Search Results
Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary symptoms of Long COVID (REVERSE-LC) (REVERSE-LC)
The purpose of this study is to understand if a drug called baricitinib can help with thinking and memory problems after COVID-19 infection for people suffering with Long COVID. Some people have thinking and memory problems along with possible difficulty breathing, a racing heart, dizziness, and/or fatigue after COVID-19 called Long COVID. This includes things like having a hard time remembering people’s names, managing money, or keeping a job. For some patients, these issues may last several years. We still do not understand why these problems happen and why they last longer in some people. This study will look at the changes in brain function, heart function, and daily activities after taking baricitinib or placebo for people who experience Long COVID.
• documented COVID infection 6 or more months prior
• clinical evidence of Long COVID such as fatigue, chills, post-exertional malaise, trouble with memory/concentration ("brain fog"), headache, dysautonomia/postural orthostatic tachycardia syndrome, dizziness, unsteadiness, neuropathy, sleep disturbance, chest pain, palpitations, shortness of breath, cough, fainting spells, muscle aches, joint pain, nausea, diarrhea
• symptoms must have started after January 2020 and be present for at least 6 months prior starting the study
• symptoms must be reported to have an impact on quality of life and/or everyday functioning and to be at least somewhat bothersome
• see link to clinicaltrials.gov for complete inclusion criteria
• severe cognitive, physical, or psychological disability preventing participation
• currently pregnant or breastfeeding or planning to become pregnant or breastfeed during the course of the study
• admission to an ICU for treatment of acute COVID-19 infection
• cancer diagnosis in the past 5 years
• see link to clinicaltrials.gov for complete exclusion criteria
Assessment of customized bimodal stimulation for tinnitus
We are testing the usability of a medical device designed to treat tinnitus. The Lenire device is made by Neuromod Devices and is CE approved for use in Europe and FDA approved in the US. This neuromodulation device delivers sounds and tongue stimulation that work together to reduce tinnitus. We are interested in your feedback after using the Lenire device with the modified stimulation program. This research study lasts about 3 months.
• Subjective Tinnitus
• Tinnitus has a dominant pitch
• willing to commit to a12 week study
• objective tinnitus
• started using hearing aids within the past 3 months
• have an electro-active implanted device
A phase 1a/b study to evaluate the safety and efficacy of OPB-101, an autologous mesothelin (MSLN) CAR T cell therapy with antigen-dependent expression of OUTSMART designed IL-2 cytokine in platinum-resistant ovarian cancer
This study will enroll patients with ovarian cancer who have experienced their cancer worsening after at least two previous treatments. This study will give these patients OPB-101, a genetically engineered CAR-T cell therapy product - a product that will be created from the patient's own T-cells - that the researchers hope has been designed to more accurately recognize and destroy the cancer cells. The goal of this study is to make sure OPB-101 is safe to give, if it is effective against this type of cancer, and to find the best dose of OPB-101 to give patients.
• confirmed diagnosis of high grade serous epithelial ovarian, peritoneal, or fallopian tube cancer
• recurrent platinum-resistant disease, cancer has recurred within 6 months of the last dose of platinum-based chemotherapy
• received at least 2 but no more than 3 prior lines of systemic chemotherapy including a platinum based chemotherapy
• may not be able to do strenuous activity but able to walk and do work of a light or sedentary nature, e.g., light house work, office work
• women childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 12 months after the last dose of therapy
• see link to clinicaltrials.gov for complete inclusion criteria
• women who are pregnant or breastfeeding
• uncontrolled bacterial, fungal, or viral infections
• active invasive cancer other than the cancer under study
• significant lung disease
• active central nervous system (CNS) involvement
• dependent on intravenous hydration or total parenteral nutrition
• see link to clinicaltrials.gov for complete exclusion criteria
A placebo-controlled, randomized clinical trial to assess the safety, feasibility, and pharmacokinetics of Microbiota transplant therapy with antibiotic preconditioning and fiber supplementation in patients with pulmonary arterial hypertension
There is evidence that the gut microbes interact with the body’s immune system, and people with pulmonary hypertension may have altered composition of gut microbes. We are studying whether transplanting gut microbes from healthy donors using a treatment called microbiota transplant therapy may have beneficial effects on pulmonary arterial hypertension.
• ages 18-75
• diagnosis of pulmonary arterial hypertension (PAH)
• on stable treatment for PAH for one month prior to enrollment
• able to swallow capsules
• able to provide blood sample and fecal sample
• active inflammatory bowel disease or celiac disease
• women who are pregnant or breastfeeding
• presence of ileostomy or colostomy
• on immunosuppressants (calcineurin inhibitors, prednisone at a dose of 20 mg/day or more, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors).
• history of solid organ or bone marrow transplant
• anticipated recurrent antibiotic use (patients with frequent urinary tract infections or sinusitis)
• history of severe anaphylactic food allergy
• receiving cancer chemotherapy, immunotherapy, or radiation
Research Evaluating Vagal Excitation and Anatomical Links
We are studying the effects of stimulating the vagus nerve. The vagus nerve connects the brain to many organs in the body. Vagus nerve stimulation (VNS) is already approved by the United States Food and Drug Administration (FDA) to treat depression and epilepsy. We want to learn more about how it affects other parts of our bodies, such as the heart, metabolism, the immune system, and the nervous system. We hope that by understanding how VNS affects the body as a whole, we can develop new treatments for other conditions, or help to improve its use for depression and epilepsy.
• previously implanted with a vagal nerve stimulator (VNS) device to treat Major Depressive Disorder and on stable medications for at least 2 months
• OR will receive a VNS implant as standard clinical care, for Major Depressive Disorder and will receive VNS clinical standard of care programming after study completion. standard clinical care, for Major Depressive Disorder and will receive VNS clinical standard of care programming after completing the study
• OR previously been implanted with a VNS for Epilepsy that isn't controlled with medication
• OR will receive a VNS implant as standard clinical care, and will receive VNS clinical standard of care programming after study completion
• Contact study staff for additional requirements for each group
• willing to use effective birth control for the entire time period of the study
• has a prior implantable stimulation device, other than a VNS device
• uses or is expected during the study to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy
• unable to speak English
• additional medical or mental health issues (study staff will review)
A Phase 3 open-label, randomized, active-controlled, multicenter trial to evaluate the efficacy and safety of orally administered BAY 2927088 compared with standard of care as a first-line therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2-activating mutations.
This clinical research study is being conducted to gain knowledge about a new drug called BAY 2927088 for a type of cancer called advanced non-small cell lung cancer, which cannot be removed with surgery or has spread to other parts of the body, and has a mutation in the HER2 gene.
• locally advanced non small cell lung cancer (NSCLC) not suitable for definitive therapy or recurrent or metastatic NSCLC at screening
• treatment with at least one prior systemic therapy for advanced disease
• people who do not have standard of care access due to any reason, are intolerant to, or are not eligible for
• documented activating EGFR and/or HER2 mutation
• may be unable to do physically strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete Inclusion criteria
• history of primary brain or leptomeningeal disease (symptomatic or asymptomatic), presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local treatment (such as radiotherapy or surgery)
• history of congestive heart failure (CHF) Class >II according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment (e.g. ventricular arrhythmias, atrial fibrillation)
• see link to clinicaltrials.gov for complete Exclusion criteria
A Randomized Phase II Study of Letrozole Versus Observation in Patients with Newly Diagnosed Uterine Leiomyosarcoma
The purpose of this study is to find out if the drug letrozole is better or worse than not receiving treatment (called observation) following surgery for your type of cancer. Letrozole could prevent your cancer from returning but the cancer could grow while on treatment. There is currently no definitive data to support the use of Letrozole treatment for early stage Leiomyosarcoma. Letrozole has already been FDA-approved to treat other cancers, but it is investigational in this research.
• confirmed newly diagnosed uterine leiomyosarcoma with disease limited to the uterus
• tumor expresses ER positivity by immunohistochemistry
• completed hysterectomy and bilateral salpingo-oopherectomy no more than 12 weeks prior
• walking and able to do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• able to swallow oral medication
• see link to clinicaltrials.gov for complete inclusion criteria
• any other severe disease
• also has another cancer or has been treated for cancer in the past three years
• women who are pregnant or breastfeeding
• currently receiving chemotherapy or radiation therapy
• see link to clinicaltrials.gov for complete exclusion criteria
Proteomics of Post-Operative Complications in Patients undergoing CABG
This study aims to identify independent blood-based risk factors for postoperative complications and near-term events among patients undergoing CABG surgery. In particular, this study will be using proteomics, the study of all proteins produced by the cells found in blood, as well as genetic analysis to identify potential predictive markers of postoperative complications. We will collect blood samples from before and after surgery. This study does not involve any medical treatment other than the one prescribed by your doctor, nor does it involve any additional medical procedures.
• Undergoing CABG procedure at MHealth Fairview hospital
• 45-80 years of age
• high risk patient as determined by the Society of Thoracic Surgeons (STS) Risk Assessment Score after designated number of patients have been included (study staff will review)
A Multicenter Observational Study to Characterize Growth in Children with Idiopathic Short Stature
This research is being done to learn more about how children with idiopathic short stature grow. About 600 children with idiopathic short stature will be in this study across the world. The study will last a minimum of 6 months (i.e., three study visits). After a child has been in this study for at least 6 months, participants may be offered the option to exit this study and enroll in a different study with growth promoting agents.
• participants must be at least 2 years old
• no more than 14 years old if female, or less than16 years old if male
• height Z-score is at least -2.5 SDs compared to age and sex matched norms
• able to walk ambulatory stand without assistance (not applicable for children who are less than 5 years of age and less than 104 cm i.e. 41 inches in length)
• systemic disease or condition that may cause short stature, eg renal, neoplastic, pulmonary, cardiac, gastrointestinal, immunologic or metabolic disease
• presence of one or more pituitary hormone deficiencies (ACTH [adrenocorticotropic hormone], ADH [antidiuretic hormone], FSH [follicle-stimulating hormone], GH [growth hormone], LH [luteinising hormone], TSH [thyroid-stimulating hormone]).
• diagnosis of hypothyroidism, adrenal insufficiency or hypogonadism (treated or untreated).
• Growth Hormone (GH) level below 10 ng/mL following a stimulation test. This does not apply to potential participants who are currently being treated with hGH for ISS
• known chromosomal imbalance or genetic variant causing short stature syndrome, including but not limited to Laron syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turners syndrome, disproportionate skeletal dysplasias, abnormal short stature homeobox (SHOX) gene analysis, Rasopathy (including Noonan’s Syndrome), or absence of GH receptors
• bone age advanced over chronological age by more than 3 years
• active cancer, chemotherapy or radiation therapy
A Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician s Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma (FIRST-308) (FIRST-308)
The main purpose of this study is to learn how well tinengotinib works and how safe tinengotinib is compared with the study doctor’s choice of chemotherapy treatment. The purpose of Part A of the study will be to determine the best dose of tinengotinib to use in Part B of the study. The purpose of Part B is to learn more about how well tinengotinib works and how safe it is compared with the study doctor’s choice of treatment.
• adenocarcinoma of biliary origin (bile ducts) that can't be surgically removed or is metastatic (spread to other areas of the body)
• cancer has FGFR2 fusion/rearrangement gene status
• received at least one line of prior chemotherapy and one FDA approved FGFR inhibitor
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• received two or more FGFR inhibitors, either approved or investigational drugs
• brain or central nervous system (CNS) metastases
• presence of another cancer that requires treatment
• uncontrolled hypertension (blood pressure of ≥ 150 mm Hg systolic and/or ≥ 90 mm Hg diastolic despite treatment with antihypertensive medications)
Circuit-Based Deep Brain Stimulation for Parkinson's disease; Udall Clinical Core
The goal of this study is to provide comprehensive longitudinal assessments of a cohort of PD patients before, during, and after DBS surgery, including neurological, neurophysiological, and neuropsychological data.
• age 21 years and older
• diagnosis of Parkinson's disease
• candidate for DBS
• diagnosis of dementia
• women who are pregnant
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy (ASCENT-GYN-01)
The purpose of this research study is to learn if sacituzumab govitecan (also called SG or Trodelvy®) can improve lifespan and delay the growth or spread of the disease in participants with endometrial cancer when compared to chemotherapy (doxorubicin or paclitaxel).
• diagnosis of endometrial cancer that has not responded to treatment or has recurred
• up to 3 prior lines of systemic therapy including platinum-based chemotherapy and anti-PD-1/PD-L1 therapy, either in combination or separately
• assigned female at birth
• if of child bearing age, must use birth control as specified by the study
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• eligible for rechallenge with platinum-based chemotherapy
• continue to have significant side effects from treatment
• active second cancer or a history of another active cancer in the past 3 years
• a history of significant cardiovascular disease including myocardial infarction, significant arrhythmia, congestive heart failure
• history of HIV-1 or 2
• active hepatitis B virus (HBV) or hepatitis C virus (HCV)
• women who are pregnant or breast feeding
A Phase 1a/b Study of ADRX-0405 in Subjects with Select Advanced Solid Tumors
This study aims to evaluate the safety and tolerability of ADRX-0405 in people with advanced cancer and determine the optimal dose for treatment.
• age 18 or older
• Phase 1a: confirmed advanced solid tumors (metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC))
• Phase 1b: confirmed prostate adenocarcinoma that is confirmed to be castration resistant and that is intolerant/resistant to standard of care (SOC) therapies
• see link to clinicaltrials.gov for complete inclusion criteria
• active and uncontrolled central nervous system metastases
• have received an anticancer or investigational therapy prior to the first dose of study drug
• history of ILD/pneumonitis requiring steroid treatment within the past 2 years, current ILD/pneumonitis, or an active infection requiring systemic antibiotics (prophylactic antibiotics permitted)
• see link to clinicaltrials.gov for complete exclusion criteria
A pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) who are receiving an angiotensin II receptor blocker (ARB) (ACTION3)
A clinical research study for primary focal segmental glomerulosclerosis (FSGS), or genetic focal segmental glomerulosclerosis (FSGS), or focal segmental glomerulosclerosis (FSGS) of undetermined cause in pediatric (12-17 years) and adult patients. Eligible participants will be assigned to receive either DMX-200 (repagermanium) or placebo (50/50 chance) over a treatment period, with total participation up to 28 month, with potential for participation in an Open Label Extension study period. The main purpose of this study is to see if DMX-200 reduces proteinuria and slows the loss of kidney function in those with FSGS.
• 12-80 years old;
• Primary FSGS, genetic FSGS or FSGS of undetermined cause
• Receiving an ARB, or willing to take one for the study
• see link to clinicaltrials.gov for complete inclusion criteria
• Secondary FSGS
• Not previously treated with standard of care therapies (including steroids)
• Unable to swallow oral medication
• see clinical to clinicaltrials.gov for complete exclusion criteria
A Phase 1/2a Open-Label Dose-Ranging and Observer-Blind Placebo-Controlled, Safety and Immunogenicity Study of mRNA-1647 Cytomegalovirus Vaccine in Female and Male Participants 9 to 15 Years of Age; mRNA-1647-P104
This study it to test an investigational vaccine called mRNA-1647 that is being developed for preventing cytomegalovirus (CMV) infection in people. CMV is a common virus that can spread easily through an infected person’s saliva or other body fluids such as blood, urine, and breast milk. We want see if the trial vaccine can prevent CMV infection in participants who have not been previously infected, to understand the safety (how many side effects you may have) of the trial vaccine, and to see if the trial vaccine results in participants making antibodies to CMV.
• female or male 9 to 15 years of age
• in good general health
• BMI requirements ( study staff will review)
• female participants of childbearing potential: negative pregnancy test and adequate contraception for at least 28 days prior to receiving vaccine through 3 months following vaccine administration
• received, or plans to receive, any nonstudy vaccine less than 28 days prior to or after any study medication
• any diagnosis or condition requiring significant changes in management or medication within the 2 months before starting the study
• contact study staff for review of additional exclusion criteria
A Multicenter, Randomized, Parallel-group, Double-blind, Two-arm, Phase III Study to Evaluate the Safety and Efficacy of Anifrolumab Compared with Placebo in Male and Female Participants 18 to 70 Years of Age Inclusive with Systemic Sclerosis (DAISY)
We are doing this study to learn more about anifrolumab (SAPHNELOTM) in patients with systemic sclerosis and to better understand the studied disease and associated health problems. Systemic sclerosis (scleroderma) affects the skin as well as other organs, such as blood vessels, muscles and joints, digestive tract, kidneys, lungs and heart.
• 18 to 70 years old
• diagnosis of systemic sclerosis within 6 years from first non-Raynaud's symptoms
• skin at injections sites is without symptoms
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• severe heart or lung disease
• history of any other inflammatory diseases
• history of hematopoietic stem cell transplantation or solid organ or limb transplantation
• current or a history of cancer within past 5 years
• active current or history of reoccurring infections
Effects of tobacco and nicotine cessation on biomarkers
This study will bank biological samples (cells from mouth, urine, blood, saliva) to investigate the effects of quitting smoking or vaping on different markers in the body.
• 21 years of age or older
• in good health
• smokes cigarettes daily
• willing to abstain from smoking for 15 days
• marijuana use
COG AALL1821 - A Phase 2 Study of Blinatumomab (NSC# 765986, IND# 147294) in Combination with Nivolumab (NSC # 748726, IND# 147294), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/=1 to < 31 Years Old with First Relapse
The overall goal of this study is to determine if treating first relapse B-cell acute lymphoblastic leukemia (B-ALL) with a combination of blinatumomab and nivolumab is more effective than blinatumomab alone.
• 1 to 30 years old
• must have first relapse of CD19+ B-ALL (relapse blasts must express CD19)
• must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
• see link to clinicaltrials.gov for completed Inclusion criteria
• other types of blood disorders including: B-lymphoblastic lymphoma (B-LLy), Burkitt leukemia/lymphoma or mature B-cell leukemia, Philadelphia chromosome positive (Ph+) B-ALL, mixed phenotype acute leukemia (MPAL), known Charcot-Marie-Tooth disease, MYC translocation associated with mature (Burkitt) B-cell ALL
• active, uncontrolled infection
• significant central nervous system pathology including history of severe neurologic disorder or autoimmune disease with CNS involvement
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
An Expanded Access Program for the non-invasive detection of clear cell renal cell carcinoma (ccRCC) in patients with renal masses utilizing 89Zirconium-labelled girentuximab (89Zr-DFO-girentuximab)
This Expanded Access Program (EAP) will enable the use of 89Zr-DFO-girentuximab with PET/CT scans to detect clear cell renal cell carcinoma in patients with kidney masses. It aims to gather real-world safety and effectiveness data and understand how PET imaging affects patient management.
• 18 to 99 years old
• evidence of renal mass(es) obtained from conventional diagnostic imaging with CT or MRI
• agree to practice highly effective contraception until a minimum of 42 days after receiving study drug
• mass known to be a metastasis of another primary tumor
• active non-renal cancer requiring therapy
• women who are pregnant or breastfeeding
A Multicenter Observational Study of GammaTile Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms
We are studying the effectiveness of GammaTiles TM that are placed during surgery done to remove brain tumors. GammaTiles TM are used to deliver radiation to the surgical area in the brain. We are collecting information about the effectiveness and side effects and will compare to people who receive the usual treatment.
• undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles.
• unable to have pre-operative and post-operative imaging for disease and implant assessment
• major medical or psychiatric illness (study staff will review)
• unable to speak and read English
CATALINA-2: A Phase 2 Study Evaluating the Efficacy and Safety of TORL-1-23 in Women with Advanced Platinum-Resistant Epithelial Ovarian Cancer (Including Primary Peritoneal and Fallopian Tube Cancers) Expressing Claudin 6
This study is being conducted to determine the safest and most effective dose of TORL-1-23 in treating advanced platinum-resistant ovarian cancer.
• diagnosis of advanced (unresectable) or metastatic (has spread) high grade serous ovarian, primary peritoneal (i.e, of primary origin), or fallopian tube cancer
• positive for CLDN6 expression
• have platinum-resistant disease
• may not be able to do strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• must agree to use a highly effective birth control method from the time of the first study drug treatment through 7 months after the last study drug treatment
• must agree to not breastfeed from the first dose of study treatment through 90 days after the last dose of study treatment
• see link to clinicaltrials.gov for complete inclusion criteria
• have not recovered from serious side effects of previous treatment
• progressive or symptomatic brain metastases
• history of significant heart disease
• history of another cancer within 3 years (exception of basal or squamous cell carcinoma of the skin)
• see link to clinicaltrials.gov for complete exclusion criteria
A Phase 1B/2 pan-tumor, open-label study to evaluate the efficacy and safety of ifinatamab deruxtecan (I-DXD) in subjects with recurrent or metastatic solid tumors (IDeate-Pantumor02)
The purpose of this study is to learn more about an investigational drug called ifinatamab deruxtecan (I-DXd; DS-7300. It is being studied to see if it is safe, and if cancer improves while taking it. I-DXd is a type of drug called an antibody drug conjugate (ADC). ADCs are made to attach to tumor cells to deliver chemotherapy directly to tumor cells while sparing healthy cells.
• disease progression on or after the previous standard-of-care regimen for advanced/metastatic cancer
• unable to do strenuous activity but able to walk and do work of a sedentary nature, e.g., light house work, office work
• additional criteria required based on the type of cancer (pancreatic, breast, bladder, etc.)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• prior treatment with orlotamab, enoblituzumab, or other B7-homologue 3 (B7-H3)-targeted agents, including I-DXd
• clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
MT2024-16: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects with Hidradenitis Suppurativa (Regulate-HS)
This research study is for people who have Hidradenitis Suppurativa (HS) and it is moderate or severe in intensity and have been treated with at least one conventional therapy for HS. This study involves the investigational drug SBT777101, which is created by genetically modifying a patient’s own immune cells. The word “investigational” means that this drug has not been approved by the U.S. Food and Drug Administration (FDA) for marketing. SBT777101 is being developed to treat people with hidradenitis suppurativa (HS).
PEPN2111 - A Phase 1/2 Trial of CBL0137 (NSC# 825802, IND# 155843) in Patients with Relapsed or Refractory Solid Tumors including CNS Tumors and Lymphoma
A Phase I/II trial of single agent intravenous CBL0137 in pediatric patients (≥ 12 months and ≤ 30 years) with relapsed/refractory solid tumors, including CNS tumors and lymphoma.
• 12 months to 30 years old
• patients with relapsed or refractory solid tumors or lymphoma, including patients with CNS tumors or known CNS metastases, or patients with progressive or recurrent DIPG (diagnosed by biopsy or imaging characteristics) and other H3 K27M-mutant diffuse midline gliomas previously treated with radiation therapy, or patients with relapsed or refractory osteosarcoma
• patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment
• patients have consented to receive a central venous catheter prior to the administration of CBL0137
• see link to clnicaltrials.gov for complete inclusion and exclusion criteria
• pregnant or breast-feeding women
• patients who have an uncontrolled infection
• patients who have received a prior solid organ transplantation
Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF (STRONG-CF)
There are currently two main ways of measuring nutrition in the Cystic Fibrosis (CF) population: body mass index (BMI) and laboratory values. This study plans to look at more ways to measure nutrition, and body composition, like the percentages of fat, bone and muscle in your body. One of the ways we will measure these items is by using dual energy X-ray absorptiometry (DXA) scan, which is a type of x-ray. This study hopes to provide researchers with more detailed information about nutrition and body composition in adults with CF.
• diagnosed with Cystic Fibrosis
• clinically stable with no significant changes in health status within the 14 days prior to the first study visit
• no prior solid organ transplantation
• no initiation of an investigation drug within 28 days before
• no initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston, CFTR modulator) within 28 days
• no acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within 14 days
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Optune® (TTFields, 200 kHz) Concomitant with Maintenance Temozolomide and Pembrolizumab Versus Optune® Concomitant with Maintenance Temozolomide and Placebo for the Treatment of Newly Diagnosed Glioblastoma (EF-41/KEYNOTE D58) (EF-41)
The current study aims at testing the efficacy of concomitant temozolomide, Optune and pembrolizumab compared to concomitant temozolomide, Optune and placebo, following preclinical and clinical evidence demonstrating the potential augmentation of the immune response against glioblastoma under this regimen.
• new diagnosis of Glioblastoma (GBM)
• recovered from surgery (if done)
• completed standard adjuvant chemoradiotherapy or radiotherapy (RT) with TMZ chemotherapy
• may be to do physically strenuous activity but able to walk able to carry out work of a light or sedentary nature, e.g., light house work, office work
• on stable or decreasing dose of corticosteroids
• received prior therapy with an anti-Programmed Cell Death 1 (PD-1), anti- Programmed Cell Death-Ligand 1(PD-L1), or anti Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.Cytotoxic T-Lymphocyte-Associated protein 4 (CTLA-4), OX 40, CD137)
• diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
• known additional malignancy that is progressing or has required active treatment within the past 3 years
MT2021-11: An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects with Epstein-Barr Virus-associated Diseases
This research is being done to determine whether the investigational drug tabelecleucel (allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes [EBV-CTLs]) can help people with EBV-associated diseases.
• diagnosis of Epstein-Barr Virus (EBV) disorder
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.com for additional inclusion criteria
• women who are breastfeeding or pregnant
• currently active Burkitt, T-cell, natural killer/T-cell lymphoma/LPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy
• serious known active infections
• additional exclusion criteria apply (study staff will review)
COG ACNS1931 - A Phase 3 Study of Selumetinib (NSC# 748727, IND# 77782) or Selumetinib in Combination with Vinblastine for non-NF1, non-TSC Patients with Recurrent or Progressive Low-Grade Gliomas (LGGs) Lacking BRAFV600E or IDH1 Mutations
This phase III trial investigates the best dose of vinblastine in combination with selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib alone in treating children and young adults with low-grade glioma (a common type of brain cancer) that has come back after prior treatment (recurrent) or does not respond to therapy (progressive). Selumetinib is a drug that works by blocking a protein that lets tumor cells grow without stopping. Vinblastine blocks cell growth by stopping cell division and may kill cancer cells. Giving selumetinib in combination with vinblastine may work better than selumetinib alone in treating recurrent or progressive low-grade glioma.
• ages 2 to 21 at time of starting the study
• diagnosis of low-grade glioma or low-grade astrocytoma brain tumor
• tumor size increased or returned after treatment with at least one cancer therapy
• high blood pressure (hypertension) must be under control
• must be able to swallow whole capsules
• contact study staff for additional criteria
• treatment for another tumor in the past year
• any serious medical or mental health diagnosis, including substance use disorders or ophthalmological conditions (study staff will review)
• women who are pregnant or breast feeding
HM2023-21: A Phase 3 Randomized Study Comparing Talquetamab in Combination with Pomalidomide (Tal-P), Talquetamab in Combination with Teclistamab (Tal-Tec), and Investigator s Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants with Relapsed or Refractory Myeloma who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide (MonumenTAL-6)
The purpose of this study is to compare the effects of talquetamab in combination with teclistamab (Tal-Tec), the effects of talquetamab in combination with pomalidomide (Tal-P), and the effects of either the combination of elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd) in treating patients with multiple myeloma, who have not responded to previous treatment.
• diagnosis of multiple myeloma
• cancer that has recurred or has not improved with treatment
• previously treated 1 to 4 times (lines of therapy)
• able to walk and complete all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• stroke, transient ischemic attack, or seizure in the past 6 months
• active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma
HM2024-11: A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY COMPARING THE EFFICACY AND SAFETY OF GLOFITAMAB (RO7082859) IN COMBINATION WITH POLATUZUMAB VEDOTIN PLUS RITUXIMAB, CYCLOPHOSPHAMIDE, DOXORUBICIN, AND PREDNISONE (POLA-R-CHP) VERSUS POLATUZUMAB IN PREVIOUSLY UNTREATED PATIENTS WITH LARGE B-CELL LYMPHOMA
The purpose of this study is to compare the efficacy and safety of glofitamab, a novel cluster of differentiation (CD) 20/CD3 bispecific antibody, in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola‑R‑CHP) versus Pola‑R‑CHP in patients with previously untreated CD20-positive large B-cell lymphoma (LBCL).
• 18 to 80 years old
• have not received any treatment for Large B-Cell Lymphoma
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• prior solid organ transplantation
• history of significant cardiovascular disease
• current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
• clinically significant liver disease
• chronic hepatitis B infection, hepatitis C, or HIV