
Search Results
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
MT2021-26: Ruxolitinib for Early Lung Dysfunction after HSCT: a Phase II Study (HSCT)
While hematopoietic stem cell transplant (HSCT) is an effective therapy, as many as 25% of patients develop problems with their lungs as a result of this treatment. Bronchiolitis obliterans (BO) is a type of lung injury after HSCT due to graft versus host disease. BO is commonly diagnosed late in patients, when lung injury is hard to treat and can be irreversible, leading to long-term lung disease or even death. The purpose of this research is to learn more about ruxolitinib as an early treatment for lung injury and BO after HSCT. Patients who are diagnosed with early lung dysfunction will be eligible for this research study.
• 5 to 60 years old
• undergone allogeneic HCT and experiencing respiratory difficulty
• if able to become pregnant or father a child, must use two highly effective methods of birth control for 90 days after the last dose of study drug
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• active uncontrolled pulmonary infection
• women who are pregnant or breast feeding
• treated with investigational agent for GVHD within the 30 days prior to first dose of study treatment
MT2024-42: Phase 1b Dose Expansion/2 Study of NXC-201 for the Treatment of Patients with Relapsed or Refractory AL Amyloidosis (NEXICART-2)
The purpose of this study is to find the best dose of NXC-201 to treat AL amyloidosis. The people in this study have AL amyloidosis that came back or does not get better with treatment. NXC-201 is a cellular therapy made from your own white blood cells called T cells. If you join this study, we will collect some of your T cells and modify (change) them in a lab. This modification will help your T cells find and kill abnormal plasma cells. These genetically changed T cells are called chimeric antigen receptor (CAR) T cells. NXC-201 is a CAR T cell therapy and is given intravenously (by vein). To prepare your body for NXC-201, you will also get fludarabine and cyclophosphamide, which are chemotherapy drugs. After you get NXC-201, you will be in the hospital for at least 10 days.
• walking and able to do selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• proven diagnosis of systemic AL amyloidosis
• have symptoms of organ involvement (heart, kidney, liver/GI tract, peripheral nervous system)
• able to swallow pills
• see link to clinicaltrials.gov for complete Inclusion criteria
• prior treatment with CAR T therapy
• stroke or seizure within past 6 months
• significant heart disease
• women who is pregnant, or breastfeeding, or planning to become pregnant
• unwilling to practice effective birth control
• see link to clinical trials.gov for complete Exclusion criteria
HM2021-31: A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination with Other Anti-cancer Agents in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)
The purpose of this study is to evaluate if the investigational combination of drug called loncastuximab tesirine in combination with another anti-cancer agent is a safe and effective treatment for patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma.
• diagnosis of relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) B-Cell Non-Hodgkin Lymphoma (B-NHL)
• able to walk and capable of 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
• previous treatment with polatuzumab vedotin, glofitamab or mosunetuzumab
• stem cell transplant within 60 days prior to start of study drug
• Human immunodeficiency virus (HIV) seropositive
• women who are pregnant or breast feeding
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 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
AALL2321; A Phase 2 Study of Blinatumomab in Combination with Chemotherapy for Infants with Newly Diagnosed Acute Lymphoblastic Leukemia with Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax
To evaluate the addition of two cycles of blinatumomab for all infants with newly diagnosed ALL and will evaluate in a randomized manner the safety, tolerability, and early activity of venetoclax in infants with KMT2A-R ALL.
• Eligibility Screening: All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to treatment and enrollment on AALL2321.
• Age: Infants (aged 365 days or less) on the date of diagnosis are eligible; infants must be > 36 weeks gestational age at the time of enrollment.
• Diagnosis: Patients must have newly diagnosed B-acute lymphoblastic leukemia (B-ALL, 2017 WHO classification), also termed B-precursor ALL, or acute leukemia of ambiguous lineage (ALAL), which includes mixed phenotype acute leukemia. For patients with ALAL, the immunophenotype of the leukemia must comprise at least 50% B lineage.
• Patients with Down Syndrome.
• Patients with secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy.
• Prior therapy: Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of infant ALL or for any cancer diagnosis prior to the initiation of protocol therapy.
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.
MT2023-46: A Phase 3, multicenter, randomized, open-label, parallel group, treatment study to assess the efficacy and safety of the lifileucel (LN-144, autologous tumor-infiltrating lymphocytes [TIL]) regimen in combination with pembrolizumab compared with pembrolizumab monotherapy in participants with untreated, unresectable or metastatic melanoma
We want to find out whether lifileucel is safe and works in treating untreated, unresectable or metastatic melanoma. Lifileucel is a type of medicine, known as immunotherapy, that uses your body’s immune system to fight cancer. Lifileucel is also called “tumor infiltrating lymphocytes” (TIL) and is made up of specialized white blood cells known as lymphocytes or “T cells” obtained from a piece of your tumor. T cells are a part of your immune system that help your body fight against infections and diseases including fight cancer.
• 18 to 70 years old (in certain cases, people older than 70 may be able to enroll)
• diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma
• may not be able to do physically strenuous activity but walking and able to do light or sedentary work, e.g., light house work, office work
• participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control
• see link to clinicaltrials.gov for complete Inclusion criteria
• melanoma of uveal/ocular (eye) origin
• symptomatic untreated brain metastases
• had another cancer in the previous 3 years
• history of allogeneic cell or organ transplant
• see link to clinicaltrials.gov for complete exclusion criteria
MT2024-33 A Phase 1/2a Multicenter Ascending Dose Study to Evaluate the Safety of HA-1 Minor Histocompatibility Antigen-Reactive TCR-Modified T Cells (BSB-1001) in Patients Undergoing HLA-Matched Allogenic Hematopoietic Stem Cell Transplant for AML, ALL or MDS
This study is designed to determine whether BSB-1001 - a product made of genetically modified cells - is safe and possibly effective when given to patients with Acute Myelogenous Leukemia (AML), Acute Lymphocytic Leukemia (ALL), or Myelodysplastic Syndrome (MDS) who are also receiving a stem cell transplant with a matched donor.
• ages 18 - 70 years inclusive, having a alloHCT.
• any of the following high-risk hematologic malignancies: • AML which has been treated with at least two lines of therapy, and refractory or relapsed • ALL • MDS after at least one line of therapy, which includes hypomethylating agent(s) and venetoclax and must be high or very high risk • AML patients who have been treated with at least two lines of therapy, and refractory or relapsed
• suitable for one of the approved conditioning regimens as defined in the protocol
• must have an identified donor that is HA 1-negative with 10/10 matched related donor or 12/12 matched unrelated donor
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• weight \> 100 kg. (220 lbs)
• prior history of allogeneic or autologous stem cell transplantation
• previous genetically engineered chimeric antigen receptor T Cell therapy (CAR-T), approved or investigational, within 2 years of screening, with the exception of patients with ALL previously treated with an autologous CAR-T product.
• recent treatment with other investigational agents
• history of treatment with checkpoint inhibitor therapy within 3 months of transplantation
• women who are pregnant or breast feeding
• uncontrolled bacterial, viral, or fungal infections
• CNS involvement that hasn't responded to intrathecal chemotherapy and/or standard cranial- spinal radiation.
• unable to work; able to live at home and care for most personal needs; requires occasional assistance, but is able to care for most personal needs or better performance
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
MT2022-52: Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) with Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases
Stem cell transplants (sometimes referred to as a bone marrow transplants) have been done for over 40 years but research continues to further refine the method to reduce side effects without affecting transplant success. The purpose of this study is to improve on transplant outcomes while reducing the potential side effects based on what has been learned from previous transplant studies using a reduced intensity preparative regimen. Information collected during this study (transplant outcomes and side effects) will be compared with the outcomes of the previous reduced intensity conditioning transplant study that enrolled more than 300 patients since 2002.
• up to 75 years of age
• have a matched related donor
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• women who are pregnant or breast feeding
• active central nervous system malignancy
• untreated active infection
• additional criteria for exclusion (study staff will review)
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
D2D: State Fair on Tap
This study is about the patterns and characteristics of how individuals drink alcohol, especially at events like the state fair. This study is only available at the Minnesota State Fair in the D2D Building.
• at least 21 years old
• consumed alcohol in the past month
• plan to drink at the fair (or already have)
• have a smartphone
• women who report being pregnant
• people who don't consume alcohol
HM2023-43: A phase 2 trial of tafasitamab in combination with lenalidomide+rituximab in treatment-naive follicular lymphoma and marginal zone lymphoma
This study is to see if patients who get tafasitamab in addition to the standard regimen of lenalidomide and rituximab when they are just starting treatment are more likely to stay in remission after treatment than those who do not. We expect that participants will be in this research study for approximately 3 years total. Patients will be on active treatment for approximately 1 year.
• confirmed marginal zone lymphoma
• have not received systemic therapy for lymphoma
• need treatment because of bulky disease, associated symptoms, or causing problems with vital organs (heart, spleen, lung)
• see link to clinicaltrials.gov for complete Inclusion criteria
• active HIV, Hepatitis B, Hepatitis C
• prior history of lenalidomide use
• history of another cancer in the past 5 years
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
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
HM2024-18 A Phase 1/2, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-3654 in Patients with Intermediate or High-risk Primary or Secondary Myelofibrosis
This study is testing an compound called TP-3654, which is an investigational product being developed for Myelofibrosis.
• diagnosis of primary or secondary myelofibrosis
• may be restricted from 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 complete inclusion criteria which are specified by diagnosis
• eligible for allogeneic bone marrow or stem cell transplantation
• history of symptomatic congestive heart failure, or myocardial infarction, or uncontrolled arrhythmia within the past 6 months
• history of chronic liver disease
• women who are pregnant or breastfeeding -see link to clinicaltrials.gov for complete exclusion criteria which are specified by diagnosis
HM2017-24 : Phase I/II Study of Nivolumab in Combination with Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma: BTCRC-HEM-027
Participants who take part in this study will receive a study drug called ruxolitinib with a standard drug called nivolumab. The study is being done to measure the percentage of tumor (lymphoma) that shrinks after receiving ruxolitinib in combination with nivolumab. This study will also measure the length of time the lymphoma is inactive and how safe the combination is to administer to participants. Ruxolitinib is a pill that is taken twice every day. Nivolumab is given as an infusion in the clinic once every 4 weeks.
• age 18 or older
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• confirmed diagnosis of classical Hodgkin lymphoma that has reoccurred or not responded to treatment
• women and men who are of child bearing age must use required birth control
• there are additional criteria for prior treatment and laboratory results (study staff will review)
• inability to swallow oral medication or any condition that affects absorption of oral medications
• women who are pregnant or breast feeding
• additional criteria about current medical history (study staff will review)
A Randomized Double Blind Phase II Trial of Restorative Microbiota Therapy (RMT) or Placebo in Combination with Durvalumab (MEDI4736) and Tremelimumab With Chemotherapy in Treatment Naïve Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer
The investigational therapy in this study is referred to as Restorative Microbiota Therapy (RMT). It is prepared by extracting healthy bacteria from the stool of healthy human donors and making it into capsules taken by mouth. The donor stool samples are rigorously tested for harmful bacteria and viruses before processing. There is scientific evidence to suggest that RMT might make immunotherapy more effective. The primary goal of the study is to test if RMT makes durvalumab + tremelimumab treatment with chemotherapy more effective to control lung cancer.
• confirmed adenocarcinoma of the lung that is stage IIIB/C or stage IV that can't be surgically removed
• prior chemotherapy or immunotherapy as adjuvant therapy for lung cancer is permitted as long as it has been more than 6 months from last dose
• people who have treated brain metastasis are eligible as long as they have stable symptoms, are more than 2 weeks from completion of therapy, and do not require more than 10mg of daily prednisone or equivalent
• restricted in strenuous physical activity but can walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• weigh at least 30 kg (66 lbs.)
• contact study staff for additional requirements
• women who are pregnant or breast feeding
• unable to swallow medications
• additional medical and mental health diagnosis (study staff will review)
Non-Invasive Sleep and Circadian Rhythm Assessment Pre- and Post-surgery in Cushing Disease
The goal of this study is to see if using in-home sleep activity monitoring may help understand sleep problems that occur before and after surgical treatment for Cushing Disease.
• Aged 18 years or older
• Their own legal guardian
• Confirmed Cushing's Disease (CD) by biochemical test and brain MRI imaging
• Scheduled for surgery to treat CD
• Receiving care through an Endocrinology or Neurosurgery clinic
• Able to complete the self-report their health/wellbeing and sleep diary information
• Biochemical and/or brain MRI imaging test with inconclusive results
• Patients not electing for surgical intervention for CD
Development of a RET-Specific Proteomic Assay from Circulating Tumor Cells in Lethal Prostate Cancer
The goal of this study is to find a special protein in the blood of individuals with serious prostate cancer. Special tests look for this protein in their blood while they are getting their regular cancer treatments.
• diagnosis of metastatic castration resistant prostate cancer receiving a standard-of-care systemic therapy (e.g. abiraterone acetate, enzalutamide, darolutamide, or chemotherapy).
• known HIV positivity and/or active Hepatitis B based on medical history
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
MT2022-49: Early identification of cognitive side-effects of immunotherapy
This study is testing different ways to look for neurologic side effects in patients who get CAR-T therapy for their cancer.
• planning to have inpatient CAR-T therapy for primary cancer
• fluent in English (written or spoken)
• presence of speech or hearing problem
• diagnosis of cognitive impairment
MT2015-29 : Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Adult Unrelated Donor for the Treatment of Hematological Disorders
The primary research element is to determine whether a graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide, tacrolimus and MMF will reduce the likelihood of chronic GVHD in patients receiving a standard hematopoietic myeloablative stem cell transplant. The treatment related components of this protocol are established clinical practices. We are looking at cumulative incidence of chronic GVHD requiring systemic immunosuppressive treatment at 1 year post-transplant.
• no more than 60 years old
• may be unable to work; able to live at home and care for self
• women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria (differ by diagnosis)
• if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If >18 years old prior myeloablative allotransplant or autologous transplant
• active central nervous system cancer
• active HIV infection or known HIV positive serology
• active uncontrolled infection
• women who are pregnant or breast feeding
MT2024-07:A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Subjects with Active Systemic Lupus Erythematosus (RESET-SLE)
The purpose of this study is to find out what dose of CABA-201 can be safely administered to patients with SLE, including those with lupus nephritis (LN). SLE is thought to involve B cells that cause the body to attack different tissues in the body including your skin, joints, kidneys, heart, lungs, brain, and blood cells. LN is a type of kidney disease caused by SLE. CABA-201 is a chimeric antigen receptor T cell (CAR T) therapy. In this study, we will take some of your T cells, a type of white blood cell, and genetically modify them (put in a “code”) so that they may find and remove the B cells in your body, including the B cells that are involved in causing your disease. Once your cells are modified, CABA-201 cells will be re-infused into your body intravenously (through the vein).
• 18 to 65 years old
• diagnosis of Systemic Lupus Erythematosus (SLE)
• positive antinuclear antibody (ANA) titer or anti-dsDNA antibody
• active infection requiring medical intervention
• presence of kidney disease other than active lupus nephritis
• prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant.
• additional medical conditions (study staff will review)
D2D Care Aware: Understanding Opioids in Minnesota
This study is available at the Minnesota State Fair. According to the Minnesota Department of Human Services, about 290,000 adults in Minnesota need treatment for addiction. National data suggests that only 10% of those who need treatment receive it. The goal of the study is to determine public opinion and knowledge about opioid use disorder and its treatment.
• at least18 years of age
• able to provide informed consent
A Phase 2, Randomized, Controlled, Multicenter Study of Vosoritide in Children With Idiopathic Short Stature (ISS)
This research is being done to learn if a study drug called vosoritide can help children who are shorter than should be for their age to grow.
• 3 to 10 years old if a girl
• 3 to 11 years old if a boy
• have short stature compared to others of the same gender and age with no known cause
• able to move and stand without help
• known chromosomal imbalance or genetic variant causing short stature syndrome
• previous treatment with a growth promoting agent
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
ANBL2131/MT2024-35- A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma
This phase III trial tests how well adding dinutuximab to induction chemotherapy along with standard of care surgery radiation and stem cell transplantation works for treating children with newly diagnosed high risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found in greater than normal amounts on some types of cancer cells. This helps cells of the immune system kill the cancer cells. Chemotherapy drugs such as cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, dexrazoxane, doxorubicin, temozolomide, irinotecan and isotretinoin, 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. During induction, chemotherapy and surgery are used to kill and remove as much tumor as possible. During consolidation, very high doses of chemotherapy are given to kill any remaining cancer cells. This chemotherapy also destroys healthy bone marrow, where blood cells are made. A stem cell transplant is a procedure that helps the body make new healthy blood cells to replace the blood cells that may have been harmed by the cancer and/or chemotherapy. Radiation therapy is also given to the site where the cancer originated (primary site) and to any other areas that are still active at the end of induction.
• Must have a diagnosis of NBL or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamines
• Newly diagnosed, HRNBL defined as one of the following: a. Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M and MYCN amplification b. Age:: greater than or equal to 547 days and INRG Stage M regardless of biologic features c. Any; age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to Stage M without systemic chemotherapy d. Age: greater than or equal to 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to Stage M without systemic chemotherapy BSA: Patients must have a BSA greater than or equal to 0.25 m2
• Patients who are 365-546 days of age with INRG Stage M and MYCN non-amplified NBL, irrespective of additional biologic features.
• Patients ≥547 days of age with INRG Stage L2, MYCN non-amplified NBL, regardless of additional biologic features.
• Patients with known bone marrow failure syndromes.
• Patients on chronic immunosuppressive medications
• Patients with a primary immunodeficiency syndrome who require ongoing immune globulin replacement therapy.
• Female patients who are pregnant or breastfeeding their infant.
Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis
This study is comparing the treatment of Non-Alcoholic Steatohepatitis (NASH) with either lifestyle changes or obesity surgery with lifestyle changes. Participants must be 30-70 years old, have a BMI of 35.0-60.0 kg/m2, have health insurance that will pay for obesity surgery, and be willing to accept either treatment.
• ages 30 to 70 years
• diagnosed with NASH with a total NAS >=4 including a ballooning score of at least 1, or diagnosed with T2DM or prediabetes, HbA1c < 9% Body Mass Index (BMI): 35.0-50.0 kg/m2
• willing to accept either surgery or life style changes
• must have insurance with no exclusion for obesity related treatments or management of obesity surgery complications. applies to all participants enrolled in the study
• evidence of liver fat present in the baseline MR images
• suitable for liver biopsy
• cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months
• pulmonary embolus or thrombophlebitis in the past six months
• cancer diagnosis unless disease free for five years
• alcohol intake more than one drink per day
• other physical or mental health disease (study staff will review)