Clinical Research Directory

Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies

This phase II trial studies how well a donor stem cell transplant, treosulfan, fludarabine, and total-body irradiation work in treating patients with blood cancers (hematological malignancies). Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.

Social Health, Activity Behaviors, and Quality of Life Among Young Adult Cancer Survivors

This study assesses how personal relationships (such as friendships, family relationships, or romantic partners) influence the physical activity (exercise) and well-being of young adult cancer survivors. Researchers also hope to learn how social relationships change after a cancer diagnosis, and how these changes might impact important health behaviors. The information provided may help researchers learn more about better ways to support young cancer patients in the future through interventions that help maintain good social relationships and health levels of physical activity.

A Study of Brentuximab Vedotin in Adults With Hodgkin's Lymphoma

The main aim is to check how effective BV is for treating adults with HL. Study medication will be prescribed according to the clinic's standard practice. Participants will visit the study clinic 5 times, once every 12 weeks. When study treatment has completed, a follow-up visit will be scheduled every 3 months during the first year and every 4-6 months during the next year.

Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Favorable-Risk Hodgkin Lymphoma

This phase II trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with favorable-risk Hodgkin lymphoma. Drugs used in chemotherapy, such as doxorubicin hydrochloride, vinblastine, mechlorethamine hydrochloride, vincristine sulfate, bleomycin, etoposide, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses high-energy x-rays to kill cancer cells for those patients that still had residual cancer at the end of chemotherapy. Giving combination chemotherapy with radiation therapy may kill more cancer cells and allow doctors to save the part of the body where the cancer started.

PD-1 Inhibitors Maintenance for cHL Post-autoHCT

This phase II study is designed to determine the clinical efficacy of PD-1 inhibitors, administered as maintenance therapy after autologous stem cell transplant (autoHCT), in patients with relapsed or refractory (R/R) classical Hodgkin Lymphoma (cHL)

Phase 2 Study Of Nivolumab Plus AVD In Pediatric, Adolescent, And Young Adult Patients With CHL

The goal of this clinical research study is to learn if nivolumab plus AVD (doxorubicin, vinblastine, and dacarbazine) can help to control newly diagnosed early-stage non-bulky cHL in pediatric, adolescent, and young adult patients. The safety of this drug combination will also be studied.

A Phase II Trial of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide in Patients With Relapsed B-cell NHL

To learn if giving mosunetuzumab in combination with polatuzumab vedotin, tafasitamab, and lenalidomide can help to control relapsed/refractory FL and DLBCL.

AZD3470 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Haematologic Malignancies.

This study is designed to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy following oral administration of AZD3470 as a monotherapy, and in combination with other anticancer agents in participants with haematologic malignancies.

The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas

This phase II trial studies whether providing cancer treatment in the home is preferred over the traditional clinic setting and if it improves treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas. Typically, drug-related cancer care is provided at a medical center which causes patients to have to spend considerable time away from their family, friends, and familiar surroundings. This may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. The Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) program uses a specialized care team trained to provide cancer treatment in the patient's home setting. It is designed to support remote connection between the home health team and providers and Mayo clinic. This may be preferred over the traditional clinic setting which may improve treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas.

CD45BE-HSPC + CART-45 Cells

This is a phase 1, open-label, dose-finding study to assess the safety, feasibility, pharmacokinetics and preliminary efficacy of autologous base edited anti-CD45 CAR T cells (referred to as "CART-45 cells") following an autologous transplant of CD45 base edited hematopoietic stem and progenitor cells (referred to as "CD45BE-HSPC") in patients with relapsed or refractory hematologic malignancies.

ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies

This study is evaluating the safety, pharmacodynamics (PD), and efficacy of acalabrutinib and pembrolizumab in hematologic malignancies.

Multi-antigen CMV-MVA Triplex Vaccine in Reducing CMV Complications in Patients Previously Infected With CMV and Undergoing Donor Hematopoietic Cell Transplant

This randomized phase II trial studies the safety and how well multi-peptide cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) vaccine works in reducing CMV complications in patients previously infected with CMV and are undergoing a donor hematopoietic cell transplant. CMV is a virus that may reproduce and cause disease and even death in patients with lowered immune systems, such as those undergoing a hematopoietic cell transplant. By placing 3 small pieces of CMV deoxyribonucleic acid (DNA) (the chemical form of genes) into a very safe, weakened virus called MVA, the multi-peptide CMV-MVA vaccine may be able to induce immunity (the ability to recognize and respond to an infection) to CMV. This may help to reduce both CMV complications and reduce the need for antiviral drugs in patients undergoing a donor hematopoietic cell transplant.

Pembrolizumab and Involved Site Radiation Therapy for Early Stage Relapsed or Primary Refractory Hodgkin Lymphoma

This study is being done to test the safety and effectiveness of pembrolizumab followed by radiation therapy in Hodgkin lymphoma. The purpose of this study is to determine how effective combining the research drug, pembrolizumab, with a targeted form of radiation therapy known as involved site radiotherapy can be in patients with relapsed or refractory early stage classical Hodgkin lymphoma. The goal is to see whether this treatment strategy can cure a significant number of patients with relapsed or refractory early stage classical Hodgkin lymphoma while avoiding the toxicity of either a large radiation field or further chemotherapy and stem cell transplant.

Evaluating Combination of Nivolumab and Axatilimab in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

The goal of this clinical trial is to study the combination of nivolumab and axatilimab in patients with relapsed/refractory classical Hodgkin Lymphoma. This study will mainly look at if the combination works as expected.

Phase1 Basket Trial Of CAR.70-Engineered IL15-Transduced With TGFBR2 Knock Out Cord Blood-Derived NK Cells For Relapsed/Refractory Lymphoid Malignancies

This is a phase 1 basket trial of TGFBR2 KO CAR27/IL-15 NK cells after lymphodepleting chemotherapy for patients with R/R B-NHL, HL, T-NHL or B-ALL.

Phase I/II Study of CAR.70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Hematological Malignances

The goal of this clinical research study is to learn about the safety of giving immune cells called natural killer (NK) cells with chemotherapy to patients with leukemia, lymphoma, or multiple myeloma. Immune system cells (such as NK cells) are made by the body to attack foreign or cancerous cells. Researchers think that NK cells you receive from a donor may react against cancer cells in your body, which may help to control the disease.

Phase 2 Trial of CD70.CAR NK Cells for Patients With Primary Refractory or Early Relapsed Diffuse Large B-Cell Lymphoma and Hodgkin Lymphoma

This clinical research study is to learn if CD70.CAR NK cell therapy can help to control early relapsed or primary refractory DLBCL and cHL.

Evaluating the Impact of Social and Genetic Factors on Outcomes in Adolescent and Young Adult Cancer Survivors

This study examines the impact of social and genetic factors on outcomes in adolescent and young adult (AYA) cancer survivors of Hodgkin or non-Hodgkin lymphoma. Compared to both older adult and childhood cancer patients, AYAs with cancer experience different diagnoses and specific biological, clinical, psychological and social factors that affect their risks for post-treatment morbidity and premature death. Collecting samples of blood samples and health and treatment information from cancer survivors of Hodgkin or non-Hodgkin lymphoma may help doctors identify conditions that increase the likelihood of AYAs getting sick and dying after treatment of cancer and better understand how to address the needs of adolescent and young adult cancer survivors.

Genome Expression in Lymphoma, Leukemia and Multiple Myeloma

This study will use genomics-based technology, such as DNA microarrays, to more precisely diagnose subsets of lymphoma, leukemia and multiple myeloma patients. There have been many attempts to classify lymphoid cancers in ways that will be useful for clinical diagnosis and treatment. Although broad diagnostic categories have been reliably defined, patients within each category have distinct clinical courses, suggesting that these classifications could be further divided into molecular (genetic) subtypes. For example, 40 percent of patients with diffuse large B-cell lymphoma achieve long-term disease remissions following combination chemotherapy and are apparently cured, whereas the remaining 60 percent die from the disease. Similarly, some patients with follicular lymphoma develop aggressive disease within a few years of diagnosis, while others have stable disease over 10 to 20 years. Although the distinctions in clinical course of these diseases are recognized, there are no studies to determine the molecular (genetic) basis for this variability. This study will try to define new molecular diagnostic categories in these diseases and correlate them with clinical features, including treatment response, disease remission and overall survival following chemotherapy. This retrospective study will use clinical data and tissue samples from participating centers in the Lymphoma/Leukemia Molecular Profiling Project LLMPP). New patients will not be recruited for this study. Biopsy materials, including fresh frozen or OTC-embedded lymphoma biopsy material, viably frozen samples of peripheral blood cells from leukemia patients, and viably frozen samples of bone marrow aspirates from multiple myeloma patients will be collected from pathologists participating in the LLMPP. RNA and genomic DNA will be extracted from the tumor samples. A variety of technologies will be used to characterize the genome of the cancer cells, including lymphochip microarrays for array-based comparative genomic hybridization; Southern blotting and PCR for translocation of genes previously implicated in these malignancies; and PCR and DNA sequencing methods for analyzing base changes in the genome of the cancer cells. Clinical information from the initial diagnosis to disease relapse will be taken from existing databases and/or patient charts. Gene expression will be correlated with the clinical data. If a small number of genes is found to strongly predict clinical outcome, quantitative RT-PCR assays using the Taqman technology may be developed as an alternative to DNA microarray analysis.

Methionine PET/CT Studies In Patients With Cancer

The purpose of this study is to test the usefulness of imaging with radiolabeled methionine in the evaluation of children and young adults with tumor(s). Methionine is a naturally occurring essential amino acid. It is crucial for the formation of proteins. When labeled with carbon-11 (C-11), a radioactive isotope of the naturally occurring carbon-12, the distribution of methionine can be determined noninvasively using a PET (positron emission tomography) camera. C-11 methionine (MET) has been shown valuable in the monitoring of a large number of neoplasms. Since C-11 has a short half life (20 minutes), MET must be produced in a facility very close to its intended use. Thus, it is not widely available and is produced only at select institutions with access to a cyclotron and PET chemistry facility. With the new availability of short lived tracers produced by its PET chemistry unit, St. Jude Children's Research Hospital (St. Jude) is one of only a few facilities with the capabilities and interests to evaluate the utility of PET scanning in the detection of tumors, evaluation of response to therapy, and distinction of residual tumor from scar tissue in patients who have completed therapy. The investigators propose to examine the biodistribution of MET in patients with malignant solid neoplasms, with emphasis on central nervous system (CNS) tumors and sarcomas. This project introduces a new diagnostic test for the noninvasive evaluation of neoplasms in pediatric oncology. Although not the primary purpose of this proposal, the investigators anticipate that MET studies will provide useful clinical information for the management of patients with malignant neoplasms.

A Longitudinal Assessment of Frailty in Young Adult Survivors of Childhood Cancer

Advances in cancer therapies have led to increasing numbers of adult survivors of pediatric malignancy. Unfortunately, treatment of childhood cancer continues to require agents designed to destroy malignant cell lines, and normal tissue is not always spared. While early treatment- related organ specific toxicities are not always apparent, many childhood cancer survivors report symptoms that interfere with daily life, including exercise induced shortness of breath, fatigue and reduced capacity to participate in physical activity. These symptoms may be a hallmark of premature aging, or frailty. Frailty is a phenotype most commonly described in older adults; it indicates persons who are highly vulnerable to adverse health outcomes. Frailty may help explain why nearly two thirds of childhood cancer survivors have at least one severe chronic health condition 30 years from diagnosis, why childhood cancer survivors are more likely than peers to be hospitalized for non-obstetrical reasons, and why they have mortality rates more than eight times higher than age-and-gender matched members of the general population. Frailty is a valuable construct because it can be distinguished from disability and co-morbidity, and is designed to capture pre-clinical states of physiologic vulnerability that identify individuals most at risk for adverse health outcomes. These investigators have recently presented data indicating that impaired fitness is present in survivors of childhood acute lymphoblastic leukemia, brain tumor and Hodgkin lymphoma. This is relevant because frailty, characterized by a cluster of five measurements of physical fitness, is predictive of chronic disease onset, frequent hospitalization, and eventually mortality in both the elderly and in persons with chronic conditions. Using a frailty phenotype as an early predictor of later chronic disease onset will allow identification of childhood and adolescent cancer survivors at greatest risk for adverse health. An early indicator of those at risk for adverse health will allow researchers to test, and clinicians to provide, specific interventions designed to remediate functional loss, and prevent or delay onset of chronic health conditions. The investigators goals include characterizing physical frailty over a five year time span in a population of young adult survivors of childhood cancer, as well as assessing the association between frailty and the increase in the number and severity of chronic health conditions.

A Study of BV-AVD in People With Bulky Hodgkin Lymphoma

The purpose of this study is to test whether BV-AVD is an effective treatment in people with early stage, bulky Hodgkin lymphoma that was recently diagnosed and who have not yet received any treatments for their disease. BV is a type of drug called an antibody-drug conjugate (ADC). ADCs are a substance made up of a monoclonal antibody chemically linked to a drug. Antibodies are proteins made by the immune system to fight infections and other possible harms to the body. The monoclonal antibody binds to specific proteins or receptors found on certain types of cells, including cancer cells. The linked drug enters these cells and kills them without harming other cells. Researchers think BV may be an effective treatment for this type of cancer because the drug targets cells that have CD30, which play a role in cancer cell growth. By destroying these cells, BV may help slow or stop the growth of the cancer. AVD (doxorubicin, vinblastine, and dacarbazine) is a treatment regimen that works by stopping the growth of cancer cells, either by killing the cells or by stopping them from dividing. The researchers think that BV in combination with AVD may work better than AVD alone to slow or stop the growth of the cancer.

Integration of Adaptive Proton Therapy in Pediatric Solid Tumors and Hodgkin's Lymphoma

Pediatric patients receiving proton therapy for solid tumors or Hodgkin's lymphoma may experience anatomical changes during treatment that can affect proton therapy accuracy. This prospective single-arm study uses regular low-dose imaging to monitor these changes and adjust treatment plans as needed. Participants will receive weekly or every-other-week CT scans, with MRI when appropriate, to assess whether the original plan remains accurate. Treatment plans will be updated if tumor coverage decreases by more than 5% or if radiation dose to normal tissues increases by more than 10%; otherwise, the original plan will continue. The study aims to determine how often plan adjustments are needed and to identify which disease sites are most likely to experience significant anatomical changes during treatment. Primary Objective: * Define the frequency of replanning necessary to ensure tumor coverage never falls below 95% (or 5% drop) of the prescribed daily dose in participants with intact (gross) tumors to keep the tumor control optimal throughout the multi-week treatment regimen. * Define the frequency of replanning necessary to ensure organs-at-risk (critical organs) do not deviate by more than 10% of the initially approved dose constraints to keep the normal tissue complication minimal throughout the multi-week treatment regimen. Secondary Objectives * Establish a cone beam CT (CBCT)-based framework for quantifying body surface changes throughout the treatment course. This goal will be achieved by developing a novel algorithm that detects and tracks external anatomical variations longitudinally, without requiring CBCT image enhancement, enabling precise assessment of daily participant setup consistency and anatomical stability. * Overcome daily CBCT quality limitations by generating synthetic CT images that accurately represent daily anatomy and support proton dose recalculation or verification planning. This goal will be achieved by developing a hybrid pipeline that integrates deep learning models with the deformable image registration algorithm, trained and validated on disease site-specific data. This will enable precise dose mapping and tissue density estimation, directly supporting adaptive planning decisions without the need of diagnostic- quality CT images.

Use of Transcranial Photobiomodulation to Improve Cognition and Self-Reported Outcomes in Survivors of Childhood Cancer

Survivors of childhood cancer are at greater risk for long-term cognitive impairments that include attention, executive function, intelligence, memory, and processing speed. The participants are a survivor of acute lymphoblastic leukemia (ALL) or Hodgkin's lymphoma (HL). Because of your treatment the participant may have developed trouble with thinking and learning. Primary Objective To evaluate the feasibility of using home-based tPBM paired with remote cognitive training to improve cognitive performance in survivors of ALL and HL. Secondary Objectives To estimate the potential efficacy of alpha and gamma frequency tPBM on cognitive performance in survivors of ALL and HL. Exploratory Objectives To estimate the effects of home-based tPBM paired with remote cognitive training on patient reported symptoms of executive dysfunction, sleep, depression, anxiety, fatigue, and pain in survivors of ALL and HL.