Immobility (TI) test. Neither diet nor HS affected body weight. However, tryptophan supplementation resulted …

Modeling U.S. Corn Production Archetypes In The Agricultural Policy/Environmental Extender Model To Generate Life Cycle Assessment Inventory Data, Brandon Taylor

Graduate Theses and Dissertations

Corn (Zea mays) is an important crop grown across the US for many uses such as grain for animal feed, bio-ethanol production, food products, and industrial products. Corn is produced in almost every state in the US, but most corn production is concentrated in the Corn Belt Region including Iowa, Illinois, Ohio, Indiana, Minnesota, and Nebraska. Although technologies and production practices are improving corn production efficiency primarily through increased yields (improved land use), corn production at this scale greatly impacts the environment through emissions from fertilizer and pesticide runoff and leaching, soil degradation due to improper field practices, as well …

Advanced Analytical Biosensing For Cancer Detection And Neural Diagnostics Using Tapered Optical Fiber (Tof), Protonic, And High Throughput Microplate –Based Technologie, Bayan Hassan Alharbi

Chemistry & Biochemistry Theses & Dissertations

This dissertation investigates the development and application of advanced biosensing technologies to enhance early disease detection, neurological diagnostics, and bioactive compound evaluation. The research spans four key areas. First, it introduces tapered optical fiber (TOF)-based plasmonic biosensors for the non-invasive detection of prostate cancer, demonstrating high sensitivity and specificity compared to conventional diagnostic methods.

Second, it explores the use of fluorescent biosensors to test the Transmembrane Electrostatically Localized Proton (TELP) theory, shedding light on the role of localized protons in neuronal signaling and energy transfer. Third, the work presents a high-throughput, microplate-based biosensing platform for analyzing mitochondrial function under nanosecond …

Multi-Crop Systems And Crop-Switching Strategies To Enhance Water Use Efficiency And Climate Resilience In Arid Agricultural Regions, Shahryar Fazli, Wenzhao Li, Surendra Maharjan, Hesham El-Askary

Mathematics, Physics, and Computer Science Faculty Articles and Research

Agriculture in the Lower Colorado River (LCR) region faces mounting challenges from climate change, arid conditions, and water scarcity. This study evaluates water use efficiency (WUEc) and crop-switching strategies under SSP2-4.5 and SSP5-8.5 scenarios for 2025–2049, 2050–2074, and 2075–2099. Using historical data, climatic drivers such as temperature and precipitation were analyzed for their influence on key crops, including durum wheat, winter wheat, and corn. Results show SSP2-4.5 supports water use reductions up to 16%, stable profits (80–90%), and modest calorie increases (up to 15%), while SSP5-8.5 poses severe challenges, with water use reductions of 2–5%, profits dropping to around 20%, …

A Simple Guide For Describing Soils, 2nd Edition, Angela Stuart-Street, Nicolyn Short Dr, Paul Galloway, Noel R. Schoknecht

Natural resources published reports

Soils are enormously diverse and can be very confusing to understand and talk about. This simple guide for describing soils helps to identify the most important parts of a soil profile and provide an easy way to understand and explain what you see. It gives you a step-by-step guide of what soil properties to describe and how to describe them, along with the tools to make basic soil classifications. The soil descriptors help you to identify the soil type and aid in assigning a simple and standardised name to the soil. While this guide is designed to link with a …

Stress-Survival Pathway Genes In Colorectal Cancer: Crc Progression And Hispanic Disparities, Highlighting Mcm10 As A Potential Player, Urbashi Basnet

Open Access Theses & Dissertations

Despite advances in screening and treatment, colorectal cancer (CRC) remains a leading cause of cancer-related deaths in the U.S., with notable disparities across racial and ethnic groups. Hispanic populations face a disproportionate burden, underscoring significant differences in incidence and outcomes. This study examines the role of the Stress-Survival Pathway (SSP) in colorectal cancer (CRC), with a focus on addressing health disparities among Hispanic populations. Twenty-eight differentially expressed SSP genes identified from bioinformatic analysis were validated in CRC cell lines and cDNA arrays using qRT-PCR and tissue microarrays by immunohistochemistry. SSP genes were further analyzed in CRC tissues from Hispanic and …

Investigating The E74-Mediated Regulation Of A Gata Factor In Aedes Aegypti Mosquitoes, Jacklyn Marie Estrada

Open Access Theses & Dissertations

The mosquito species Aedes aegypti has a significant impact on public health as a vector for multiple pathogens. Its ability to transmit deadly diseases, including Yellow Fever, Dengue Fever, and Zika, emphasizes the urgency of understanding its reproductive biology. In female mosquitoes, reproductive success hinges on obtaining a vertebrate blood meal, which triggers vitellogenesis - the synthesis of yolk protein precursors (YPPs) necessary for egg development. Without a blood meal, female Ae. aegypti remain in a state of previtellogenic arrest, where the YPP gene vitellogenin (Vg) is repressed by a type of transcriptional factor, GATAr (AaGATAr) (Attardo et al., 2003). …

The Feasibility And Impact Of Self-Administered Neuromuscular Electrical Stimulation On Glycemic Control In Hyperglycemia Population- A Pilot Study, Zahra Fatahimeiabadi

Open Access Theses & Dissertations

Introduction: Neuromuscular electrical stimulation (NMES) has shown promise in improving glycemic outcomes in supervised, laboratory-based settings. However, its feasibility and effectiveness in real-world, community-based applications remain underexplored, particularly among sedentary, overweight/obese individuals at risk for type 2 diabetes (T2D). This study aims to assess the feasibility and effectiveness of self-administered NMES use on glycemic control and substrate utilization among sedentary, overweight/obese population with hyperglycemia. Methods: Ten participants (N=10 [Males:4; Females:6] Age: 38.9 ± 14.1 years; BMI: 36.0 ± 8.7 kg/m2) sedentary Overweight/obese participants with hyperglycemia were randomized to either an NMES or control group and were trained and instructed to …

Spatial And Thermal Aspects Of The Ecology Of Three Sympatric Rattlesnakes In The Montane Northern Chihuahuan Desert, Joshua James Mead

Open Access Theses & Dissertations

To understand how animals coexist on the landscape, the individual aspects of a species life history must first be understood. Animals need to find locations that provide the resources they need to survive. Movement, microhabitats, and temperature can alter such areas where animals occur. Understanding animal movements provide important information on space use and microhabitats on the landscape. Ectothermic animals must acquiesce to ambient temperatures or use behavioral modifications to alter their body temperature. The ability to maintain suitable body temperature is essential for physiological function, reproduction, and ability to avoid predation. Research on the variation in a species ecology …

Systematics Of African River Frogs (Anura: Pyxicephalidae: Amietia) In Central Africa, With The Description Of Two New Species, Jesus Manuel Reyes

Open Access Theses & Dissertations

Amietia is a pyxicephalid anuran genus that is prevalent throughout central, southern, and eastern portions of sub-Saharan Africa. Recent phylogenetic studies have been in conflict regarding the validity and composition of several Amietia species in the Albertine Rift region. The goals of this study are to: (1) generate an updated molecular phylogeny for Central African Amietia with new sampling; (2) clarify the relationship between the previously unsampled taxa A. amieti and A. chapini; (3) clarify the status of A. desaegeri; and (4) confirm the taxonomic status of potentially new species. Maximum likelihood and Bayesian inference methods were used to generate …

Phylogenetics And Integrative Taxonomy Of The Lang's Reed Frog Species Complex (Anura: Hyperoliidae: Hyperolius Langi), Dominic Troiani

Open Access Theses & Dissertations

The genus Hyperolius (Rapp, 1842) is the most speciose amphibian genus in sub-Saharan Africa. The genus has a complex taxonomic history because of its extensive intraspecific and interspecific morphological variation, large geographic distribution of many taxa, gaps in sampling, and the discovery of significant cryptic diversity within many species. The goal of this study is to understand the relationships and taxonomy of Hyperolius langi via an integrative taxonomic approach that combines molecular, morphological, and bioacoustics data to clarify the systematics of the geographically widespread species Hyperolius langi. Two mitochondrial (16S and cyt b) and one nuclear (RAG1) gene were used …

Isolation And Functional Properties Of Highly-Purified N-Terminal Domain Of Human Napi2b By Scalable “Resin Overload” Technique, Daria Savenkova, Irina Makarenko, Daria Nedorezova, Ramziya Kiyamova, Mikhail Bogdanov

Faculty, Staff and Student Publications

Despite the enthusiasm and advances in the purification of native and engineered full-length membrane proteins, little attention has been paid to their fragments which could serve as attractive inspiration for function, regulation, or targeting of full-length membrane protein with therapeutic antibodies (Abs). Production of recombinant fragments of "therapeutic" membrane proteins for early-stage discovery research requires their purification to near homogeneity. It is important not only for the production of biotherapeutic antibodies but also for structural and functional studies of competitive protein-Abs, protein-protein, and lipid-protein interactions which heavily rely on the purity and quality of the isolated protein fragment of interest. …

Perioperative Durvalumab Plus Chemotherapy Plus New Agents For Resectable Non-Small-Cell Lung Cancer: The Platform Phase 2 Neocoast-2 Trial, Tina Cascone, Laura Bonanno, Florian Guisier, Amelia Insa, Moishe Liberman, Olivier Bylicki, Lorenzo Livi, Thomas Egenod, Romain Corre, Dong-Wan Kim, Maria Rosario Garcia Campelo, Mariano Provencio Pulla, Byoung Yong Shim, Giulio Metro, Jaafar Bennouna, Agata A Bielska, Alula R Yohannes, Yun He, Adam Dowson, Gozde Kar, Lara Mcgrath, Rakesh Kumar, Italia Grenga, Jonathan Spicer, Patrick M Forde

Faculty, Staff and Student Publications

In the phase II NeoCOAST-2 platform study, 202 patients with untreated, resectable stage IIA–IIIB non-small-cell lung cancer (NSCLC) were randomized to receive neoadjuvant durvalumab plus platinum-doublet chemotherapy with oleclumab, a CD73 inhibitor (Arm 1), or with monalizumab, a NKG2A inhibitor (Arm 2), or neoadjuvant durvalumab plus single-agent platinum chemotherapy with the TROP-2 antibody–drug conjugate (ADC) datopotamab deruxtecan (Arm 4), followed by surgical resection and adjuvant durvalumab with oleclumab or monalizumab (Arms 1 and 2) or durvalumab alone (Arm 4). Primary endpoints were pathological complete response (pCR) rate and safety; secondary endpoints included feasibility of surgery and major pathological response (mPR) …

2025 European Leukemianet Recommendations For The Management Of Chronic Myeloid Leukemia, Jane F Apperley, Dragana Milojkovic, Nicholas C P Cross, Henrik Hjorth-Hansen, Andreas Hochhaus, Hagop Kantarjian, Jeffrey H Lipton, Hemant Malhotra, Dietger Niederwieser, Jerald Radich, Philippe Rousselot, Susanne Saussele, Charles A Schiffer, Richard Silver, Simona Soverini, Leif Stenke, Anna Turkina, Luis Felipe Casado, Fausto Castagnetti, Francisco Cervantes, Richard E Clark, Jorge Cortes, Michael Deininger, Timothy P Hughes, Jeroen Janssen, Qian Jiang, Dong-Wook Kim, Richard A Larson, Francois X Mahon, Michael Mauro, Jiri Mayer, Franck E Nicolini, Fabrizio Pane, Delphine Rea, Johan Richter, Gianantonio Rosti, Giuseppe Saglio, Rüdiger Hehlmann

Faculty, Staff and Student Publications

In this 5th version of the European LeukemiaNet guidance for adult patients, there are important changes in several areas of management based on evidence available since 2020, including the World Health Organisation's reclassification of CML as a biphasic disease. Previous advice to switch the tyrosine kinase inhibitor (TKI) on failure of molecular milestones, is modified to better account for individual patient circumstances. Our recommendations are summarized in tables designed to be read in conjunction with the text which offers justification and additional advice. We describe decision-making for first-line treatment, both in available drugs and their initial dosing. Similarly we elaborate …

Addressing Challenges In Developing Treatments For Inherited Retinal Diseases: Recommendations From The Third Monaciano Symposium, Debra A Thompson, K Thiran Jayasundera, Oleg Alekseev, Robin R Ali, Alessia Amato, Vadim Y Arshavsky, Isabelle S Audo, Alberto Auricchio, James W B Bainbridge, Eyal Banin, Cagri G Besirli, David G Birch, Kari E Branham, Artur V Cideciyan, Stephen P Daiger, Jacque L Duncan, Abigail T Fahim, John G Flannery, Roberto Gattegna, John R Heckenlively, Elise Héon, Alessandro Iannaccone, Naheed W Khan, Samer Khateb, Henry J Klassen, Bart P Leroy, Dario Marangoni, Michel Michaelides, David C Musch, Mark E Pennesi, Simon M Petersen-Jones, Eric A Pierce, Rajesh C Rao, José-Alain Sahel, Paul A Sieving, Enrica Strettoi, Cameron R Strong, Thomas J Wubben, Paul Yang, David N Zacks

Faculty, Staff and Student Publications

Over the past decade, efforts focused on developing genetic therapies for inherited retinal diseases have advanced steadily to clinical trials and the development of a treatment, fueling optimism for the potential of precision medicines to provide safe and effective therapies for these rare conditions. Although several ongoing programs remain poised for success, numerous challenges have negatively impacted the ability to obtain regulatory approvals. The present position paper briefly summarizes recent advances and challenges in developing therapeutics for inherited retinal diseases, and presents a set of recommendations for moving the field forward. The priorities identified are discussed in terms of progress …

A Phase 2 Trial Of Cpx-351 Combined With Venetoclax In Relapsed Or Refractory Acute Myeloid Leukemia, Tapan M Kadia, Wei-Ying Jen, Alex Bataller, Alexandre Bazinet, Gautam Borthakur, Elias Jabbour, Wei Qiao, Nicholas J Short, Koichi Takahashi, Ghayas C Issa, Courtney D Dinardo, Guillermo Montalban-Bravo, Naveen Pemmaraju, Andrew Tran, Vanthana Bharathi, Sanam Loghavi, Amin M Alousi, Uday Popat, Naval G Daver, Farhad Ravandi, Hagop M Kantarjian

Faculty, Staff and Student Publications

Outcomes in patients with relapsed/refractory (RR) AML are poor. We sought to investigate if CPX-531 in combination with venetoclax (CPX + VEN) was tolerable and effective in RR AML. This was a single institution phase 1b/2 trial of CPX + VEN. Patients aged ≥ 18 years with RR AML who were fit for intensive chemotherapy were eligible. Prior venetoclax exposure was allowed. The phase 1b portion followed a 3 + 3 design to identify the recommended phase 2 dose (RP2D) for the expansion cohort. At the starting dose level of −1, prolonged myelosuppression was observed, leading to dose level −2 …

Efficacy And Safety Of Oral Decitabine/Cedazuridine In The Chronic Myelomonocytic Leukaemia Subpopulations From Phase 2 And 3 Studies, Michael R Savona, Olatoyosi Odenike, Gail J Roboz, Harshad Amin, Amy E Dezern, Elizabeth A Griffiths, Kim-Hien Dao, Amer M Zeidan, Bhavana Bhatnagar, Rena Buckstein, Brian Leber, Mary-Margaret Keating, Somedeb Ball, Aram Oganesian, Yuri Sano, Harold N Keer, Guillermo Garcia-Manero

Faculty, Staff and Student Publications

DNA methyltransferase inhibitors (DNMTis) are commonly used in treating chronic myelomonocytic leukaemia (CMML); however, data from prospective studies of DNMTis in CMML are limited. The present analysis evaluated the efficacy, safety and pharmacodynamics of the oral DNMTi decitabine/cedazuridine in the subset of patients with CMML from the phase 2 and 3 trials, which led to the approval of this agent for myelodysplastic syndromes and CMML in the United States and Canada. Potential prognostic factors also were analysed. In all, 34 patients with CMML were screened and 33 were treated. Most patients (76% [n = 25]) had myelodysplastic type-CMML and 77% …

Master Protocol Design With Hybrid Control For Efficient Early-Phase Trial Consolidation, Alexander M Kaizer, Xiaojiang Zhan, Eric Baron, Rui Sammi Tang, David S Hong, Brian P Hobbs

Faculty, Staff and Student Publications

Purpose: Master protocols represent transformations, enabling multiple therapies or diseases under a single protocol. These designs streamline therapeutic development by reducing redundancies. Suited for evolving fields such as oncology and global emergencies such as the COVID-19 pandemic, master protocols have been exemplified by studies such as RECOVERY, Solidarity, and I-SPY 2, which accelerated effective treatment identification (with I-SPY 2 focused on molecular subtypes). Recent oncology examples, such as MORPHEUS, evaluate immunotherapy combinations with shared controls. Despite advantages, their application in early-phase oncology remains underutilized amid growing regulatory emphasis on randomization for robust evidence.

Methods: US Food and Drug Administration (FDA) …