Clinical Research Directory

Avera Cancer Sequencing and Analytics Protocol (ASAP)

The purpose of this study is to characterize the breadth of molecular features present in participants receiving care within a large, integrated, community-based healthcare system. Through comprehensive genomic profiling, investigators aim to identify the underlying genomic drivers of premalignant and malignant conditions across a range of disease stages and cancer types. Comprehensive molecular profiling will include somatic tumor testing (tissue and/or blood) using next-generation sequencing. Selected subsets of samples may undergo whole exome and/or whole transcriptome sequencing for research purposes. Pharmacogenomic testing will also be performed to better understand individual variability in medication response and to identify opportunities for optimizing treatment. In addition, participants may optionally provide microbiome samples. To maximize the value of the genomic data, participants who consent to this protocol will have their electronic health records-both retrospective and prospective-abstracted, curated, annotated, and linked to the genomic data generated through study testing. Given the long-term value of these data, participants may also voluntarily consent to the storage of their biological samples in a biobank and to the use of their de-identified information for future research. Data collected from this participant population will support efforts to advance the understanding of cancer biology, as well as the discovery and validation of biomarkers associated with clinical outcomes. Findings may also be shared through collaborative research initiatives to further promote advancements in cancer research.

Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies

Non-Hodgkin's lymphoma (NHL) is a cancer that arises from the transformation of normal B and T lymphocytes (white blood cells). The purpose of this study is to assess the safety, pharmacokinetics, and preliminary efficacy of ABBV-101 in adult participants in relapsed or refractory (R/R) non-Hodgkin's lymphomas: chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), diffuse large b-cell lymphoma (DLBCL), non-germinal center B cell (GCB) DLBCL, mantle cell lymphoma (MCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), Waldenström macroglobulinemia (WM), or transformed indolent NHL. Adverse events will be assessed. ABBV-101 is an investigational drug being developed for the treatment of NHL. This study will include a dose escalation phase to determine the maximum administered dose (MAD)/Maximum tolerated dose (MTD) of ABBV-101 and a dose expansion phase to determine the change in disease activity in participants with first line treatment (1L), second line or later of treatment (2L)+ CLL/SLL or third line or later of treatment (3L) non-GCB DLBCL. Approximately 340 adult participants with multiple NHL subtypes will be enrolled in the study in sites world wide. In the Dose Escalation phase of the study participants will receive escalating oral doses of ABBV-101, until the MAD/MTD is determined, as part of the approximately 88 month study duration. In the dose expansion phase of the study participants receive oral ABBV-101, as part of the approximately 88 month study duration . There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.

Early Detection of Complications During Immunotherapy for Haematological Malignancy

Aims * To identify patients that should remain admitted in hospital for more intense surveillance because of high risk for development of clinical complications * Expand the understanding of the interactions between physiology and immunology for the design of future projects and general knowledge Hypothesis Development of a risk model based on a combination of physiological and immunological parameters can contribute to early detection of patients at risk for clinical complications after anti-cancer treatment.

Non-Pharmacological Interventions for Neurotoxicity in Hematologic Patients Receiving CAR-T Therapy

The goal of this clinical trial is to learn if two non-pharmacological strategies can help reduce neurotoxicity caused by CAR-T cell therapy in adult patients with hematologic cancer, both sexes, aged 18 to 80 years. The strategies are: * A structured physical activity program. * A combination of physical activity and nutritional recommendations. The main questions it aims to answer are: * Does physical activity help lower the risk or severity of neurotoxicity after CAR-T therapy? * Does combining physical activity with nutritional recommendations provide greater protection against neurotoxicity than physical activity alone? Researchers will compare two intervention groups with a control group (no intervention) to see which approach is most effective in reducing neurotoxicity and improving recovery. Participants will be randomly assigned to one of three groups using stratified randomization to ensure balanced clinical and demographic characteristics: * Group A: Structured physical activity program. * Group B: Structured physical activity program combined wuth nutritional recommendations. * Group C: No intervention; used to establish baseline patterns. Participants will be evaluated periodically by study professionals. Comprehensive records of symptoms, health measurements, and relevant lifestyle data will be maintained throughout the study.

The Efficacy and Safety of Stereotactic Radiotherapy Bridging Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Hematological Malignance Patients With Extramedullary Infiltrating

Application of Stereotactic Body Radiotherapy (SBRT) Bridging to Allogeneic Hematopoietic Stem Cell Transplantation in Adult Hematological Malignance Patients with Extramedullary Lesions. This study aims to improve transplantation outcomes with extramedullary lesions. The investigators aim to study the Post-Transplantation Evaluation of Disease-Free Survival, Overall Survival, Treatment-Related Mortality, Cumulative Recurrence Rate, Post-Transplantation Complications, and Safety Data.

Discontinuation Study

An interventional, non-randomised study to assess the risk of progression after discontinuation of maintenance therapy in sustained MRD negative complete remission by flow cytometry MM patients without high-risk features who have completed at least two years of maintenance therapy or who have discontinued maintenance due to side effects. The primary endpoint is to assess the rates of sustained MRD negativity by NGF in the bone marrow at 12 months after discontinuation of maintenance therapy.

The Florida ASCENT Study

The goal of this clinical trial is to adapt, implement, and evaluate MyCarePulse and ASCENT patient navigator to overcome barriers to care among patients with cancer. The main hypotheses it aims to test are: * At the patient level, the intervention will result in higher levels of food security, self- efficacy for dietary behaviors, and higher diet quality than standard care. * At the provider level, the intervention will be feasible, acceptable, appropriate, and able to enhance individualized care for patient wellness. Researchers will compare cancer patients receiving the MyCarePulse and ASCENT patient navigator intervention to those receiving standard care, to see if the intervention improves food security, self-efficacy, and diet quality. Phase 1 Patient Participants will: * Complete the ASCENT Questionnaire, which is comprised of the following: * U.S. Food Security Survey Module (U.S. FSSM) * Patient-Reported Outcomes Measurement Information System (PROMIS-29) * Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool * Be assessed using the Veggie Meter instrument * Participate in two semi-structured interviews Provider Participants will: •Participate in one semi-structured interview Phase 2 Patient Participants will: * Participate in ASCENT patient navigator screenings and consultations * Complete the ASCENT Questionnaire, which comprises the U.S. FSSM, PROMIS-29, and ASA24®

Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation

The primary objective is to assess the safety of the addition of venetoclax to reduced intensity conditioning for HLA-matched and haploidentical combined HSC and kidney transplantation as measured by stable full donor hematopoiesis and absence of CTCAE grade IV or V toxicity attributable to venetoclax.

Precision Physical Exercise for Personalized Onco-Hematology.

Physical exercise, particularly strength training, has become an effective strategy to improve physical function, muscle mass, and quality of life in cancer patients. However, the biological mechanisms underlying these benefits remain poorly understood, especially during active treatment. The PEPOH project (Precision physical Exercise for Personalized Onco-Hematology) proposes a single-center clinical trial conducted at the Fundación del Instituto de Investigación Biomédica de Salamanca (FIBSAL) including five different patient cohorts: lung, colorectal (CRC), and breast cancer, chronic lymphocytic leukemia, and multiple myeloma. Participants will be randomly assigned to either an in-person intervention group, performing a supervised strength training program twice a week for 12 weeks combined with a home-based exercise program, or a control group performing only the home-based program. Biological samples will be collected before and after the intervention for multi-dimensional characterization (Genomics, Transcriptomics, Proteomics and Metabolomics) and systematic integration with parameters of functional capacity, quality of life, psychological well-being, frailty, and body composition. The main objective of the project is to determine biological parameters associated with strength exercise and their relationship with clinical parameters related to prognosis, therapy response and survival. This multi-dimensional approach will enable the detection of exercise adaptation biomarkers and generate knowledge about the mechanisms linking exercise with improved health outcomes in individuals with cancer. PEPOH will contribute to biomedical science and will enhance the comprehensive care of oncohematologic patients by integrating multi-omic and clinical data into a precision exercise model. This project will also contribute to society by offering a cost-effective, safe, and transferable intervention, which increases the overall quality of life.

SURGE: Supporting UnderRepresented Minorities in Genomics-based Cancer Trial Enrollment (Intervention)

SURGE aims to increase equity in clinical trial enrollment by addressing barriers to genomic testing, which is increasingly needed to assess precision clinical trial eligibility and access standard precision therapies. The study is an interventional pilot meant primarily to assess the feasibility of the intervention. The intervention is comprised of a patient navigator, text message questionnaire, and informational video.

Improving Comprehensive Care of Cancer Patients

Cancer survivors have unique healthcare needs, including managing serious late effects, ongoing surveillance, lifestyle modifications to reduce second cancer risk, and psychosocial support. Nearly 70% of survivors have at least one comorbid chronic condition in addition to cancer, which complicates the delivery of quality cancer care. Medically underserved patients, who bear the highest burden of multiple chronic conditions, are at increased risk for poor outcomes during and after cancer treatment. Enhancing communication and collaboration between oncologists and primary care providers (PCPs) could improve health outcomes and care transitions for these patients, who often lack healthcare knowledge and access to supportive care. This study evaluates a novel shared care model for cancer survivors with chronic comorbidities, called OPTIMISE (Oncology-Primary Care Partnership to Improve Comprehensive Survivorship Care), in the largest safety-net healthcare system in Houston, Texas. Three hundred newly diagnosed breast, gastrointestinal, and hematological cancer patients being treated with curative intent and having comorbidities requiring ongoing management will be randomized to either OPTIMISE or Usual Medical Care (UMC). UMC patients will receive cancer treatment directed by their oncologist, a survivorship care plan (SCP) at the end of active treatment, and surveillance visits based on national guidelines. OPTIMISE patients will: 1) have an oncology nurse navigator assigned to their care team at diagnosis to facilitate oncologist-PCP communication; 2) receive coordinated care between their oncologist and PCP throughout cancer treatment and surveillance, facilitated by structured communication and referral processes; 3) receive an SCP that incorporates comorbidity management; and 4) follow a risk-stratified shared care model where some routine oncologist follow-up visits are replaced by PCP visits. Aim 1a evaluates OPTIMISE's impact on patient chronic disease self-management (primary outcome) and quality of life (secondary outcome). Aim 1b explores OPTIMISE's effects on healthcare use and patient unmet needs during and after treatment. Aim 2 examines OPTIMISE's impact on oncologist and PCP attitudes and care coordination. Aim 3 elucidates patient- and system-level factors influencing implementation outcomes. If effective, OPTIMISE could expand to other cancers and enhance care transitions in various medical settings.

Hypnosis: a Path to Appeasement

Hypnosis is a technique allowing the patient to focus his mental attention on a thought or a sensation, with the aim of reducing or modulating the intensity of a negative feeling or an ordeal encountered during the course of treatment. This tool can be used when patients are faced with chronic disorders (pain, anxiety, ...) or iatrogenic effects (nausea, asthenia, ...). The patient is referred to hypnosis care by the doctor, psychologist or paramedics who follow him, when they detect a need. Several scientific studies have shown the effectiveness of hypnosis in improving the quality of life of patients with breast cancer and in reducing pain during invasive procedures. On the other hand, in hematology, no research has measured the evolution of anxiety, over time, in patients receiving hypnotherapy.

An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors

This is a study to explore the phenotypic and transcriptional changes of different cellular components in the tumor following the injection of somatic cell therapy drugs. The second objective is to explore phenotypic and transcriptional changes of different cellular components in blood and bone marrow following injection of somatic cell therapy drugs.Then correlate the phenotypic and transcriptional profile of different tumor, blood and bone marrow immune populations with clinical response and/or toxicity. And to finish this study is designed in order to identify a phenotypic, transcriptional and epigenetic profile of intra-tumoral adoptive cells and correlate this profile with clinical response and/or toxicity.

Intervention for Fatigue in HCT Recipients

The purpose of this study is to assess whether a cognitive-behavioral therapy (CBT) for fatigue intervention is acceptable, feasible, and effective at managing fatigue and improving quality of life for patients following hematopoietic stem cell transplant (HCT).

Photobiomodulation for Oral Mucositis and Functional Impairments During Hematopoietic Stem Cell Transplantation

The goal of this clinical trial is to test the efficacy of laser photobiomodulation in adult hematologic cancer patients undergoing hematopoietic stem cell transplantation (HSCT). The main questions it aims to answer are: • Is photobiomodulation with laser in the oral cavity, compared to standard care, effective in preventing oral mucositis and functional impairments in adult patients receiving HSCT? • What is the level of patient´s acceptability of photobiomodulation with laser in the oral cavity during HSCT? Participants once a day will receive photobiomodulation (diode laser device) in their oral cavity from the first day of transplantation conditioning until third day post-transplant. Researchers will compare with usual care to see if photobiomodulation helps preventing oral mucositis and functional impairment.

Evaluate the Safety and Efficacy for Oral Mucositis Prevention of MIT-001 in Auto HSCT

Evaluate the efficacy and safety for the prevention of oral mucositis and PK of MIT-001 for lymphoma or multiple myeloma patients receiving conditioning chemotherapy for autologous hematopoietic stem cell transplantation(auto-HSCT).

Collection of Sequential Samples From Patients With Malignant Myeloid Hemopathy for the Study of Treatment Resistance

The main objective is to study the genomic, transcriptomic, proteomic epigenomic, metabolomic and immune mechanisms of blasts and microenvironment cells associated with IT resistance through the constitution of a collection associating blood or marrow samples from patients with LA, MDS and MPS marrow samples from patients with LA, MDS and MPS at diagnosis, during treatment and at relapse and relapse and clinical annotations.