
Search Results
A Randomized, Double-blind, Placebo-controlled Phase 4 Clinical Trial to Evaluate the Long-term Safety and Efficacy of Avacopan in Subjects With Antineutrophil Cytoplasmic Antibody (ANCA)-associated Vasculitis
To evaluate the long-term safety of avacopan in participants with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV)
• newly diagnosed or relapse of granulomatosis and induction treatment with cyclophosphamide or rituximab is needed
• see link to clinicaltrials.gov for complete Inclusion criteria
• any other known multisystem autoimmune disease
• had a kidney transplant
• cancer in the past 5 years
• any significant cardiovascular disease
• taking an oral daily dose of a glucocorticoid of more than 10 mg prednisone equivalent for more than 6 weeks
• see link to clinicaltrials.gov for complete Exclusion criteria
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
MT2024-08: Phase I open-label, dose escalation trial of BI 1831169 monotherapy and in combination with an anti-PD-1 mAb in patients with advanced or metastatic solid tumors.
This study tests the use of the oncolytic virus BI1831169 (VSV-GP) as an immunotherapy in patients with advanced solid tumors. This trial is the first-in-human trial to test the safety and early efficacy of BI1831169 by itself (Part 1) and in combination with the PD-1 inhibitor ezabenlimab (Part 2).
• confirmed diagnosis of an advanced, and/or metastatic or relapsed/refractory solid tumor that can not be surgically removed
• must have exhausted available treatment options or refused established treatment options
• restricted from physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for additional Inclusion criteria
• major surgery or radiation therapy in the past 4 weeks
• active hepatitis B or C infection
• severe or serious, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation (study staff will review)
• see link to clinicaltrials.gov for complete Exclusion criteria
MT2023-28: A Phase 1 Basket Study Evaluating the Safety and Feasibility of T-Plex, Autologous Customized T Cell Receptor-Engineered T Cells Targeting Multiple Peptide/HLA Antigens in Participants with Antigen-positive Locally Advanced (Unresectable) or Metastatic Solid Tumors: PLEXI-T(TM)
This study aims to find out if investigational new drugs, TSC-204-A0201, TSC-204- A0702 and TSC-200-A0201, can help your cancer better than the standard of care (SOC) that are currently available and accepted by medical experts as a proper treatment. T-cells are part of the immune system and develop from stem cells in the bone marrow. They help protect the body from infection and fight cancer. For this study, T-cells will be collected through a process called leukapheresis. T-cells from your leukapheresis will be used to make the study drugs specifically tailored for you and your immune system. The purpose of the study is to learn if the study drugs are safe and effective in treating your type of cancer.
• previously received at least one line of standard systemic therapy for advanced or metastatic cancer and have either progressed, recurred, or were intolerant to the previous treatment
• unable to do physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• women must not be pregnant or breastfeeding
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• known active CNS metastases
• systemic steroid therapy
• history of a bleeding disorder
• active, uncontrolled bacterial, fungal, or viral infection
• prior history or have another cancer
Geniculate Artery Embolization
Osteoarthritis (OA) is a leading cause of disability and chronic pain that reduces physical activity and daily activities. In this clinical research study, the goal is to learn more about geniculate artery (located in the knee) embolization (GAE) treatment to see if it will reduce pain as well as stiffness and difficulty performing daily activities caused by knee OA and if it can be performed safely.
• osteoarthritis of the one knee with symptoms that have not improved after at least 3 months of treatment such as PT, injection, medications,
• partial knee replacement and total knee arthroplasty are not currently options (may be in the future)
• 40-70 years of age
• weight greater than 250 pounds
• smoke or have smoked tobacco regularly (smoking 1 or more tobacco product(s) per week) within the last year
• diabetic with A1C greater than 9%
• advanced peripheral arterial disease
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 PHASE III TRIAL OF ONE VS. TWO YEARS OF MAINTENANCE OLAPARIB, WITH OR WITHOUT BEVACIZUMAB, IN PATIENTS WITH BRCA1/2 MUTATED OR HOMOLOGOUS RECOMBINATION DEFICIENT (HRD+) OVARIAN CANCER FOLLOWING RESPONSE TO FIRST LINE PLATINUM-BASED CHEMOTHERAPY
The usual approach for patients who are not in a study is treatment of ovarian cancer with surgery, radiation, or U.S. Food and Drug Administration (FDA)-approved drugs. Sometimes, combinations of these treatments are used. We are doing this study because we want to find out if the use of Olaparib for one year is as good or worse than the usual approach for ovarian tumor.
• newly diagnosed, confirmed stage III or IV ovarian cancer of the following types: high grade serous or endometrioid, or other epithelial ovarian cancer with BRCA1/2 alteration
• ovarian cancer includes ovarian, fallopian, or primary peritoneal cancer
• must have had cytoreductive surgery
• must have completed first line platinum-based therapy before starting the study (no more than 12 weeks prior)
• not pregnant or breastfeeding
• see link to clinicaltrials.gov for complete inclusion criteria
Single-Arm Phase II Study of Carboplatin and Mirvetuximab Soravtansine in First-Line Treatment of Patients receiving Neoadjuvant Chemotherapy with Advanced-Stage Ovarian, Fallopian Tube or Primary Peritoneal Cancer who are Folate Receptor positive
The purpose of the study is to document the feasibility of undergoing surgery for cancer after receiving 3 cycles of neoadjuvant chemotherapy carboplatin and mirvetuximab soravtansine as first-line treatment in patients with advanced-stage ovarian cancer that are Folate Receptor alpha positive.
• confirmed high grade serous epithelial ovarian cancer
• stage III or IV disease and be appropriate to receive neoadjuvant chemotherapy (before surgery)
• strenuous activity may be restricted but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• women of childbearing potential (WCBP) must agree to use highly effective contraceptive method(s) while on MIRV and for at least 4 months after the last dose
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• previously treated with a systemic anti-cancer therapy
• low-grade serous, endometrioid, clear cell, or mucinous cancer
• women who have active or chronic corneal (eye) disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision
• history of hepatitis B or C infection or human immunodeficiency virus (HIV) infection
• women who are pregnant or breastfeeding
• history of other cancer within 3 years prior
• significant heart, lung, liver disease
An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of Intestinal Microbiota Transplantation In Patients Undergoing Colon Resection
We have determined that the microbes (bacteria) in the colon can play a role in causing and preventing complications of colon surgery. While the surgical bowel prep before surgery eliminates the harmful bacteria, it also eliminates the beneficial bacteria that aid wound healing. The purpose of this study is to determine if we can restore the presence of good bacteria (also known as ‘intestinal microbiota’) in the colon by transplanting them from a healthy donor.
• 18 to 75 years old
• having surgery for diverticulitis or sigmoid colon cancer
• able to provide fecal samples
• see link to clinicaltrials.gov for complete inclusion criteria
• history of inflammatory bowel disease (Crohn's, Ulcerative Colitis)
• women who are pregnant or breastfeeding
• presence of ileostomy or colostomy
• history of solid organ or bone marrow transplant -receiving cancer chemotherapy, immunotherapy, or radiation
• see link to clinicaltrials.gov for complete exclusion criteria
A Phase 1b, Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Subjects With High-risk Biochemical Recurrence of Nonmetastatic Castration-sensitive Prostate Cancer After Definitive Therapy
This study is trying a new treatment (Xaluritamig) for men whose prostate cancer returned after the first treatment, but has not spread. The objective is to determine if Xaluritamig is safe and works well without causing negative side effects seen in other treatments. Participants will get Xaluritamig through a vein in their arm over six times with doctors observing for side effects and to see how the cancer reacts.
• confirmed adenocarcinoma of the prostate
• treated by radical prostatectomy (RP) or radiotherapy (XRT) (including brachytherapy) or both with intention of cure
• PSA has doubled in 12 months or less
• normal testosterone level (greater than 150ng/dL)
• must be able to walk, carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for prostate cancer
• prior systemic biologic therapy, including immunotherapy, for prostate cancer
• men with a female partner of childbearing potential or who are pregnant, who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 6 months after the last dose of xaluritamig
A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants with Advanced Cancer (TRIO049)
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer.
• advanced solid tumor
• restricted strenuous physical activity but can walk and able to carry light work e.g., light house work, office work
• progressive or symptomatic brain metastases
• serious, uncontrolled medical disorder or active, uncontrolled infection
• history of significant hear disease
• history of another cancer within 3 years
• women who are pregnant or breast feeding
• contact study staff for additional exclusion criteria
10,000 Families Study
The purpose of this study is to study the evolution of early life risk factors that may lead to cancer and other conditions. This is a prospective cohort study of families who reside in Minnesota.
• 1st Participant: 18+ living in MN
• Other family members: All ages and must live in MN, ND, SD, IA, or WI
• Participants ages 0-17 must have a parent consent to their participation and assist with study activities
• Unwilling or unable to provide DNA and blood sample
• Does not have at least 1 living family member in MN IA, ND, SD, or WI
Evaluation of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKi) resistance in the tumor tissue of Non-small cell lung cancer (NSCLC) patients
This study is about discovering how Non-small cell lung cancer becomes resistant to EGFR TKI targeted therapy in order to predict and prevent this cancer from not responding to treatment.
• Age 18-85 years
• confirmed advanced adenocarcinoma of the lung
• identified EGFR mutation
• treatment with osimertinib
• radiation or other drug treatments other than osimertinib
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Baricitinib in Children from 6 Years& Less than 18 Years of Age with Alopecia Areata
We are conducting a research study for children ages 6-17 with patchy Alopecia Areata (AA). The purpose of this research study is to learn more about the safety, tolerability and efficacy of an investigational drug called Baricitinib. This study will compare the investigational drug to a placebo (inactive substance) to see how well the investigational drug works.
• children 6 to 18 years old
• at or above the 5th percentile of weight for age
• diagnosis of Alopecia Areata (AA) for at least 1 year
• current AA episode of at least 6 months duration with hair loss encompassing 50% or more of the scalp
• history of trial and failure with at least 1 available treatment
• history of psychological counseling related to AA
• primarily diffuse type of AA (characterized by diffuse hair shedding)
• currently experiencing other forms of alopecia including, but not limited to: trichotillomania, TE, chemotherapy-induced hair loss, or any other concomitant conditions (for example, tinea capitis, psoriasis, lupus erythematosus, or secondary syphilis)
D2D Oral Microbiome and Human Papillomavirus
Throat cancer linked to HPV is on the rise. While most people clear the HPV virus naturally, it can sometimes stay and cause throat cancer. Our research studies how mouth bacteria may help or hurt this process. We hope to develop simple, low-cost tests for early detection at the dentist. Participation involves a survey, spitting into a tube and getting a quick swab of your tonsils to collect microbes. This study is available at the D2D Building at the Minnesota State Fair.
• 18-70 years old
• still have tonsils
• speak and read English
• history of tonsillectomy
MT2020-08 A Phase 1/1b Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR0191(azercabtagene zapreleucel or azer-cel), in Subjects with Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)
The purpose of this research study is to obtain information on the safety and effectiveness of PBCAR0191 to treat certain types of cancers, such as Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia. It is made from a type of blood cells known as T cells. The T cells in PBCAR0191 came from people who have donated their blood. The donated T cells have been genetically changed, so that they may be able to kill specific cancer cells commonly present in Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia.
• diagnosis of Non-Hodgkin Lymphoma
• received at least 2, but no more than 7 prior chemotherapy-containing treatment regimens
• previously treated with CD19-directed autologous CAR T therapies have received no more than 2 lines of therapy after administration of their previous CAR T product
• restricted in strenuous activity but able to walk and able to carry out light work e.g., light house work, office work
• adequate bone marrow, renal, hepatic, pulmonary, and cardiac function (study staff will review)
• prior or active CNS disease
• uncontrolled and serious fungal, bacterial, viral, protozoal, or other infection
• active hepatitis B or hepatitis C
• any known uncontrolled cardiovascular disease
• contact study staff for additional exclusion criteria
A Phase 3, open-label, randomized 2-arm study comparing the clinical efficacy and safety of niraparib with temozolomide in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma
This study compares treatment with niraparib to temozolomide in adult participants who have newly-diagnosed, MGMT unmethylated glioblastoma.
• newly-diagnosed intracranial Glioblastoma (GBM)
• unmethylated MGMT promoter
• no prior treatment for GBM (including brachytherapy or BCNU wafers), other than surgical resection or biopsy
• not pregnant, planning to get pregnant, or breastfeeding
• for participants of child bearing age, highly effective birth control is required
• normal blood pressure (BP) or adequately treated and controlled hypertension (defined as systolic BP ≤140 mmHg and diastolic BP ≤90 mmHg)
• able to swallow oral medications whole
• see link to clinicaltrials.gov for complete Inclusion criteria
• metastatic or predominant leptomeningeal disease
• Current active pneumonitis or any history of pneumonitis requiring steroids (any dose) or immunomodulatory treatment within 90 days of planned start of the study
• gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels
• cirrhosis or current unstable liver or biliary disease
• see link to clinicaltrials.gov for complete Exclusion criteria
Evaluation of Microbiota Transplant Therapy in Patients with Alopecia Areata
The purpose of this study is to determine if microbiota transplant therapy (MTT) is an effective treatment for patients with alopecia areata, alopecia totalis, and alopecia universalis. We will be testing two different ways of doing the Microbiota transplant therapy (MTT): half the people who choose to be part of this study will take antibiotics before the transplant and half will take placebo antibiotics. We will collect 5 types of samples (2 or more times during the study): blood samples, skin samples, skin swabs, hair, and fecal samples.
• 18 to 75 years of age
• moderate to severe alopecia areata with at least 30% scalp hair loss
• hair loss lasting for at least 3 months
• must be willing to stop using other types of medications to treat Alopecia Areata throughout the study
• evidence of active, ongoing regrowth of hair
• see link to clinicaltrials.gov for complete Inclusion criteria
• active medical conditions or cancer
• current gastrointestinal infection or use of antibiotics
• current treatment for gastrointestinal diagnosis or previous GI surgery (past 3 months)
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination with Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination with Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (COPERNICUS)
This study is being conducted to compare the efficacy of subcutaneous amivantamab plus lazertinib in previously untreated EGFR mutated non-small cell lung cancer OR subcutaneous amivantamab plus chemotherapy after having received prior therapy for EGFR mutated non-small cell lung cancer.
• new diagnosis of non-small cell lung cancer (NSCLC) OR metastatic (in other areas of the body) or is too advanced for treatment that will cure the cancer
• tumor has an epidermal growth factor receptor gene (EGFR) mutation
• able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work, but can't do strenuous physical activity
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
• not have fully recovered from surgery, or has surgery planned during the time the participant is expected to be in the study
• uncontrolled tumor-related pain
A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER TRIAL OF SELINEXOR IN MAINTENANCE THERAPY AFTER SYSTEMIC THERAPY FOR PATIENTS WITH P53WILD-TYPE, ADVANCED OR RECURRENT ENDOMETRIAL CARCINOMA
The purpose of this research study is to further evaluate the safety and effectiveness of selinexor for maintenance in patients with TP53 wild-type endometrial cancer.
• confirmed Endometrial cancer including: endometrioid, serous, undifferentiated, and carcinosarcoma
• Stage IV disease at diagnosis or first relapse
• may be unable to do physically strenuous activity but walk and 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
• gastrointestinal disease that could interfere with the absorption of selinexor (e.g., bowel obstruction, inability to swallow tablets, malabsorption syndrome, unresolved nausea, vomiting, diarrhea)
• serious psychiatric or medical condition that could interfere with participation
• another cancer in the past 3 years
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
ANHL2121: Phase 2 Study of Tovorafenib (DAY101) in Relapsed and Refractory Langerhans Cell Histiocytosis
This phase II trial tests the safety, side effects, best dose and activity of tovorafenib (DAY101) in treating patients with Langerhans cell histiocytosis that is growing, spreading, or getting worse (progressive), has come back (relapsed) after previous treatment, or does not respond to therapy (refractory). Langerhans cell histiocytosis is a type of disease that occurs when the body makes too many immature Langerhans cells (a type of white blood cell). When these cells build up, they can form tumors in certain tissues and organs including bones, skin, lungs and pituitary gland and can damage them. This tumor is more common in children and young adults. DAY101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Using DAY101 may be effective in treating patients with relapsed or refractory Langerhans cell histiocytosis.
• 180 days to < 22 years (at time of study enrollment)
• patients with multifocal progressive, relapsed, or recurrent LCH with measurable disease at study entry
• participant must be able to take an enteral dose and formulation of medication. Study medication is only available as an oral suspension or tablet, which may be taken by mouth or other enteral route such as nasogastric, jejunostomy, or gastric tube
• see link to clinicaltrials.gov for complete inclusion criteria
• LCH arising along with other hematologic malignancy (e.g. mixed LCH with acute lymphoblastic leukemia) or any history of non-histiocytic malignancy
• history of solid organ or hematopoietic bone marrow transplantation
• female patients who are pregnant are ineligible. A pregnancy test is required for female patients of childbearing potential
• lactating females who plan to breastfeed their infants are ineligible
• see link to clinicaltrials.gov for complete exclusion criteria
Balance4Mobility: Effects of Walkasins Use on Clinical Outcomes of Gait and Balance Function in Individuals with Peripheral Neuropathy and Balance Problems – A Randomized Control Trial
The main purpose of this study is to test whether Walkasins can help people with peripheral neuropathy maintain their balance better. Walkasins have been developed to improve balance and walking by enhancing a person’s ability to feel the pressure beneath his/her feet as he/she walks.
• at least 55 years old
• able to complete all activities without the use of an assistive device
• diagnosis of peripheral neuropathy (if due to chemotherapy, must be 1 year after completion)
• experiencing problems with gait or balance
• able to stand on one leg for at least 30 seconds
• acute thrombophlebitis, including deep vein thrombosis, or severe peripheral vascular disease
• lymphedema
• swelling, infection, inflamed area of skin or eruptions on the lower leg
• weigh more than 300 pounds
PEPN2415; A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD1390 (NSC# 852149, IND# 172675) when Combined with Focal Radiation in Pediatric Patients with High Grade Glioma
The primary purpose of this study is to define the recommended Phase 2 dose of AZD1390 when given in combination with radiation for pediatric supratentorial and infratentorial high-grade gliomas. The toxicities, safety profile and pharmacokinetic profile of AZD1390 in this setting will also be assessed.
• For the dose escalation phase, patients must be ≥ 12 months and < 18 years of age at the time of study enrollment.
• For the disease expansion phase, patients must be ≥ 12 months and < 22 years of age at the time of study enrollment.
• Patients with newly diagnosed primary High-Grade Glioma, Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma who are eligible to receive 54-59.4 Gy fractionated radiation at 1.8 Gy/day.
• Patients must have had histologic verification of malignancy at original diagnosis except in patients with DIPG.
• Patients who are pregnant or breast-feeding.
• Patients who are currently receiving another investigational drug.
• Patients receiving prior therapy for any cancer diagnosis (including radiation) is not allowed with the exception of surgery and/or corticosteroids.
• Patients who are currently receiving other anti-cancer agents are not eligible with the exception of corticosteroids.
• Anti-GVHD agents post-transplant: Patients who are receiving anti-graft-versus-host disease post bone marrow transplant.
S1905; A Phase I/II Study of AKR1C3-Activated Prodrug OBI-3424 (OBI-3424) In Patients with Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL)/T-Cell Lymphoblastic Lymphoma (T-LBL)
This phase II trial studies how well OBI-3424 works in treating patients with T-cell acute lymphoblastic leukemia that has come back (relapsed) or does not response to treatment (refractory). Drugs used in chemotherapy, such as OBI-3424, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. OBI-3424 may reduce the amount of leukemia in the body.
• Age: >= 12 years of age.
• Diagnosis of relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) based on WHO classification or relapsed/refractory T-cell lymphoblastic lymphoma if lymphoblasts are >= 5% in the bone marrow or in the peripheral blood by morphology or flow cytometry.
• Evidence of acute leukemia in their peripheral blood or bone marrow; >= 5% lymphoblasts.
• Patients >= 18 years of age must be refractory to or have relapsed following a standard induction chemotherapy. - Patients <18 years of age must have relapsed or must be refractory after 2 or more chemotherapy cycles.
• Received chemotherapy or investigational agents within 14 days prior to registration.
• Experiencing toxicities from radiation therapy.
• Undergone allogeneic hematopoietic transplant within 90 days prior to registration.
• Evidence of active ≥ Grade 2 acute graft versus host disease (GVHD) or moderate or severe limited chronic GVHD
• No uncontrolled systemic fungal, bacterial, viral or other infection.
HM2024-36 A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF QUIZARTINIB ADMINISTERED IN COMBINATION WITH INDUCTION AND CONSOLIDATION CHEMOTHERAPY AND ADMINISTERED AS MAINTENANCE THERAPY IN ADULT PATIENTS WITH NEWLY DIAGNOSED FLT3-ITD NEGATIVE ACUTE MYELOID LEUKEMIA (QuANTUM-WILD)
The purpose of this research is to test how well the investigational study drug, quizartinib, works in patients with AML without a FLT3-ITD mutation who have not received any prior treatment for the disease. The study will test how it works when taken with standard chemotherapy and then taken alone to prevent the disease from coming back.
• 18 to 70 years old
• newly diagnosed, primary Acute Myeloid Leukemia (AML)
• at least able to walk do selfcare but may be unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete Inclusion criteria
• any other type of leukemia
• AML caused by prior chemotherapy or radiotherapy or myelodysplastic syndrome (MDS)
• prior treatment for leukemia, with some exceptions
• see link to clinicaltrials.gov for complete Exclusion criteria
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
D2D Collection of microbes from the oral cavity using the oral rinse method
Microbes in the oral cavity can cause diseases such as cavities and infected root canals. One genus of bacteria, Enterococcus, is also commonly found in the gastrointestinal tract and as an opportunistic pathogen in healthcare-associated infections. Currently, there are very few isolates of Enterococcus species that have been obtained from the oral cavity. Enterococcus species can interact with other oral microbes, including bacteria, fungi, and bacteriophage, and this may contribute to the development of oral infections. We seek to collect oral isolates of Enterococcus, Streptococcus, bacteriophages, and fungi like Candida albicans to further our research on biofilm development and virulence of these bacteria. In this study, oral rinse samples will be collected from adults at the MN State Fair for isolation of microbes and sequencing of microbial DNA. This study is only available at the D2D Building at the Minnesota State Fair.
• all adults are eligible
ConnectedNest: a digital platform connecting individuals with cancer to social care
Social determinants of health (SDoH) like housing instability, food insecurity, and financial burden, for example, can negatively affect people dealing with cancer. With new cancer treatments and higher costs for patients, people dealing with cancer may worry more about those issues. The goal of this study is to compare the ways people with cancer are connected to resources addressing specific needs and how those connections help their overall well-being. The research study will take about five months and participants will spend around one hour on research activities (each survey would take less than 15 minutes). The time you spend following up on helpful resources is completely up to participants.
• undergoing active cancer therapy or in survivorship
• must be able to read and write in English
• seen in a participating Minnesota oncology clinic
• children
Protocol M23-716: A Phase 3 randomized, placebo-controlled, double-blind program to evaluate efficacy and safety of upadacitinib in adult and adolescent subjects with severe alopecia areata
This study will assess how effective and safe the use of the medication named Upadacitinib is for the treatment of signs and symptoms of severe hair loss in adults.
• 12-63 years of age
• have more than 50% hair loss
• pregnancy
Longitudinal characterization of the role of the mucosal virome and microbiome in juvenile idiopathic arthritis flares
The goal of this observational study is to learn more about associations between respiratory infections, changes in the microbiome of the nose and upper throat, and juvenile idiopathic arthritis (JIA).
• Presence of a condition or abnormality that would compromise the safety of the participant or the quality of the data (e.g., parent not able to answer the questionnaire because of a psychological condition or an anxiety disorder that is severe).
• Contraindication for routine mucosal specimen collection (e.g. bleeding disorder, etc.).