[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Masonic Cancer Center, University of Minnesota\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":664},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,35,0,25,[9,42,66,89,111,133,159,177,202,248,274,317,344,374,395,417,441,463,485,510,530,577,601,622,644],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100577017","phase-2-hm2023-43ph-2-trial-of-tafasitamab-with-lenalidomiderituximab-in-treatment-naive-fl-and-mzl-100577017",false,"NCT06792825","HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL","HM2023-43: A Phase 2 Trial of Tafasitamab in Combination With Lenalidomide+Rituximab in Treatment-naive Follicular Lymphoma and Marginal Zone Lymphoma","Inclusion Criteria:\n\n* Histologically confirmed marginal zone lymphoma\n* Histologically confirmed CD20+ follicular lymphoma stage 1, 2 or 3a\n* No prior systemic therapy for lymphoma\n* Must be in need of treatment as evidenced by one or more of the following criteria:\n* Bulky disease defined as:\n* a nodal or extranodal (except spleen) mass \\>7cm in its greater diameter or,\n* involvement of at least 3 nodal or extranodal sites (each with a diameter greater than \\>3 cm)\n* Presence of at least one of the following B symptoms:\n* fever (\\>38C) of unclear etiology\n* night sweats\n* weight loss greater than 10% within the prior 6 months\n* Any other symptoms attributable to lymphomatous mass\n* Endangerment of vital organ due to lymphomatous mass including but not limited to:\n* Symptomatic or massive splenomegaly\n* Compression syndrome (including but not limited to ureteral, orbital, gastrointestinal)\n* Pleural, pericardial or ascitic effusion regardless of cell count\n* Follicular lymphoma in leukemic phase (\\>5 X 109\u002FL circulating cells)\n\nOR:\n\n* Follicular lymphoma graded high-risk by FLIPI2 score (see Appendix III)\n* Adequate organ function within 14 days (28 days for pulmonary or cardiac) of study registration\n* Participants who are of childbearing potential or have partners of child-bearing potential must agree to either total abstinence or use of both a highly effective (IUD, hormonal contraceptives, tubal ligation or vasectomy), and effective contraception (male or female condom, diaphragm or cervical cap) for the duration of treatment and for 12 months after the last dose of study drug.\n* Able to tolerate prophylactic anticoagulation\u002Fantiplatelet therapy while on lenalidomide\n* Able to provide written voluntary consent prior to the performance of any research related tests or procedures (or the subject's legally authorized representative (LAR) if enrollment of persons with diminished capacity is permitted - general permitted for Phase II and greater studies)\n\nExclusion Criteria:\n\n* Seropositive for or active viral infection with hepatitis B virus (HBV):\n* HBV surface antigen (HBsAg) positive\n* HBV surface antigen (HBsAg) negative, HBV surface antibody (anti-HBs) positive and\u002For HBV core antibody (anti-HBc) positive, and detectable viral DNA\n* Hepatitis C virus (HCV) positive subjects with chronic hepatitis C, or subjects with an active hepatitis C infection requiring anti-viral medication (at time of randomization).\n* Known seropositive for or active viral infection with human immunodeficiency virus (HIV).\n* Prior history of lenalidomide use\n* Prior history of malignancies, other than follicular or marginal zone lymphoma, unless the subject has been free of the disease for ≥ 5 years.\n* Peripheral neuropathy ≥ grade 2 at time of screening\n* Uncontrolled intercurrent illness.\n* Active infection (requiring systemic therapy) or has received a live vaccine within 14 days prior to first dose of study drug.\n* Presence or history of CNS involvement by lymphoma\n* Patients who are not willing to take venous thromboembolic (VTE) prophylaxis or antiplatelet therapy\n* Recent ( \\\u003C1 year ) arterial thrombosis (any) or venous thrombosis ≥ grade 3 by CTCAE 5.0.\n* Pregnant or breastfeeding as agents used in this study are Pregnancy Category X.\n\nWomen of childbearing potential must have two negative pregnancy tests (serum or urine) prior to their first dose of lenalidomide, and must agree to scheduled pregnancy testing while on treatment regardless of their birth control choice, per the requirements of the lenalidomide risk evaluation and mitigation strategy (REMS) program.","ALL","18 Years",{"count":20,"type":21},65,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The study follows a Simon's two-stage phase II trial design to evaluate the safety and efficacy of tafasitamab added to rituximab and lenalidomide for two treatment-naïve, parallel, independent cohorts: follicular lymphoma (FL) and marginal zone lymphoma (MZ). Each cohort, FL and MZ, will be evaluated separately. This study is presented to the patient and consent is signed prior to the initiation of treatment for their primary malignancy.",[27,28],"Follicular Lymphoma","Marginal Zone Lymphoma","RECRUITING","2026-08-10",{"date":32,"type":33},"2026-08-12","ACTUAL",{"date":35,"type":33},"2025-08-07",{"date":37,"type":21},"2031-07-08",{"name":39,"class":40},"Masonic Cancer Center, University of Minnesota","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":41},"100561036","rural-smoking-cessation-100561036","NCT06584929","Rural Smoking Cessation","Evaluating Population-Based Strategies for Rural Smoking Cessation","Inclusion Criteria:\n\n* ≥ 21 years\n* smoke ≥ 5 cigarettes per day\n* daily access to their own iPhone\u002FAndroid smartphone or tablet\n\nExclusion Criteria:\n\n* past 30-day NRT use or contraindications listed on the NRT labels\n* currently pregnant\u002Fbreastfeeding",true,"21 Years",{"count":52,"type":21},544,[54],"NA","Understanding ways to help people who live in rural areas quit smoking is a public health priority. quitting smoking among rural people who smoke is a critical public health concern. People in rural areas smoke at higher rates than those in urban areas, experience high rates of smoking caused cancers and deaths. We are recruiting rural people from around the country to better understand how different quit smoking methods can improve a person's chances of successfully quitting smoking.",[57],"Smoking Cessation","2026-07-24",{"date":60,"type":33},"2026-07-27",{"date":62,"type":33},"2026-03-17",{"date":64,"type":21},"2029-08-31",{"name":39,"class":40},{"id":67,"slug":68,"hasResults":12,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":41},"100593607","phase-1-phase-iii-clinical-trial-of-proteasome-inhibitor-in-combination-with-cpx-351-for-the-treatment-of-newly-diagnosed-tp53-mutated-acute-myeloid-leukemia-aml-100593607","NCT07008638","Phase I\u002FII Clinical Trial of Proteasome Inhibitor in Combination With CPX-351 for the Treatment of Newly-Diagnosed TP53-mutated Acute Myeloid Leukemia (AML)","HM2024-29: Phase I\u002FII Clinical Trial of Proteasome Inhibitor in Combination With CPX-351 for the Treatment of Newly-Diagnosed TP53-mutated Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* Adult (age ≥ 18 years at time of consent)\n* Have not received any systemic chemotherapy for the treatment of AML. Use of hydroxyurea and leukapheresis to control excess peripheral blasts is permissible. WBC \\\u003C 25,000 to initiate bortezomib, must reach this threshold by day 7 of CPX-351.\n* Karnofsky performance status (KPS) ≥ 70\n* Adequate renal, hepatic and cardiac function defined as\n* Renal: An estimated glomerular filtration rate ≥ 30 mL\u002Fmin\u002F1.73 m2\n* Hepatic: AST and ALT ≤3 x ULN, ALP ≤2.5 x ULN, and total bilirubin ≤1.5 x ULN. (exception for Gilbert's syndrome or leukemic infiltration of liver)\n* Cardiac: New York Heart Association (NYHA) Class I or II, left ventricular ejection fraction \\> 50% by echocardiogram, MUGA or cardiac MRI\n* Sexually active couples of childbearing potential must agree to use effective contraception or abstinence during treatment and for at least 7 months after the final dose of study drug\n* Provides voluntary written consent before the performance of any study related activities not part of standard of care.\n\nExclusion Criteria:\n\n* Received systemic chemotherapy for the treatment of AML\n* Bi-phenotypic acute leukemia or mixed lineage leukemia, acute promyelocytic leukemia\n* Active central nervous system malignancy or symptoms of CNS involvement\n* Symptomatic extramedullary disease\n* Known history of uncontrolled HIV or active hepatitis B or active hepatitis C infection\n* Has any of the following cardiac abnormalities\n* Symptomatic congestive heart failure\n* Myocardial infarction less than or equal to 6 months prior to enrollment\n* Unstable angina pectoris\n* Serious uncontrolled cardiac arrhythmia\n* Concomitant malignancies or previous malignancies with less than a 1-year disease free interval at the time of signing consent. Potential participants with adequately resected basal or squamous cell carcinoma of the skin, or adequately resected carcinoma in situ (e.g., cervix) may enroll irrespective of the time of diagnosis\n* Participants for whom administration of CPX-351 would exceed their lifetime cumulative daunorubicin exposure limit of 550 mg\u002Fm2 (or 400 mg\u002Fm2 in patients with prior chest radiation) or equivalent anthracycline dose.\n* Pregnant or breastfeeding, or planning pregnancy within 3 months after the treatment completion",{"count":74,"type":21},32,[76,24],"PHASE1","This is a Phase I\u002FII study evaluating safety and efficacy of proteasome inhibitor (bortezomib) in combination with CPX-351 (liposomal daunorubicin and cytarabine) for the treatment of newly-diagnosed TP53-mutated acute myeloid leukemia (TP53m AML).\n\nThe primary endpoint of the study is to define safety\u002Ftolerability (phase I) and preliminary efficacy profile (phase II) of the treatment. The secondary endpoints of interest are complete remission (CR) rate, detectable minimal residual disease (MRD) status, overall response rate (ORR), rate of allogeneic hematopoietic cell transplantation (allo-HCT), treatment-related mortality (TRM), overall survival (OS), achievement of complete remission anytime in 1 year, and disease-free survival (DFS) at 1 year and 2 years. All the patient outcomes assessments will be performed as part of standard-of-care AML management.\n\nThe hypothesis is the combination of bortezomib and CPX-351 will have an acceptable safety profile in this patient population based on the data from previous studies. The treatment will attenuate Nuclear Factor kB pathway activation in these cells and eradicate TP53m leukemia stem cells (LSC) leading to increased response rate and survival in these patients.",[79,80],"Acute Myeloid Leukemia","TP53","2026-07-21",{"date":83,"type":33},"2026-07-22",{"date":85,"type":33},"2025-07-07",{"date":87,"type":21},"2028-01-27",{"name":39,"class":40},{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":49,"sex":17,"minAge":18,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":105,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":41},"100514067","role-of-acetaldehyde-in-the-development-of-oral-cancer-100514067","NCT05973656","Role of Acetaldehyde in the Development of Oral Cancer","Dissecting the Role of Acetaldehyde in Oral Carcinogenesis","Inclusion Criteria:\n\n* 21-45 years of age for alcohol drinkers\n* Occasionally consume alcohol\n* At least 1 drink per month for healthy volunteers\n* At least 1 drink in the last 3 months for Fanconi anemia patients\n* Meets one of the three criteria\n* Healthy volunteer - ALDH2\\*1\u002F1\\* homozygotes-not of Eastern Asian decent;\n* Healthy volunteer - ALDH2\\*1\u002F2\\* heterozygotes-of Eastern Asian decent and experience flushing when drinking\n* Individual's with Fanconi anemia (FA).\n* 18-45 years of age for non-drinkers\n* Never consume alcohol\u002Fnot had alcohol in the last 6 months\n* Healthy volunteers.\n* Non-smoker (smoked \\\u003C 100 cigarettes in a lifetime)\n\nExclusion Criteria:\n\n* Pregnant or nursing\n* Taking any medication or drug that might affect alcohol use and absorption or that might be affected by alcohol consumption\n* Healthy volunteers who have taken any antibiotics in the last 3 months\n* Currently consuming more than 21 drinks per week\n* Have any history of alcohol or drug related problems\n* Current or former tobacco\u002Fnicotine product(s) user\n* Any regular use of tobacco\u002Fnicotine products or marijuana in the last year (cigarettes, e-cigarettes, cigars, pipes, smokeless tobacco)\n* \"Trying\" or limited use of any nicotine products or marijuana in the last 1 month\n* Active infection (influenza, cold, COVID, respiratory \u002F sinus infection) - admission in the study will be delayed pending improved health\n* Non-FA volunteers who have an unstable medical condition or condition that could be affected by alcohol consumption (insulin-dependent diabetes, ulcers, heart issues)\n* Experience severe adverse events (nausea, blacking out) when consuming even low doses of alcohol","45 Years",{"count":98,"type":21},170,[54],"This is a minimal risk intervention study where healthy volunteers and individuals with Fanconi anemia will consume a single dose of alcohol and provide primarily non-invasive biological samples at various time points. Biospecimens to be collected include saliva, oral cells collected via mouthwash and cheek brush, and urine. The collection of two blood samples (5 mL each) will be optional and banked for future use.",[102,103,104],"Alcohol-Related Carcinoma","Fanconi Anemia","Oral Cavity Carcinoma",{"date":83,"type":33},{"date":107,"type":33},"2022-07-08",{"date":109,"type":21},"2027-09-30",{"name":39,"class":40},{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":41},"100561767","phase-1-hm2023-05-gtb-3650-trike-for-high-risk-mds-and-rr-aml-100561767","NCT06594445","HM2023-05: GTB-3650 Trike for High Risk MDS and R\u002FR AML","HM2023-05: GTB-3650 (Anti-CD16\u002FIL-15\u002FAnti-CD33) Tri-Specific Killer Engager (TriKE®) for the Treatment of High Risk Myelodysplastic Syndromes (MDS) and Refractory\u002FRelapsed Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* Diagnosis of a high risk myelodysplastic syndromes (MDS), treatment related MDS, OR relapsed\u002Frefractory acute myelogenous leukemia (AML).\n* Absolute lymphocyte count (ALC) ≥ 200 cells\u002FµL OR absolute circulating CD56+\u002FCD3- NK cell count \\>25 cells\u002FµL within the 14 days prior to Cycle 1 Day 1.\n* Peripheral blasts ≤20,000 at the time of treatment start. Hydroxyurea may be used up to Day 1 of the 1st cycle to achieve this threshold and continued for the 1st two weeks of Cycle 1 to maintain it.\n* Karnofsky performance status ≥ 70%\n* Adequate organ function within 14 days (30 days for cardiac) of Cycle 1 Day 1\n* Sexually active persons of childbearing potential or persons with partners of childbearing potential must agree to use a highly effective form of contraception during study treatment and for at least 4 months after the last dose of GTB-3650. Non-childbearing is defined as \\>1 year postmenopausal or surgically sterilized.\n\n-For the Dose Finding Component Only: Must agree to stay within a 60- minute drive of the Study Center through the Cycle 1 Day 29 visit (end of the Dose Limiting Toxicity period).\n\n* Provides voluntary written consent prior to the performance of any research related activity.\n* Pulmonary: room air 0 2 saturation at ≥ 95%\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding. The effect of GTB-3650 TriKE on the fetus is unknown. Persons of childbearing potential must have a negative serum or urine test within 7 days prior to Cycle 1 Day 1 to rule out pregnancy.\n* A candidate for hematopoietic stem cell transplant (HSCT) or newly relapsed after HSCT (e.g. no post-HSCT therapy given).\n* Bi-phenotypic acute leukemia or mixed lineage leukemia.\n* Acute promyelocytic leukemia (APL).\n* No anticancer therapy within 14 days of Cycle 1 Day 1; any AEs from therapy given prior must have resolved to Grade 1 or baseline\n* New or progressive pulmonary infiltrates on screening chest x-ray or chest CT scan unless cleared for study by Pulmonary. Infiltrates attributed to infection must be stable\u002Fimproving with associated clinical improvement after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections).\n* Active systemic infection requiring parenteral antibiotic therapy. Any prior systemic infections must have resolved following optimal therapy.\n* Known history of HIV.\n* Active Hepatitis B or Hepatitis C (virus detectable by PCR) - chronic asymptomatic viral hepatitis is allowed.\n* Positive test results from chronic hepatitis B infection (defined as positive HBsAg serology) and\u002For positive test results for hepatitis C (HCV antibody serology test).\n* Prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer currently in complete remission, or any other cancer from which the patient has been disease-free for 1 year\n* Active central nervous system (CNS) malignancy or symptoms of CNS spread or administration of IT chemotherapy within 14 days prior to Day 1.\n* Extramedullary disease causing symptoms and\u002For involving the CNS or spinal canal - asymptomatic extramedullary disease outside the CNS and spinal canal is eligible provided the marrow has measurable disease.\n* Known autoimmune disease requiring active treatment with steroids or other immunosuppressive medications within 14 days before Cycle 1 Day. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.\n* Persons with a condition requiring systemic treatment with steroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days before Cycle 1 Day 1.\n* The potential risk of QT\u002FQTc prolongation is unknown in humans receiving\n\nTriKE therefore either of the following is an exclusion criteria:\n\n* QTc interval \\> 480 msec at screening\n* A family history of long QT syndrome\n* Psychiatric illness\u002Fsocial situations that, in the judgement of the enrolling Investigator, would limit compliance with study requirements.\n* Other illness or a medical issue that, in the judgement of the enrolling Investigator, would exclude the patient from participating in this study.",{"count":119,"type":21},45,[76],"This is a Phase I dose finding study of GTB-3650 (anti-CD16\u002FIL-15\u002Fanti-CD33) Tri-Specific Killer Engager (TriKE®) for the treatment of select CD33-expressing refractory\u002Frelapsed myeloid malignancies in adults ≥ 18 years of age who are not a candidate for potentially curative therapy, including hematopoietic stem cell transplantation, and are refractory to, intolerant of, or ineligible for therapy options that are known to provide clinical benefit. The hypothesis is GTB-3650 TriKE will induce natural killer (NK) cell function by targeting malignant cells, as well as, CD33+ myeloid derived suppressor cells (MDSC) which contribute to a tumor induced immunosuppression. Because CD16 is the most potent activating receptor on NK cells, this single agent may induce a targeted antiCD33+ tumor response",[123,79,124],"Myeloid Malignancy","Myelodysplastic Syndromes","2026-07-13",{"date":127,"type":33},"2026-07-14",{"date":129,"type":33},"2024-11-19",{"date":131,"type":21},"2027-10-30",{"name":39,"class":40},{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":12,"sex":140,"minAge":18,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":41},"100598379","untold-ovarian-cancer-unmet-needs-survey-100598379","NCT07070726","UNTOLD Ovarian Cancer Unmet Needs Survey","UNderstanding The Experience of Ovarian Cancer Life After Diagnosis (UNTOLD) Study","Inclusion Criteria:\n\n* Ability to read and write in English\n* Diagnosed with ovarian cancer (ovarian, primary peritoneal, fallopian tube)\n\nExclusion Criteria:\n\n\\-","FEMALE",{"count":142,"type":21},2000,"OBSERVATIONAL","The goal of this study is to comprehensively measure ongoing concerns and unmet needs of individuals living with ovarian cancer. To accomplish this, the UNderstanding The experience of Ovarian cancer - Life after Diagnosis (UNTOLD) study will be conducted using a mixed-methods approach. Ovarian cancer survivors will be enrolled to participate in UNTOLD to complete a one-time survey regarding their experiences. Up to 40 survivors will be subsequently identified to complete a follow-up interview. To ensure these sample sizes, along with a representative sample, a combined recruitment strategy will be employed using the California Cancer Registry (population-based) and recruitment through ovarian cancer advocacy groups.",[146],"Ovarian Cancer",[148,149,150],"ovarian cancer","quality of life","cancer survivorship","2026-07-06",{"date":153,"type":33},"2026-07-08",{"date":155,"type":33},"2025-07-10",{"date":157,"type":21},"2029-01-01",{"name":39,"class":40},{"id":160,"slug":161,"hasResults":12,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":49,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":41},"100557953","american-indian-smokefree-native-rct-100557953","NCT06544811","American Indian Smokefree Native RCT","Randomized Clinical Trial of A Culturally Aligned Digital Smoking Cessation Resource for American Indian Persons","Inclusion Criteria:\n\n* AI race based on self-report;\n* ≥ 18 years of age via photo ID confirmation;\n* Average smoked cigarettes per day, ≥ 3 in the past 30 days;\n* considering or willing to make a quit attempt;\n* self-report having daily access to their own iPhone\u002FAndroid smartphone or tablet that allows for messaging use;\n* able to read and speak English.\n\nExclusion Criteria:\n\n* None",{"count":167,"type":21},416,[54],"The aim of this clinical trial is to test the efficacy of a culturally aligned digital smoking cessation resource for American Indian persons who smoke, via a remotely conducted randomized controlled trial.",[57],{"date":153,"type":33},{"date":173,"type":33},"2025-04-14",{"date":175,"type":21},"2029-10-01",{"name":39,"class":40},{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":187,"conditions":188,"keywords":191,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":41},"100545103","phase-2-mt2022-60-ph-2-study-of-pembro-beam-with-asct-for-relapsed-hodgkin-lymphoma-100545103","NCT06377540","MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma","MT2022-60: A Phase II Study of Pembrolizumab+ BEAM Conditioning Regimen Before Autologous Stem Cell Transplant (ASCT) Followed by Pembrolizumab Maintenance in Patients of Relapsed or Refractory Classic Hodgkin Lymphoma","Inclusion Criteria:\n\n* Eligible for autologous stem cell transplant (ASCT) with BEAM conditioning regimen\n* KPS greater than 70 or ECOG ≤ 1\n* Adequate organ function and blood counts within 14 days of study registration\n* Participants who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.\n* Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.\n* HIV-infected participants must have well-controlled HIV on ART\n\nExclusion Criteria:\n\n* Patients with prior history of any grade 2 or higher autoimmune reaction to PD-1 inhibitors, necessitating permanent discontinuation of the PD-1 inhibitor or necessitating systemic immunosuppressants.\n* Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.\n* Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n* Has received any chemotherapy within 3 weeks prior to the first dose of study intervention\n* Has known active CNS disease.\n* History of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents. Exceptions: Participants with vitiligo, resolved childhood asthma or atopy, hypothyroidism, or Sjogren's syndrome, as well as participants requiring only intranasal steroids, intermittent use of bronchodilators, local steroid injections, or physiologic replacement doses of prednisone (≤ 10 mg\u002Fd) may enroll.\n* Has had an allogenic tissue\u002Fsolid organ transplant.\n* Pregnant or breastfeeding as agents used in this study are Pregnancy Category D (positive evidence of risk). Females of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days of study registration",{"count":185,"type":21},28,[24],"This is a Phase 2 single arm study to evaluate efficacy and safety of Pembrolizumab before with BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab Q3week starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant.",[189,190],"Autologous Stem Cell Transplant","Classic Hodgkin Lymphoma",[192,193,194],"BEAM","cHL","ASCT","2026-07-02",{"date":151,"type":33},{"date":198,"type":33},"2024-12-04",{"date":200,"type":21},"2027-09-01",{"name":39,"class":40},{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":22,"phases":212,"briefSummary":213,"conditions":214,"keywords":230,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":242,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":41},"100501157","phase-2-allo-hsct-using-ric-and-ptcy-for-hematological-diseases-100501157","NCT05805605","Allo HSCT Using RIC and PTCy for Hematological Diseases","Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases","Inclusion Criteria:\n\n* Age 0 to 75 years of age with Karnofsky score ≥ 70% (≥ 16 years) or Lansky score ≥ 50 (\\\u003C 16 years).\n* 5\u002F6 or 6\u002F6 related donor, OR a 7-8\u002F8 HLA-A, B, C, DRB1 allele match, OR a haplotype (at least 5\u002F10) matched related donor. Donors will be requested to provide PBSCs although bone marrow is acceptable according to donor preference.\n\nEligible Diseases Acute Leukemias: Must be in remission by morphology (≤5% blasts) AND without evidence of MRD by flow cytometry, FISH, or conventional cytogenetics. PCR based MRD detection is not an exclusion to proceed.\n\nAcute Myeloid Leukemia (AML) and related precursor neoplasms:\n\n2nd or greater complete remission (CR); first complete remission (CR1) in patients \\> 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk.\n\nFavorable risk AML is defined as having one of the following:\n\n* t(8,21) without cKIT mutation\n* inv(16) or t(16;16) without cKIT mutation\n* Normal karyotype with mutated NPM1 and wild type FLT-ITD (unless persistently NPM1 positive by PCR following two cycles of chemotherapy)\n* Normal karyotype with double mutated CEBPA\n* Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation\n\nAcute lymphoblastic Leukemia (ALL) \u002Flymphoma:\n\nCR2 or greater, CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL.\n\nHigh risk ALL is defined as having one of the following:\n\n* Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1\n* 30 years of age or older at diagnosis\n* White blood cell counts of greater than 30,000\u002FmcL (B-ALL) or greater than 100,000\u002FmcL (T-ALL) at diagnosis\n* CNS leukemia involvement during the course of disease\n* Slow cytologic response (\\>10% lymphoblasts in bone marrow on Day 14 of induction therapy)\n* Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy.\n\nVery high risk pediatric patients with ALL:\n\npatients \\\u003C21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieved a complete remission.\n\nBiphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias in first or subsequent CR.\n\nChronic Myelogenous Leukemia in chronic or accelerated phase, or CML blast crisis in morphological remission (\\\u003C5% blasts) and with negative MRD by flow cytometry (a positive PCR for BCRABL is acceptable for BMT): Chronic phase patients must have failed at least two different TKIs, been intolerant to all available TKIs or have T315I mutation. Patients with CML blast crisis in CR are only eligible if there is an feasible TKI maintenance plan following BMT.\n\nPlasma Cell Leukemia after initial therapy, who achieved at least a partial remission; or relapsed and achieved subsequent remission (CR\u002FPR) Myelodysplastic Syndrome: IPSS INT-2 or High Risk; R-IPSS High or Very High; WHO classification: RAEB-1, RAEB-2; Severe Cytopenias: ANC \\\u003C 0.8, Anemia or thrombocytopenia requiring transfusion; Poor or very poor risk cytogenetics based on IPSS or R-IPSS definitions; therapy-related MDS. Blasts must be \\\u003C 5% by bone marrow aspirate morphology. If ≥5% blasts, patient requires chemotherapy for cytoreduction to \\\u003C5% blasts prior to transplantation Leukemia or MDS in aplasia. These patients may be taken to transplant if after induction therapy they remain with aplastic bone marrow and no morphological or flow-cytometry evidence of disease ≥ 28 days post-therapy. These high risk patients will be analyzed separately.\n\nBurkitt's Lymphoma in CR2 or subsequent CR. Relapsed T-Cell Lymphoma that is chemotherapy sensitive in CR\u002FPR that has failed or ineligible for an autologous transplantNatural Killer Cell Malignancies. Relapsed Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma which have progressed within 12 months of achieving a partial or complete remission. Patients who had remissions lasting \\> 12 months, are eligible after at least two prior therapies. Patients with bulky disease should be considered for de-bulking chemotherapy before transplant. Patients with refractory disease may be eligible, unless bulky disease and an estimated tumor doubling time of less than one month.\n\nLymphoplasmacytic Lymphoma, Mantle-Cell Lymphomais eligible after initial therapy if chemotherapy sensitive.\n\nLarge Cell and other high risk NHL \\> CR2\u002F\\> PR2: Patients in CR2\u002FPR2 with initial short remission (\\\u003C6 months) are eligible.\n\nRelapsed Multiple Myeloma: that is chemotherapy sensitive and has failed or ineligible for an autologous transplant.\n\nMyeloproliferative Neoplasms\u002FMyelofibrosis - with transfusion dependence or expected survival under 5 years by DIPSS, DIPSS-plus, or MPSS70 calculator.\n\nAcquired Bone Marrow Failure Syndromes except for Fanconi anemia Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.\n\nAdditional Criteria for Bulky Disease (lymphomas) if stable disease is best response, the largest residual nodal mass must \\\u003C 5 cm (approximately) If response to previous therapy, the largest residual mass must represent a 50% reduction and be \\\u003C 7.5 cm (approximately)\n\nOrgan Function Criteria\n\nAdequate organ function is defined as:\n\nLiver: Transaminases ≤ 5 x upper limit of normal (ULN) and total bilirubin ≤ 2.5 mg\u002FdL except for patients with Gilbert's syndrome or hemolysis.\n\nRenal: A normal creatinine (adults) or creatinine clearance ≥ 40 mL\u002Fmin (pediatrics). Adults with a creatinine \\> 1.2 mg\u002Fdl or a history of renal dysfunction must have estimated GFR ≥ 40 ml\u002Fmin\u002F1.73m2.\n\nCardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \\> 40%. For children that are not able to cooperate with MUGA and echocardiography, such should be clearly stated in the physician's note.\n\nPulmonary: DLCO, FEV1, FVC ≥ 40% predicted, and absence of O2 requirements. For children that are not able to cooperate with PFTs, a pulse oximetry with exercise should be attempted. If neither test can be obtained it should be clearly stated in the physician's note.\n\nIf recent confirmed mold infection (e.g. aspergillus) must have minimum of 30 days of therapy and responsive disease and be cleared by Infectious Disease HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation Sexually active females of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control during study treatment Voluntary written consent (adult or parent\u002Fguardian with presentation of the minor information sheet, if appropriate)\n\nRelated donors will be evaluated and collected according to UMN BMT program standard processes. Unrelated donors will be identified and collected through the National Marrow and Donor Program (NMDP) per usual steps.\n\nExclusion Criteria:\n\n* Pregnant or breast feeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.\n* Untreated active infection\n* Active central nervous system malignancy\n* CML in blast crisis\n* Intermediate or high grade NHL, mantle cell NHL, and Hodgkin disease that is progressive on salvage therapy. Stable disease is acceptable to move forward provided it is non-bulky.\n* Less than 3 months since prior myeloablative transplant\n* Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.","75 Years",{"count":211,"type":21},56,[24],"This is a Phase II study following subjects proceeding with our Institutional non-myeloablative cyclophosphamide\u002F fludarabine\u002Ftotal body irradiation (TBI) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion using post-transplant cyclophosphamide (PTCy), sirolimus and MMF GVHD prophylaxis.",[215,216,217,218,219,220,221,124,222,223,224,225,226,227,28,27,228,229],"Acute Myelogenous Leukemia","Acute Lymphocytic Leukemia","Biphenotypic Acute Leukemia","Undifferentiated Leukemia","Prolymphocytic Leukemia","Chronic Myelogenous Leukemia","Plasma Cell Leukemia","Leukemia, Myeloid","Myelodysplastic Syndrome With Excess Blasts-1","Burkitt Lymphoma","Relapsed T-Cell Lymphoma","Relapsed Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Myeloproliferative Neoplasm","Myelofibrosis",[231,232,233,234,235,236,237,238,239,240,241,17],"MDS","CLL","SLL","AML","CML","PFS","TRM","GVHD","MMF","TBI","PTCy",{"date":151,"type":33},{"date":244,"type":33},"2023-05-01",{"date":246,"type":21},"2028-10-22",{"name":39,"class":40},{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":22,"phases":257,"briefSummary":258,"conditions":259,"keywords":263,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":41},"100183644","second-or-greater-allogeneic-hematopoietic-stem-cell-transplant-using-reduced-intensity-conditioning-ric-100183644","NCT01666080","Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)","Inclusion Criteria:\n\n* Diagnosis of any disease for which a second or greater hematopoietic stem cell transplant is needed due to insufficient donor chimerism following hematopoietic recovery after previous HSCT. Determination of \"insufficiency of donor chimerism\" will be made by the treating transplant physician. Occasionally donor derived engraftment may be present, but sustained aplasia or failed recovery of sufficient hematopoiesis requires administration of a second graft. This intervention may be used for both situations.\n* Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program\n\n  * Transplantation using sufficiently matched related donors (such as matched siblings) or unrelated donors will be considered. Both granulocyte-colony stimulating factor (GCSF) stimulated peripheral blood grafts and bone marrow grafts will be considered, although bone marrow will be the priority.\n  * Cord blood grafts, both related and unrelated, are also eligible. As this protocol will use a reduced intensity regimen, this protocol will use the current recommendations of the University of Minnesota for choosing cord blood grafts. If a single cord blood unit cell dose is insufficient, double cord transplantation should be considered if sufficiently matched cord blood units are available. The priority of choosing cord blood donors is based on the current institutional recommendations.\n  * Exclusion of Metabolic Disorder or other Inherited Disorder Carrier Status from related donor and unrelated cord blood grafts as appropriate for primary disease.\n\nAt the discretion of the treating transplant physician, an allograft from the previous donor may be used, if available.\n\n* Age, Performance Status, Consent\n\n  * Age: 0 to 55 years\n  * Consent: voluntary written consent (adult or parental\u002Fguardian)\n\nExclusion Criteria:\n\n* Previous irradiation that precludes the safe administration of an additional dose of 200 cGy of total body irradiation (TBI). Radiation Oncology will evaluate all patients who have had previous radiation therapy or TBI for approval to receive an additional 200 cGy of TBI\n* Pregnant or breastfeeding\n* Active, uncontrolled infection - infection that is stable or improving after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections) will be permitted\n* HIV positive\n* While it would be advantageous to begin therapy on this second transplant regimen \\> 6 months following a prior myeloablative regimen or \\>2 months after a reduced intensity regimen, it is recognized that there are circumstances where this may not be practical.","55 Years",{"count":256,"type":21},30,[54],"This is a treatment guideline for a second or greater allogeneic hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) in patients with non-malignant or malignant diseases. This regimen, consisting of busulfan, fludarabine, and low dose total body irradiation (TBI), is designed to promote engraftment in patients who failed to achieve an acceptable level of donor-derived engraftment following a previous allogeneic HCT.",[260,261,262],"Hematologic Disorders","Hemoglobinopathies","Immunodeficiencies",[264,265,266,267],"second stem cell transplant","donor hematopoietic engraftment","hematopoietic stem cell transplantation","inherited metabolic disorder",{"date":151,"type":33},{"date":270,"type":33},"2012-08",{"date":272,"type":21},"2028-06",{"name":39,"class":40},{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":281,"enrollmentInfo":282,"targetDuration":4,"studyType":22,"phases":284,"briefSummary":285,"conditions":286,"keywords":307,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":41},"100309946","phase-2-myeloablative-allo-hsct-with-related-or-unrelated-donor-for-heme-disorders-100309946","NCT03314974","Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders","Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Unrelated Donor for the Treatment of Hematological Diseases","-Inclusion Criteria:\n\n* Age: ≤ 60 years of age\n* Performance Status: Karnofsky ≥ 70%, Lansky play score ≥ 70\n* Consent: Voluntary written consent (adult or legally authorized representative; or parental\u002Fguardian)\n* Adequate Organ Function:\n\n  * Renal: Creatinine \\\u003C2x upper limit of normal. Patients above this limit must have creatinine clearance ≥ 40 ml\u002Fmin\u002F1.73m2 as determined by an age-appropriate method, such as cystatin C GFR.\n  * Hepatic: Bilirubin, AST, alkaline phosphatase \\\u003C4 times the upper limit of institutional normal\n  * Pulmonary: Diffusion capacity of oxygen, corrected for hemoglobin, \\> 50% of predicted. For pediatric patients not able to undergo PFTs or diffusion testing: O2 sat of \\>95% on room air\n  * Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \\> 45%. For children not able to cooperate with MUGA or echocardiography, such should be clearly stated in the physician's documentation\n  * HIV Status: HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation\n\nOther Inclusion Criteria:\n\n* 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.\n* Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program\n* Eligible Diseases and Status: Patients are eligible unless their treatment is to be guided by a higher priority protocol.\n* Acute Leukemias: Must be in remission by morphology (≤5% blasts). Also a small percentage of blasts that is equivocal between marrow regeneration vs. early relapse are acceptable provided there are no associated cytogenetic markers consistent with relapse.\n* Acute Myeloid Leukemia (AML) and related precursor neoplasms: 2nd or greater complete remission (CR); first complete remission (CR1) in patients \\> 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk.\n* Favorable risk AML is defined as having one of the following:\n\n  * t(8,21) without cKIT mutation\n  * inv(16) or t(16;16) without cKIT mutation\n  * Normal karyotype with mutated NPM1 and wild type FLT-ITD\n  * Normal karyotype with double mutated CEBPA\n  * Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation\n* Very high risk pediatric patients with AML: Patients \\\u003C21 years, however, are eligible with (M2 marrow) with \\\u003C 25% blasts in marrow after having failed one or more cycles of chemotherapy.\n* Acute lymphoblastic leukemia (ALL)\u002Flymphoma: second or greater CR; CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL.\n* High risk ALL is defined as having one of the following:\n\n  * Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1\n  * 30 years of age or older at diagnosis\n  * White blood cell counts of greater than 30,000\u002FmcL (B-ALL) or greater than 100,000\u002FmcL (T-ALL) at diagnosis\n  * CNS leukemia involvement during the course of disease\n  * Slow cytologic response (\\>10% lymphoblasts in bone marrow on Day 14 of induction therapy)\n  * Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy\n* Very high risk pediatric patients with ALL: patients \\\u003C21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieve a complete remission.\n* Chronic Myelogenous Leukemia excluding refractory blast crisis: To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to one or more tyrosine kinase inhibitors.\n* Plasma Cell Leukemia after initial therapy, in patients who have achieved at least a partial remission\n* Myeloproliferative Neoplasms\u002FMyelofibrosis, either primary as a result of polycythemia vera or essential thrombocythemia, with disease risk of intermediate or high-risk according to DIPSS criteria. Blasts must be \\\u003C10% by bone marrow aspirate morphology.\n* Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features. Blasts must be \\\u003C 10% by a representative bone marrow aspirate morphology.\n* Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma are eligible if there was disease progression\u002Frelapse within 12 of achieving a partial or complete remission. Patients who had remissions lasting \\> 12 months, are eligible after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for debulking chemotherapy before transplant.\n* Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia are eligible after initial therapy in CR1+ or PR1+.\n* Diffuse large Cell NHL \\> CR\u002F\\> PR: Patients in CR\u002FPR with initial short remission (\\\u003C6 months) are eligible, or those who have failed\u002For are not eligible for autologous transplant.\n* Lymphoblastic Lymphoma, Burkitt's Lymphoma, and other high-grade NHL after initial therapy if stage III\u002FIV in CR1\u002FPR1 or after progression if stage I\u002FII \\\u003C 1 year.\n* Multiple Myeloma beyond PR2: Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or β-2 microglobulin \\> 3 mg\u002FL, may be considered for this protocol after initial therapy.\n* Juvenile myelomonocytic leukemia\n* Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias in first or subsequent CR.\n* MRD positive leukemia (AML, ALL or accelerated\u002Fblast phase CML). Selected patients in morphologic CR, but with positive immunophenotypic (flow cytometry) or molecular evidence of MRD may be eligible if recent chemotherapy has not resulted in MRD negative status.\n* Natural Killer Cell Malignancies\n* Acquired Bone Marrow Failure Syndromes except for Fanconi Anemia or Dyskeratosis Congenita\n* Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.\n\nExclusion Criteria:\n\n* Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after \\> 2 salvage regimens)\n* CML in blast crisis\n* Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy.\n* Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.\n* Active central nervous system malignancy\n* if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If \\>18 years old prior myeloablative allotransplant or autologous transplant\n* Active HIV infection or known HIV positive serology\n* active uncontrolled infection\n* Pregnant or breastfeeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.","60 Years",{"count":283,"type":21},300,[24],"This is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a myeloablative preparative regimen (of either total body irradiation (TBI); or, fludarabine\u002Fbusulfan for patients unable to receive further radiation). followed by a post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).",[287,79,288,289,220,221,290,229,291,292,293,294,227,295,27,296,297,219,298,299,224,300,301,302,303,304,305,306],"Acute Leukemia","Acute Lymphoblastic Leukemia","Lymphoma","Myeloproliferative Neoplasms","Myelodysplasia","Refractory Anemia","High Risk Anemia","Chronic Lymphocytic Leukemia","Marginal Zone B-Cell Lymphoma","Lymphoplasmacytic Lymphoma","Mantle-Cell Lymphoma","Diffuse Large Cell Non Hodgkins Lymphoma","Lymphoblastic Lymphoma","High Grade Non-Hodgkin's Lymphoma, Adult","Multiple Myeloma","Juvenile Myelomonocytic Leukemia","Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias","MRD Positive Leukemia","Natural Killer Cell Malignancies","Acquired Bone Marrow Failure Syndromes",[234,17,231,308,232,235,233],"NHL","2026-06-23",{"date":311,"type":33},"2026-06-25",{"date":313,"type":33},"2018-03-30",{"date":315,"type":21},"2028-06-10",{"name":39,"class":40},{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":49,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":22,"phases":325,"briefSummary":326,"conditions":327,"keywords":4,"overallStatus":335,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":4},"100642375","gutcheck-optimization-of-a-personalized-mobile-health-app-for-survivors-of-gastrointestinal-cancer-100642375","NCT07661017","GutCheck: Optimization of a Personalized Mobile Health App for Survivors of Gastrointestinal Cancer","Inclusion\n\nSurvivors of GI cancer are eligible if they are:\n\n* ≥18 years old\n* reside in or have received cancer care in Minnesota\n* own a smartphone • consent to install the GutCheck app and discontinue diet tracking in other lifestyle apps (e.g., MyFitness, Fitbit, Noom).\n* are English-speaking\n* have received a GI cancer diagnosis (e.g., esophageal, gastric, colorectal, liver, pancreatic, etc)\n* At least 2 months post-cancer treatment\n\nInclusion criteria for oncology specialists (oncologists, advanced practice providers, nurses, dietitians, and patient navigators) include:\n\n* Have interacted with at least 1 cancer patient or survivor in the past month.\n* Have experience working with electronic health records (EHR).\n\nExclusion\n\n* Currently pregnant (Patient Study ONLY)\n* Pregnancy status may be self-reported by the participant.\n* Individuals who are postmenopausal, surgically sterile, or otherwise unable to become pregnant are not subject to this exclusion.\n* Active cancer or receiving treatment for another cancer.\n* Currently taking or has taken antibiotics in the last 3 months.\n* Diagnosis of inflammatory bowel disease (e.g., Crohn's Disease, ulcerative colitis), and\u002For celiac disease.\n* Involuntary weight loss of 10% or more of usual body weight within 6 months, or involuntary loss of 5% or more of usual body weight in 1 month.\n\nOncology specialists' exclusion criteria include:\n\n* Unable to participate in an interview",{"count":324,"type":21},200,[54],"There are two components to the study: a patient and a clinician study. The clinician study will include one-hour semi-structured interviews with oncology specialists to identify facilitators and barriers to integrating digital diet interventions into the clinical workflow, and to understand their needs and preferences for digital diet interventions. The patient study aims to investigate initial feasibility, efficacy and acceptability of the GutCheck app and intervention. It will last 9 weeks and involves 2 study visits and 2 active phases with a transition week and optional transition visit between phases. During active phases, participants will be asked to use the GutCheck app every day. Prior to the first active phase, participants will go through informed consent and app training. The first active phase will last two weeks and will focus on tracking participants' diet, gastrointestinal (GI) symptoms, and stress. The data collected during the first active phase will be used to identify any potential trigger foods that may contribute to GI symptoms, but only if the participant reports experiencing GI symptoms. Between active phases, participants will have one Transition Week, where results from the first phase are given to the participants with the option to attend a Transition Week Visit. The second active phase will last four weeks and will involve the message intervention. A single-blind, micro-randomized trial design will be used to repeatedly randomize participants to different intervention combinations, determining both the timing and frequency of intervention message delivery throughout the day. Lastly, there will be an exit visit and interview within a week from the intervention to collect post-intervention measures and ask about the participant's experience with the GutCheck app.",[328,329,330,331,332,333,334],"Gastrointestinal","Mobile Health","Gastrointestinal Symptoms","Gut Health","Gastrointestinal Cancer","Survivorship","GI Cancer","NOT_YET_RECRUITING","2026-06-16",{"date":338,"type":33},"2026-06-22",{"date":340,"type":21},"2026-12",{"date":342,"type":21},"2030-06",{"name":39,"class":40},{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":17,"minAge":350,"maxAge":209,"enrollmentInfo":351,"targetDuration":4,"studyType":22,"phases":353,"briefSummary":354,"conditions":355,"keywords":360,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":41},"100547786","phase-2-mt2023-20-hematopoietic-cell-transplant-with-reduced-intensity-conditioning-and-post-transplant-cyclophosphamide-for-severe-aplastic-anemia-and-other-forms-of-acquired-bone-marrow-failure-100547786","NCT06412497","MT2023-20: Hematopoietic Cell Transplant With Reduced Intensity Conditioning and Post-transplant Cyclophosphamide for Severe Aplastic Anemia and Other Forms of Acquired Bone Marrow Failure.","Inclusion Criteria:\n\n* Idiopathic Severe Aplastic Anemia (SAA), characterized by one of the following:\n\n  1. Refractory cytopenia(s), with 1+ of the following:\n\n     1. Platelets \\\u003C20,000\u002FuL or transfusion dependent\n     2. Absolute neutrophil count \\\u003C500\u002FuL without hematopoietic growth factor support\n     3. Absolute reticulocyte count \\\u003C60,000\u002FuL AND bone marrow cellularity \\\u003C50% (with \\\u003C 30% residual hematopoietic cells)\n  2. Early myelodysplastic features (bone marrow (BM) blasts \\\u003C5%), without history of MDS\u002FAML pre-treatment.\n  3. Idiopathic SAA with post-HCT graft failure (blood\u002Fmarrow donor chimerism \\\u003C5%) requiring a 2nd allogeneic HCT\n* Paroxysmal Nocturnal Hemoglobinuria (PNH), including AA-PNH overlap syndrome, acquired pure red cell aplasia (aPRCA), or acquired amegakaryocytic thrombocytopenia (aAT), characterized by one of the following:\n\n  1. Refractory cytopenia(s), with 1+ of the following:\n\n     1. Platelets \\\u003C20,000\u002FuL or transfusion dependent\n     2. Absolute neutrophil count \\\u003C500\u002FuL without hematopoietic growth factor support\n     3. Absolute reticulocyte count \\\u003C60,000\u002FuL or red cell transfusion dependent AND Bone marrow evidence of 1 to 3-lineage aplasia OR peripheral blood PNH clone \\>\u002F= 10%\n  2. Early myelodysplastic features (bone marrow (BM) blasts \\\u003C5%) without history of MDS\u002FAML pre-treatment.\n  3. Idiopathic PNH, aPRCA, or aAT with post-HCT graft failure (blood\u002Fmarrow donor chimerism \\\u003C5%) requiring a 2nd allogeneic HCT\n* Adequate organ function within 30 days of conditioning regimen\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding or intending to become pregnant during the study. Persons of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days of the start of treatment\n* Uncontrolled infection\n* Evidence of moderate or severe portal fibrosis or cirrhosis on biopsy\n* Known allergy to any of the study components\n* Prior radiation therapy deemed excessive by radiation therapist for proposed low dose TBI exposure on this protocol\n* Diagnosis of an inherited bone marrow failure disorder such as Fanconi anemia, Telomere biology disorder, or Schwachman-Diamond syndrome, unless reviewed by the principal investigator and deemed appropriate for this approach (e.g. GATA2 deficiency)\n* Advanced myelodysplastic syndrome (MDS; BM blasts \\>5%) or acute myeloid leukemia\n* Psychiatric illness\u002Fsocial situations that, in the judgement of the enrolling Investigator, would limit compliance with study requirements\n* Other illness or a medical issue that, in the judgement of the enrolling Investigator, would exclude the patient from participating in this study","0 Years",{"count":352,"type":21},60,[24],"A phase II trial of a reduced intensity conditioned (RIC) allogeneic hematopoietic cell transplant (HCT) with post-transplant cyclophosphamide (PTCy) for idiopathic severe aplastic anemia (SAA), paroxysmal nocturnal hemoglobinuria (PNH), acquired pure red cell aplasia (aPRCA), or acquired amegakaryocytic thrombocytopenia (aAT) utilizing population pharmacokinetic (popPK)-guided individual dosing of pre-transplant conditioning and differential dosing of low dose total body irradiation based on age, presence of myelodysplasia and\u002For clonal hematopoiesis.",[356,357,358,359],"Severe Aplastic Anemia","Acquired Amegakaryocytic Thrombocytopenia","Acquired Pure Red Cell Aplasia","Paroxysmal Nocturnal Hemoglobinuria",[361,362,363,241,364,365],"HCT","RIC","SAA","aAT","aPRCA","2026-06-02",{"date":368,"type":33},"2026-06-03",{"date":370,"type":33},"2024-06-05",{"date":372,"type":21},"2036-05-01",{"name":39,"class":40},{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":49,"sex":17,"minAge":4,"maxAge":254,"enrollmentInfo":381,"targetDuration":4,"studyType":22,"phases":383,"briefSummary":384,"conditions":385,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":392,"leadSponsor":394,"locationsCount":41},"100583131","phase-2-allo-hsct-for-high-risk-hemoglobinopathies-100583131","NCT06872333","Allo HSCT for High Risk Hemoglobinopathies","Allogeneic Hematopoietic Stem Cell Transplant for Patients With High Risk Hemoglobinopathies and Other Red Cell Transfusion Dependent Disorders","Inclusion Criteria:\n\n* Sickle Cell Disease (SCD)\n* SCD Patients with a fully matched sibling donor (MSD) irrespective of the frequency or severity of symptoms MSD transplant can be considered. Parents\u002Fpatient must be counseled as to the risks and benefits and provide their voluntary informed consent\n* Transfusion Dependent Alpha- or Beta- Thalassemia\n* Diamond Blackfan Anemia\n* Other Non-Malignant Hematologic Disorders\n* Karnofsky ≥ 60%, Lansky play score ≥ 60. Patients with lower performance score can be considered based on study team's evaluation.\n* Sexually active persons of childbearing potential or persons with partners of childbearing potential must agree to use a highly effective form of contraception during study treatment and for at least 4 months after the transplant.\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding or intending to become pregnant during the study. Persons of childbearing potential must have a negative pregnancy test (serum or urine) within 30 days of the start of treatment\n* HIV infection with a detectable viral load. All HIV+ patients must be evaluated by infectious disease (ID) and an HIV management plan established prior to transplantation.\n* Active, uncontrolled infection - infection that is stable or improving after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections) will be permitted\n* Known allergy to any of the study components\n* Psychiatric illness\u002Fsocial situations that, in the judgement of the enrolling Investigator, would limit compliance with study requirements\n* Other illness or a medical issue that, in the judgement of the enrolling Investigator, would exclude the patient from participating in this study",{"count":382,"type":21},62,[24],"A single center, open label, interventional, phase II trial for donor transplant for high risk hemoglobinopathies and other red cell transfusion dependent disorders utilizing allogeneic hematopoietic stem cell transplantation (HSCT) regimens.",[386,387,261],"Graft Failure","Sickle Cell Disease","2026-06-01",{"date":390,"type":33},"2026-06-04",{"date":129,"type":33},{"date":393,"type":21},"2032-06-01",{"name":39,"class":40},{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":22,"phases":404,"briefSummary":405,"conditions":406,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":41},"100639057","phase-1-adapt-nk-for-high-risk-myeloid-diseases-as-bridge-to-allo-hsct-100639057","NCT07591649","Adapt NK for High Risk Myeloid Diseases as Bridge to Allo HSCT","Safety and Efficacy of Expanded KIR-HLA Mismatched Natural Killer Cell Immunotherapy (AdaptNK) for High-Risk Myeloid Diseases as Bridge to Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* 18-74 years with Karnofsky score ≥ 70%\n* 75 years and older: KPS ≥ 70%, HCT-CI \\\u003C 5 (excluding history of solid tumor), AND not frail by Fried frailty criteria (see Appendix III)\n* HLA type C1\u002FC1 or C2\u002FC2\n\nNote: For easy determination, the definition of HLA-C ligand group assigments is included below:\n\nHLA-C1 group alleles are defined as HLA-C01, C03, C07, C08, C12, C14, C16 HLA-C2 group alleles are defined as HLA-C02, C04, C05, C06, C15, C17, C18\n\n* adequate liver, renal, pulmonary and cardiac function\n* ability to be off glucocorticoids and other immunosuppressive medications indicated for acute or chronic GVHD for at least 28 days prior to the AdaptNK cell infusion\n* There must be sufficient time between the most recent therapy and the screening bone marrow as delineated below:\n* anti-leukemic systemic cytotoxic chemotherapy - 2 weeks\n* Targeted anti-leukemic agents (FLT-3, IDH, menin inhibitors) - 3 half-lives of the medication\n* Radiotherapy - 1 week\n* donor lymphocyte infusions - 6 weeks\n* hematopoietic growth factors (filgrastim, TPO agonists, EPO) - 1 week\n* biologic therapy (monoclonal antibodies, T-cell engagers) - 2 weeks\n* Immune effector cellular therapy - 4 weeks\n* Intrathecal chemotherapy for treatment of active CNS leukemia - there must be at least two CSF samples negative for leukemia separated by one week before enrollment.\n* WBC shall be \\\u003C 25,000 before infusion. Hydroxyurea is permitted until day -3 to control excess blast proliferation. No other systemic treatment is allowed after the screening bone marrow is performed for inclusion in protocol\n* All prior treatment related toxicities should have resolved to ≤ grade 1 prior to study enrollment\n* agrees to use of adequate contraception from study enrollment to 4 months after cell infusion\n* voluntary written consent\n\nExclusion Criteria:\n\n* Myeloid neoplasms with known or strongly suspected germline background, except DDX41, TP53, or RUNX1.\n* Acute promyelocytic leukemia (APL)\n* myocardial infarction (MI) within previous 6 months of study enrollment\n* pregnant or breastfeeding\n* Active CNS involvement with AML\n* new or progressive pulmonary infiltrates\n* active autoimmune disease requiring immunosuppressive therapy\n* Preexisting inflammatory disease requiring immunosuppressive therapy\n* history of severe asthma and currently on chronic systemic medications\n* HIV-1\u002F2 positivity or hepatitis C\u002FB\n* active systemic infections requiring anti-infective treatment\n* received any investigational agent within the 14 days before the start of study treatment (1st dose of fludarabine)\n* Patients with second malignancies are excluded if they have required systemic cytotoxic chemotherapy within 1 year or if they are not in remission\n* Exception: patients that are on stable dosing of hormonal therapy (e.g. aromatase inhibitor or antiandrogen therapy) for active breast or prostate cancer for 1 year are eligible.\n* Patients with excised basal cell or squamous cell carcinoma of the skin are eligible.\n* Patients with excised carcinoma in situ of the cervix or breast are eligible.\n* Patients with untreated T1a or T1b prostate cancer are eligible.",{"count":403,"type":21},18,[76,24],"This is a multi-institutional Phase I\u002FII study of an allogeneic KIR-HLA mismatched NK cell infusion (AdaptNK) and a short course of subcutaneous interleukin-2 (IL-2) administered after lymphodepleting chemotherapy \\[cyclophosphamide (CY)\u002Ffludarabine (FLU)\\] in patients with relapsed or refractory acute myelogenous leukemia (AML). AdaptNK is a natural killer (NK) cell product that is enriched for NK cells with an \"adaptive\", or human cytomegalovirus (CMV)-induced, phenotype.",[407,408,215],"Relapsed Adult AML","Refractory AML","2026-05-15",{"date":411,"type":33},"2026-05-19",{"date":413,"type":33},"2026-05-08",{"date":415,"type":21},"2035-03-01",{"name":39,"class":40},{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":423,"targetDuration":425,"studyType":143,"phases":4,"briefSummary":426,"conditions":427,"keywords":431,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":41},"100346360","adrenoleukodystrophy-national-registry-study-100346360","NCT03789721","Adrenoleukodystrophy National Registry Study","Inclusion Criteria\n\n* Age 0 - 100\n* ALD patients or family member meeting any of the following criteria:\n\n  * Any patient diagnosed with ALD (confirmed by positive VLCFA testing and\u002For genetic mutation).\n  * Known or presumed mutation with ALD based on pedigree or confirmed mutation in ABCD1 gene\n* Participants living in the United States and territories\n\nExclusion Criteria\n\n* Patients diagnosed with ALD who lack the capacity to consent\u002Fassent AND do not have a designated legally authorized representative or guardian.\n* Patients who have undergone BMT or other cellular therapy .\n* Patients not fluent in English who are unable to consent in-person at the BMT Journey Clinic.\n* Patients who are illiterate\n* Patient determined by the PI or designee to be unlikely to complete required study components (due to language barriers, compliance issues, etc.)",{"count":424,"type":21},1000,"99 Years","The aim of this registry to understand the natural history and disease progression in ALD and potentially develop bio-markers using the biospecimens collected using this registry.",[428,429,430],"ALD (Adrenoleukodystrophy)","Adrenoleukodystrophy","Cerebral Adrenoleukodystrophy",[432],"Registry, VLCFA, ABCD1, X-chromosome","2026-05-11",{"date":435,"type":33},"2026-05-12",{"date":437,"type":33},"2019-05-01",{"date":439,"type":21},"2030-02",{"name":39,"class":40},{"id":442,"slug":443,"hasResults":12,"nctId":444,"briefTitle":445,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":22,"phases":449,"briefSummary":450,"conditions":451,"keywords":454,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":41},"100167322","infusion-of-cell-populations-from-unlicensed-umbilical-cord-blood-units-100167322","NCT01451502","Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units","Inclusion Criteria:\n\nTo be eligible for an unlicensed umbilical cord blood (UCB) unit, the subject must meet each of the eligibility criteria listed below:\n\n* Subjects with any diagnosis for which there is an institutional review board (IRB) approved treatment protocol that requires UCB as a source of hematopoietic stem cells for lympho-hematopoietic reconstitution after myeloablative or non myeloablative conditioning.\n* Subject (or parent\u002Fguardian) must provide written informed consent for the use of unlicensed UCB units with co-enrollment onto a University of Minnesota IRB-approved clinical trial that details the disease specific treatment plan that prescribes the use of UCB as source of cells\n* Subject has an unlicensed UCB unit that meets required cell dose and HLA matching criteria (as defined in the primary treatment protocol) that is considered negative for tested blood-borne pathogens and also lack an 'equivalent', licensed UCB unit from a University of Minnesota approved Cord Blood Bank\n\nExclusion Criteria:\n\n* Exclusion criteria are specified in the treatment protocol according to indication.",{"count":448,"type":21},250,[54],"For the next 5-10 years or possibly longer, a high proportion of the Cord Blood Banks (CBB) inventory worldwide will be composed of unlicensed umbilical cord blood (UCB) units. While Food and Drug Administration (FDA)-licensed units will be prioritized, it will always be possible that an unlicensed unit will have known attributes, making it a better source of cells for the given indication. Because of the wide variety of current and potential indications as a source of cells for hematopoietic reconstitution or other form of cellular therapy, it is critical that the investigators have access to unlicensed UCB units.",[452,453],"Lymphatic Diseases","Hematopoietic Malignancy",[455],"umbilical cord blood","2026-05-07",{"date":413,"type":33},{"date":459,"type":33},"2011-10-20",{"date":461,"type":21},"2027-02",{"name":39,"class":40},{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":467,"acronym":4,"eligibilityCriteria":468,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":209,"enrollmentInfo":469,"targetDuration":4,"studyType":22,"phases":471,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":41},"100636067","phase-1-first-in-cancer-type-phase-i-study-of-ft536-for-recurrent-who-grade-4-astrocytoma-100636067","NCT07560865","First-in Cancer-Type Phase I Study of FT536 for Recurrent WHO Grade 4 Astrocytoma","Inclusion Criteria:\n\n* Histologically confirmed WHO Grade 4 astrocytoma from archival tissue. IDH mutation status and MGMT promoter methylation status will not limit candidacy but needs to be known.\n* Evidence of first or second cancer recurrence\u002F progression by magnetic resonance imaging (MRI) for which a gross tumor resection (GTR) is feasible as determined by the primary investigator in concordance with the study-affiliated neurosurgeon.\n* Previous completed SOC antitumor treatment including surgery, radiation therapy, and temozolomide +\u002F- Optune\u002F Tumor Treatment Fields (TTF).\n* No concurrent alternative curative therapy, including use of TTF.\n* Able to undergo standard MRI scans with contrast agent throughout the course of the study.\n* ≥ 18 years and ≤ 75 years of age at the time of consent.\n* Karnofsky performance status ≥70.\n* Must be completely off or on a dose of dexamethasone 2mg daily or less with stable neurological function at the time of enrollment.\n* Adequate organ function within 14 days of study treatment start as defined in Section 4.1.9 of the protocol.\n* Participants of childbearing potential (POCBP) or with partners of childbearing potential must use a highly effective form of contraception from the time of the screening visit until at least 3 months after the dose of FT536.\n* Must agree to and sign the consent for the companion Long-Term Follow-Up study (CPRC# 2021LS077).\n* Voluntary written consent prior to the performance of any research related procedures.\n* Agree to stay in the Twin Cities metropolitan area (i.e. within a 45-minute drive of the UMN) from the time of biopsy through hospital discharge following completion of the planned craniotomy.\n\nExclusion Criteria:\n\n* Clinically significant increased intracranial pressure (e.g., impending herniation or requirement for immediate palliative treatment) or uncontrolled seizures or any other situation requiring urgent neurosurgical intervention.\n* History of myelodysplastic syndrome (MDS)\u002F acute myeloid leukemia (AML) or with features suggestive of MDS\u002F AML.\n* Radiographic evidence of leptomeningeal disease.\n* Received prior treatment with bevacizumab or any other cellular therapy available on or off a clinical trial.\n* Non-malignant CNS disease such as CNS vasculitis or neurodegenerative disease.\n* Prior or current GammaTile, Gliadel wafer use, or other implanted therapeutic agent or photodynamic therapy.\n* Any known condition that requires systemic immunosuppressive therapy - inhaled and topical steroids are permitted.\n* Pregnant or breastfeeding. Menstruating POCBP must have a negative pregnancy test within 14 days before the planned biopsy. Patient must agree to use highly effective method of birth control from the time of the screening visit until at least 3 months after the dose of FT536.\n* Known seropositive for HIV or known Hepatitis B or C infection with detectable viral load by PCR.\n* Prior history of malignancy within 5 years of enrollment other than basal or squamous cell carcinoma of the skin, cervical intra-epithelial neoplasia, in situ carcinoma of the breast, or prostate cancer treated with surgery or RT with a prostate specific antigen of \\\u003C0.01 ng\u002FmL tested within 28 days of trial enrollment.\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pec",{"count":470,"type":21},9,[76],"This is a single center, first-in cancer-type phase I clinical trial of FT536 for adult patients with recurrent WHO Grade 4 astrocytoma, irrespective of IDH-mutational status, for which a standard of care repeat craniotomy for gross tumor resection at time of first or second recurrence is achievable. Per this treatment schema, FT536 will be administered once intratumorally",[474,475,476],"Astrocytoma","Glioblastoma","Progressive Disease","2026-04-24",{"date":479,"type":33},"2026-05-01",{"date":481,"type":33},"2026-04-23",{"date":483,"type":21},"2029-06-01",{"name":39,"class":40},{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":22,"phases":494,"briefSummary":495,"conditions":496,"keywords":500,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":41},"100634583","phase-1-gtb-5550-in-advanced-solid-tumors-100634583","NCT07541573","GTB-5550 in Advanced Solid Tumors","MT2025-14: A Phase 1a\u002F1b Study of GTB-5550, a Camelid Nanobody TriSpecific Killer Engager (camB7-H3 TriKE®), in Select Advanced Solid Tumors That Failed Prior Therapy","Inclusion Criteria:\n\n* Measurable disease per RECIST 1.1. (Exception: mCRPC limited to bone metastasis is exempt from this requirement).\n* Age 18 years or older at the time of consent, ECOG Performance Status 0 to 2\n* Acute effects of any prior therapy must have resolved to baseline or Grade ≤ 1 NCI CTCAE v5 except for AEs not constituting a safety risk in the opinion of the enrolling Investigator.\n* Adequate organ function within 14 days (30 days for cardiac) of Cycle 1 Day 1 defined as:\n* Hematologic: hemoglobin ≥ 9 g\u002FdL (may be transfused not more than 2 units of pRBCs within 7 days prior to Cycle 1 Day 1 to meet this requirement); absolute neutrophil count (ANC) ≥ 1500\u002Ful (granulocyte colonystimulating factor (s) is not allowed to achieve ANC threshold or within 7 days of Cycle 1 Day 1); platelets ≥ 100 x 10\\^9\u002FL (may be transfused not more than 2 units of platelets within 7 days prior to Cycle 1 Day 1 to meet this requirement); absolute lymphocyte count (ALC) ≥ 300\u002Ful.\n* Albumin ≥ 3.0 g\u002FdL.\n* Renal: a patient BSA corrected glomerular filtration rate ≥ 45 mL\u002Fmin as calculated using the Modified Cockroft-Gault equation (Rostoker et al. 2007).\n* Hepatic: AST and ALT ≤1.5 x upper limit of normal (ULN) and total bilirubin ≤1.5 x ULN.\n* Cardiac: New York Heart Association (NYHA) Class I or II ; left ventricular ejection fraction (LVEF) ≥ 45% by echocardiogram, MUGA, or cardiac MRI.\n* Adequate pulmonary function with PFTs \\> 50% FEV1 if symptomatic or known impairment.\n* Sexually active couples of childbearing-potential must agree to use effective contraception or abstinence during treatment and for at least 4 months after the final dose of GTB-5550.\n* Agrees to stay within a 60-minute drive of the study center through the Cycle 1 Day 15 visit for the Phase 1a study only.\n* Provides voluntary written consent prior to the performance of any research related activity\n\nExclusion Criteria:\n\n* Anti-cancer treatment including surgery, radiotherapy, chemotherapy, other immunotherapy, or investigational therapy within 14 days prior to the 1st dose of GTB-5550. Radioligand therapy requires at least 1 cycle washout (6 weeks for Pluvicto, 4 weeks for Xofigo).\n* Prior organ allograft or allogeneic transplantation. An exception is made for FA patients with prior history of allogeneic hematopoietic stem cell transplant off immune suppressive therapy for \\> 1 year.\n* Pregnant or breastfeeding or planning pregnancy within 4 months after the last dose of GTB-5550.\n* The potential risk of QT\u002FQTc prolongation is unknown in humans receiving GTB-5550; therefore, either of the following is an exclusion criteria: QTc interval \\> 480 msec at screening and\u002For a family history of long QT syndrome.\n* Prior malignancy other than the one under treatment except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer which is currently in complete remission, or any other cancer from which the patient has been disease-free for 1 year after surgical or other definitive treatment.\n* Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 1 year or any other diseases requiring immunosuppressive therapy while on study. Inhaled or topical steroids, and adrenal replacement steroid doses ≤10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.\n* Active systemic infection requiring parenteral antibiotic therapy. Any prior systemic infections must have resolved to Grade 1 or lower following optimal therapy.\n* Psychiatric illness\u002Fsocial situations that in the judgement of the enrolling investigator would limit compliance with study requirements.\n* Other illness or a medical issue that, in the judgement of the enrolling Investigator, would exclude the patient's participation.",{"count":493,"type":21},175,[76],"This is a first-in-human Phase 1a\u002F1b trial of a B7-H3-targeted natural killer (NK) cell engager, referred to as a TriSpecific Killer Engager (TriKE), for the treatment of select solid tumor cancers. To be considered for the study, a patient must be 18 years or older, have histologically or cytologically confirmed advanced\u002Fmetastatic cancer that, based on literature reports, expresses B7-H3 at a high frequency, measurable disease by RECIST 1.1 (exception: mCRPC limited to bone metastasis are exempt from this requirement), meets the disease specific criteria for prior failed therapy, and refractory to, intolerant of, or ineligible for therapy options that are known to provide clinical benefit for their diagnosis.",[497,498,499],"Tri-specific Killer Engager","Solid Tumor","Advanced Solid Tumor",[501,502],"TriKE","GTB-5550","2026-04-20",{"date":481,"type":33},{"date":506,"type":33},"2026-04-08",{"date":508,"type":21},"2032-01",{"name":39,"class":40},{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":17,"minAge":516,"maxAge":209,"enrollmentInfo":517,"targetDuration":4,"studyType":22,"phases":519,"briefSummary":520,"conditions":521,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":41},"100630889","phase-2-mt2025-35-allogeneic-hematopoietic-stem-cell-transplantation-using-reduced-intensity-conditioning-treosulfan-and-fludarabine-with-post-transplant-cytoxan-ptcy-for-the-treatment-of-hematological-diseases-100630889","NCT07493538","MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases","Inclusion Criteria:\n\n* Patients 2-75 years of age\n* ≤7 5 years of age: Karnofsky score ≥ 70% (≥ 16 years) or Lansky play score ≥ 50 (\\\u003C 16 years) with appropriate organ criteria as below (in other inclusion criteria)\n* 5\u002F6 or 6\u002F6 related donor, OR a 5-8\u002F8 HLA-A, B, C, DRB1 allele match unrelated donor, OR a haplotype (at least 5\u002F10) related donor\n* adequate liver (no decompensated liver failure, Child Pugh A, AST\u002FALT \\\u003C5X ULN) and renal function (creatinine \\\u003C2.0)\n* absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction ≥ 40%\n* DLCO FEV1, FVC ≥ 40% predicted, and absence of O2 requirement\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Evidence of untreated\u002Funcontrolled HIV infection\n* Untreated active serious infection\n* Active CNS malignancy\n* CML in blast crisis not in a complete remission by abnormal blast count.\n* Less than 3 months since prior myeloablative transplant","2 Years",{"count":518,"type":21},132,[24],"This is a Phase II study following subjects proceeding with Treosulfan (36g\u002Fm2) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion, with post-transplant cyclophosphamide (PTCy) at 40mg\u002Fkg, tacrolimus and MMF for GVHD prophylaxis.",[234,231,287,79,124],"2026-04-13",{"date":524,"type":33},"2026-04-16",{"date":526,"type":33},"2026-04-10",{"date":528,"type":21},"2035-03",{"name":39,"class":40},{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":281,"enrollmentInfo":537,"targetDuration":4,"studyType":22,"phases":539,"briefSummary":540,"conditions":541,"keywords":557,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":41},"100495785","phase-2-mt2021-08t-cell-receptor-alphabeta-depletion-pbsc-transplantation-for-heme-malignancies-100495785","NCT05735717","MT2021-08T Cell Receptor Alpha\u002FBeta Depletion PBSC Transplantation for Heme Malignancies","Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha\u002FBeta Depletion (A\u002FB TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults With Hematological Malignancies","Inclusion Criteria:\n\n* Histological confirmation of hematological malignancies\n* Acute leukemias\n* Acute Myeloid Leukemia (AML) and related precursor neoplasms\n* Favorable risk AML is defined as having one of the following:\n* Acute lymphoblastic leukemia (ALL)\u002Flymphoma\n* Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features.\n* Age 60 years of age or younger at the time of consent\n* Karnofsky performance status ≥ 70% or Lansky play score 50% for ≤16 years of age.\n* Adequate organ function\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Active uncontrolled infection within 1 week of starting preparative therapy\n* Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR.\n* Any prior autologous or allogeneic transplant\n* CML blast crisis\n* Active central nervous system malignancy",{"count":538,"type":21},70,[24],"This is a phase II, open-label, prospective study of T cell receptor alpha\u002Fbeta depletion (TCR α\u002Fβ TCD) peripheral blood stem cell (PBSC) transplantation for children and adults with hematological malignancies. This is a safety\u002Ffeasibility study of the investigational procedure\u002Fproduct.",[542,287,543,79,288,234,80,544,545,546,547,291,302,548,549,550,551,552,553,554,555,556,299,300],"Hematologic Malignancy","Remission","Intrachromosomal Amplification of Chromosome 21","Cytogenetic Abnormality","CNS Leukemia","Minimal Residual Disease","Somatic Mutation","PTPN11 Gene Mutation","N-RAS Gene Amplification","Neurofibromatosis 1","NF1 Mutation","CBL Gene Mutation","Monosomy 7","Chromosome Abnormality","Fetal Hemoglobin",[558,559,560,561,562,361,563,564,565,566,567,568],"Bu","Flu","G-CSF","GFSR","aGVHD","MAC","Mel","PBSCT","PTLD","RECIST","TCR","2026-03-31",{"date":571,"type":33},"2026-04-06",{"date":573,"type":33},"2023-05-11",{"date":575,"type":21},"2030-11-30",{"name":39,"class":40},{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":49,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":584,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":585,"conditions":586,"keywords":588,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":41},"100488661","observational-study-of-exposure-to-environmental-toxicants-among-firefighters-100488661","NCT05643014","Observational Study of Exposure to Environmental Toxicants Among Firefighters","Evaluate the Exposure to Toxicants Emitted During a Structural Fire Assessed by Urinary and Buccal Cell Biomarkers Found in Firefighters.","Inclusion Criteria:\n\n* Firefighter (career or volunteer)\n* Over 18 years of age\n* Able to provide written voluntary consent\n\nExclusion Criteria:\n\n* Unwilling to provide a pre and post-exposure urine sample\n* Current cancer diagnosis\n* Tobacco use within the last 1 year (verified by urinary TNEs)",{"count":352,"type":21},"Observational, within subject study design with 1 pre and 2 post-fire exposure biomarker samples collected to assess exposure to toxicants from combustion emissions related to fighting a structural fire.",[587],"Healthy",[589,590,591,592],"PAH","1-HOP","PheT","SPMA","2026-03-10",{"date":595,"type":33},"2026-03-12",{"date":597,"type":33},"2020-02-01",{"date":599,"type":21},"2027-12-31",{"name":39,"class":40},{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":4,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":608,"targetDuration":4,"studyType":22,"phases":610,"briefSummary":611,"conditions":612,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":41},"100569298","phase-1-trial-of-cell-based-therapy-for-dmd-100569298","NCT06692426","Trial of Cell Based Therapy for DMD","Phase I Clinical Trial of Cell Based Therapy for Duchenne Muscular Dystrophy","Inclusion Criteria:\n\n* Duchenne muscular dystrophy, diagnosed by mutations in the DMD (dystrophin) gene and\u002For absence of immunohistochemical staining for dystrophin on muscle biopsy\n* Non-ambulatory\n* Intact extensor digitorum brevis (EDB) muscles bilaterally\n* Off investigational therapies for \\> 30 days\n* Age 18 years of age or older at the time of consent\n* Have adequate organ function confirmed by the following laboratory values obtained within 14 days prior to enrollment (28 days for cardiac and pulmonary function):\n* Participants with partners of childbearing potential must be willing to use at least two forms of effective birth control (one form must be a barrier method) while receiving the study product and for 3 months after stopping tacrolimus therapy.\n* Ability to follow commands sufficiently to perform voluntary aspects of outcome measures throughout the study period\n* Willing to consent to monitoring for 15 years, including an extension period, as required for all interventional studies involving the transplantation of cells that have been genetically modified\n* Voluntary written consent from the subject or parent(s)\u002Fguardian(s) and assent from participant prior to the performance of any research related activity.\n\nExclusion Criteria:\n\n* Presence of HLA antibodies directed toward HLA antigens on MyoPAXon\n* Active treatment with another investigational therapy\n* Known allergy to MyoPAXon components",{"count":609,"type":21},8,[76],"This is a single-center, single-arm, interventional phase 1 trial to evaluate the safety and tolerability of local injection of induced pluripotent stem cell (iPSC)- derived CD54+ allogeneic muscle progenitor cells in individuals with Duchenne muscular dystrophy (DMD)",[613],"Duchenne Muscular Dystrophy","2026-03-02",{"date":616,"type":33},"2026-03-04",{"date":618,"type":33},"2025-03-20",{"date":620,"type":21},"2027-03-03",{"name":39,"class":40},{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":4,"eligibilityCriteria":628,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":629,"targetDuration":4,"studyType":22,"phases":631,"briefSummary":632,"conditions":633,"keywords":4,"overallStatus":335,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":637,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":4},"100575423","probiotic-supplementation-during-cytotoxic-chemotherapy-for-solid-tumor-malignancies-100575423","NCT06772090","Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies","A Randomized Placebo-controlled Feasibility Trial of Probiotic Supplementation During Adjuvant or Neoadjuvant Cytotoxic Chemotherapy for Solid Tumor Malignancies","Inclusion Criteria:\n\n* Adults ≥18 years old\n* Diagnosis of stage III colon cancer\n* Undergoing chemotherapeutic treatment within the MHFV or MVAHC medical systems.\n\nExclusion Criteria:\n\n* Allergy or sensitivity to probiotic supplementation\n* Diagnosis\u002Fhistory of:\n\nNon-colon GI cancer or chronic GI-related disease or disorders such as gastric ulcer, irritable bowel syndrome, inflammatory bowel disease, or intestinal malabsorption syndrome Cognitive impairment, such as dementia, or developmental disorder that would affect ability to give consent or comply with study procedures\n\n* Current treatment of cancer other than non-melanoma skin cancer, including metastases and recurrences\n* Current participation in another interventional study of medication(s)\n* Major changes in eating habits within the past 3 months, such as stopping or starting a restricted diet\n* BMI ≥40 kg\u002Fm2 or ≤17 kg\u002Fm2\n* Unexpected change in weight of ˃4.5 kg within the past 6 months",{"count":630,"type":21},40,[54],"This is a pilot single-blind placebo-controlled randomized trial to establish experimental feasibility. We plan on enrolling a pilot cohort of 40 patients, with up to 5 patients in treatment phase 0 and the remaining in treatment phase I. During Phase I, the remaining participants will be assigned to either treatment or control group using dynamic block randomization balancing on sex, age group, and disease histology.",[634,635],"Solid Tumor, Adult","Cytotoxicity","2026-02-02",{"date":638,"type":33},"2026-02-03",{"date":640,"type":21},"2026-12-25",{"date":642,"type":21},"2028-12-31",{"name":39,"class":40},{"id":645,"slug":646,"hasResults":12,"nctId":647,"briefTitle":648,"officialTitle":649,"acronym":4,"eligibilityCriteria":650,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":651,"targetDuration":4,"studyType":22,"phases":653,"briefSummary":654,"conditions":655,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":658,"startDateStruct":659,"completionDateStruct":661,"leadSponsor":663,"locationsCount":41},"100547732","phase-2-rectus-sheath-block-with-liposomal-bupivacaine-versus-thoracic-epidural-analgesia-for-pain-control-following-pancreatoduodenectomy-100547732","NCT06411795","Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy","Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy: A Prospective, Randomized, Non-Inferiority Trial","Inclusion Criteria:\n\n* Adult patients, age 18 and older, undergoing open pancreaticoduodenectomy at the University of Minnesota will be included in the study\n\nExclusion Criteria:\n\n* Patients with contraindication to block placement (coagulopathy, local anesthetic allergy, infection)\n* Patients with chronic opioid use (at least 30 milligram morphine equivalents \\[MME\\] for 3 or more weeks leading up to surgery)\n* Patients unable to understand the quality of recovery survey intellectual barriers. This will be determined by the primary investigator\u002Fattending anesthesiologist's discretion\n* Patient refusal and those who have opted out of research\n* Pregnant patients - will be assessed through review of the medical record",{"count":652,"type":21},78,[24],"This phase II trial compares the effect of rectus sheath block with liposomal bupivacaine to thoracic epidural analgesia (TEA) on pain control in patients following surgical removal of all or part of the pancreas and duodenectomy (pancreatoduodenectomy). Administering long acting local anesthetics, such as liposomal bupivacaine, in between the muscle layers of the abdomen (rectus sheath block) may help with pain relief during and after surgery. TEA uses a needle to insert a flexible plastic catheter into the thoracic spine to administer anesthetic and pain medication, such as bupivacaine and hydromorphone, to treat pain in the thoracic and upper abdominal areas during and after surgery. Epidurals have been successfully used to treat pain after surgery, however, it does have a risk of low blood pressure which may limit the use in the thoracic approach. Rectus sheath blocks with liposomal bupivacaine may be as effective as TEA in reducing pain in patients following a pancreatoduodenectomy.",[656,657],"Duodenal Neoplasm","Pancreatic Neoplasm",{"date":638,"type":33},{"date":660,"type":33},"2023-11-10",{"date":662,"type":21},"2028-01-01",{"name":39,"class":40},""]