[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"allogeneic-stem-cell-transplantation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:allogeneic-stem-cell-transplantation":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,49,63,90,120,154,180,208],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100053350","phase-3-fibrotic-disease-activity-in-cardiopulmonary-disorders-using-18f-fibroblast-activation-protein-inhibitor-18f-fapi-74-petct-imaging-100053350",false,"NCT07613099","Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) PET\u002FCT Imaging","Evaluation of Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74 PET\u002FCT Imaging)","* INCLUSION CRITERIA\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Participant \\>=18 years old\n4. Has a specific diagnosis of a cardiopulmonary and\u002For vascular disease that puts them at risk of developing or having developed tissue fibrosis.\n5. Has undergone prior imaging of lungs, heart, and\u002For vasculature with chest CT\n6. Able to lie on the PET\u002FCT scanner for imaging up to 45 minutes.\n7. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of FAPI-PET\u002FCT or the FDG PET\u002FCT scan.\n8. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 4 weeks after the end of FAPI-PET\u002FCT or the FDG PET\u002FCT scan.\n9. Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FAPI-74 or other agents used in the study.\n2. Uncontrolled intercurrent illness, factors, or social situations that would limit compliance with study requirements\n3. Pregnancy or lactation\n4. Women able to become pregnant or men actively trying to father a child and are unwilling to use an effective form of birth control during the study and 4 weeks after the last 18F-FAPI-74 PET\u002FCT scan or the FDG PET\u002FCT scan.\n5. Subjects with severe claustrophobia unresponsive to oral anxiolytics.\n6. Subjects weighing \\> 350 lbs (weight limit for PET scanner table), or unable to fit within the imaging gantry","ALL","18 Years","100 Years",{"count":20,"type":21},210,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Background:\n\nInjury or diseases of the heart and lung can sometimes cause scar tissue (fibrosis) to build up in those organs. Current imaging scans can see this scar tissue once it has formed, but researchers want to find a way to detect the fibrosis in its earliest stages, while there might still be time to prevent serious damage. A new tracer (a radioactive substance injected during imaging scans) may be able to help.\n\nObjective:\n\nTo test a new tracer (18F-FAPI-74) during imaging scans in people with heart or lung disease.\n\nEligibility:\n\nPeople aged 18 years and older with lung or heart disease that may cause scarring in those organs.\n\nDesign:\n\nParticipants will have 6 clinic visits over 2 years.\n\nParticipants will be screened: They will have blood tests and tests of their heart and lung function. Those with heart disease will have a magnetic resonance imaging (MRI) scan of the heart.\n\nThe study tracer will be used with positron emission tomography (PET)\u002Fcomputed tomography (CT) scans. The study tracer will be injected into a vein in the arm. Participants will lie on a padded bed that slides through a donut-shaped machine.\n\nParticipants will have scans with the study tracer 2 times, 8 to 12 months apart. They will also have standard CT scans and blood tests during these visits. They will also have blood tests at 3 and 6 months between these visits.\n\nParticipants will have a follow-up visit after 18 to 24 months. The study scans, MRI and standard CT scans, and lung function tests may be repeated....",[27,28,29,30,31,32],"Allogeneic Stem Cell Transplantation","Lung Allograft Transplantation","Interstitial Lung Disease","Acute Lung Injury","Pulmonary Arterial Hypertension","Cardiovascular Diseases",[34,35],"Fibroblast activation protein (FAP) FAPI\u002FPET","Fibrotic Disease Activity","NOT_YET_RECRUITING","2026-07-10",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":21},"2026-07-16",{"date":44,"type":21},"2033-05-26",{"name":46,"class":47},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",1,{"id":50,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":62,"locationsCount":48},"100641631",{"count":20,"type":21},[24],"Background:\n\nInjury or diseases of the heart and lung can sometimes cause scar tissue (fibrosis) to build up in those organs. Current imaging scans can see this scar tissue once it has formed, but researchers want to find a way to detect the fibrosis in its earliest stages, while there might still be time to prevent serious damage. A new tracer (a radioactive substance injected during imaging scans) may be able to help.\n\nObjective:\n\nTo test a new tracer (18F-FAPI-74) during imaging scans in people with heart or lung disease.\n\nEligibility:\n\nPeople aged 18 years and older with lung or heart disease that may cause scarring in those organs.\n\nDesign:\n\nParticipants will have 6 clinic visits over 2 years.\n\nParticipants will be screened: They will have blood tests and tests of their heart and lung function. Those with heart disease will have a magnetic resonance imaging (MRI) scan of the heart.\n\nThe study tracer will be used with positron emission tomography (PET)\u002Fcomputed tomography (CT) scans. The study tracer will be injected into a vein in the arm. Participants will lie on a padded bed that slides through a donut-shaped machine.\n\nParticipants will have scans with the study tracer 2 times, 8 to 12 months apart. They will also have standard CT scans and blood tests during these visits. They will also have blood tests at 3 and 6 months between these visits.\n\nParticipants will have a follow-up visit after 18 to 24 months. The study scans, MRI and standard CT scans, and lung function tests may be repeated.",[27,28,29,30,31,32],[34,35],"2026-07-01",{"date":58,"type":40},"2026-07-02",{"date":60,"type":21},"2026-07-07",{"date":44,"type":21},{"name":46,"class":47},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":48},"100587300","phase-2-allogeneic-hsct-with-low-dose-post-transplant-cyclophosphamide-for-gvhd-prevention-100587300","NCT06926595","Allogeneic HSCT With Low-Dose Post-Transplant Cyclophosphamide for GVHD Prevention","Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) With Low-Dose Post-Transplant Cyclophosphamide for Prophylaxis of Graft-versus-Host Disease in Hematological Malignancies","GVHD-PTCy","Inclusion Criteria:\n\n* Age 18 or older at the time of study enrollment.\n* Patients with acute leukemia (acute myeloid leukemia, acute lymphoblastic leukemia, mixed phenotype acute leukemia) or chronic myeloid leukemia with no circulating blasts and less than 5% blasts in the bone marrow.\n\nFlow cytometric, polymerase chain reaction (PCR) or next generation sequencing (NGS) detected measurable residual disease is permitted.\n\n* Patients with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia with no circulating blasts and less than 10% blasts in the bone marrow (exception allowed due to lack of difference in outcomes with \\\u003C5% vs 5-10% blasts in this disease).\n* Patients with secondary acute myeloid leukemia progressing from pre-existing myelodysplastic syndrome, myeloproliferative disease (MPN), or MDS\u002FMPN overlap syndrome.\n* Patients with relapsed or refractory chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma who are indicated for allogeneic stem cell transplantation.\n* Patients with lymphoma who are indicated for allogeneic stem cell transplantation, including follicular lymphoma, Hodgkin lymphoma, diffuse large B cell lymphoma (including primary mediastinal B cell lymphoma), mantle cell lymphoma, peripheral T cell lymphomas, and Richter's transformation.\n* Planned reduced intensity or non-myeloablative conditioning regimen.\n* Patients must have a related or unrelated peripheral blood stem cell donor as follows:\n\nSibling donor must be at least haploidentical using high resolution DNA-based HLA typing.\n\nChildren or parent donor must be at least haploidentical using high resolution DNA-based HLA typing. Children donors must be at least 18 years of age at the time of evaluation.\n\nUnrelated donors must be a 7\u002F8 or 8\u002F8 match at HLA-A, B, C, and DRB1 at high resolution using DNA based typing.\n\n* Cardiac function: must demonstrate at ejection fraction of at least 40%.\n* Pulmonary function: must have FEV1 of at least 50% predicted, and DLCO corrected for hemoglobin of at least 40% predicted.\n* Karnofsky performance status at least 70%.\n* Women of childbearing potential (WOCP), defined as not surgically sterile (hysterectomy, tubal ligation, or oophorectomy) or at least 1 year postmenopausal, must have a negative serum pregnancy test before conditioning regimen.\n* Female patients (unless post-menopausal or surgically sterilized) must agree to practice two effective methods of contraception simultaneously or agree to completely abstain from heterosexual intercourse from the time of signing informed consent through 12 months post-transplant.\n* Male patients (even if surgically sterilized) who are partners of women of childbearing potential must agree to practice effective barrier contraception or abstain from heterosexual intercourse from the time of signing the informed consent through 12 months post-transplant.\n\nExclusion Criteria:\n\n* Prior allogeneic stem cell transplant.\n* Active central nervous system (CNS) involvement by malignant cells.\n* Uncontrolled bacterial, viral, or fungal infections (currently taking medication with progression or no clinical improvement).\n* Seropositive for human immunodeficiency virus (HIV) with detectable viral load, hepatitis B virus (HBV) or hepatitis C virus (HCV) with detectable viral load. Hepatitis B surface antibody positive due to vaccination or natural immunity are permitted. Patients previously treated for HCV and considered to be in sustained virologic remission (SVR) are allowed.\n* Myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) class III-IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.\n* Pregnant or lactating female patients (unless feeding via formula). Women of childbearing potential (WOCBP) are required to have a negative serum or urine pregnancy test prior to conditioning regimen.\n* Serious medical or psychiatric illness likely to interfere with participation in the study.\n* Use of investigational agents.\n* Haploidentical related recipient who are positive for DSA ≥ 5000 MFI by solid phase microarray method (Luminex).\n* Any patient with steroid dose more than 10 mg\u002Fday within a week of registration.\n* Autoimmune disorder requiring any active immunosuppression therapy.",{"count":72,"type":21},41,[74],"PHASE2","This Phase 2, single-arm, open-label study aims to evaluate the safety and efficacy of low-dose (25 mg\u002Fkg) post-transplant cyclophosphamide (PTCy) for prophylaxis of Graft-versus-Host Disease (GVHD) in patients undergoing allogeneic stem cell transplantation following reduced-intensity or non-myeloablative conditioning. The study will focus on matched sibling, matched unrelated, and haploidentical peripheral blood stem cell donors. The primary endpoint is 1-year GVHD-Free Relapse-Free Survival (GRFS). The study seeks to determine if low-dose PTCy offers similar outcomes as higher doses, with potentially reduced toxicity.",[77,78,27],"Graft-versus-Host Disease (GVHD)","Hematologic Malignancies","RECRUITING","2026-03-30",{"date":82,"type":40},"2026-04-03",{"date":84,"type":40},"2026-03-09",{"date":86,"type":21},"2031-11-01",{"name":88,"class":89},"Milton S. Hershey Medical Center","OTHER",{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":48},"100518306","phase-2-risk-adapted-conditioning-regimen-for-allogeneic-hematopoietic-stem-cell-transplantation-100518306","NCT06028828","Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation","Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation (ADAPT)","ADAPT","Inclusion Criteria:\n\n1. Male or female aged 18-70 years\n2. Diagnosis of AML, ALL, MDS, CML, NHL, HD, CLL requiring AHSCT\n3. Has an HLA-matched related (MRD), HLA-matched unrelated (MUD), haploidentical (HAPLO) or 1-Ag mismatched unrelated donor (MMUD)\n4. Karnofsky performance \\>70%\n5. Adequate major organ system function as demonstrated by:\n\n   1. Serum creatinine clearance equal or more than 50 ml\u002Fmin (calculated with Cockroft-Gault formula).\n   2. Bilirubin equal or less than 1.5 mg\u002Fdl except for Gilbert's disease. ALT or AST equal or less than 200 IU\u002Fml for adults. Conjugated (direct) bilirubin less than 2x upper limit of normal.\n   3. Left ventricular ejection fraction equal or greater than 40%.\n   4. Diffusing capacity for carbon monoxide (DLCO) equal or greater than 50% predicted corrected for hemoglobin.\n6. Ability to understand and the willingness to sign a written informed consent. a. Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial.\n\nExclusion Criteria:\n\n1. Inability to comply with medical recommendations or follow-up\n2. Pregnancy\n3. Active\u002Funcontrolled bacterial or viral infection (PI is the final arbiter of this criterion.)\n4. Has active CNS or ocular disease involvement within 3 months\n5. Patients with primary CNS lymphoma\n6. Patients who require modifications of the conditional regimen","70 Years",{"count":100,"type":21},60,[74],"This is a prospective, single-arm, phase II study. Patients will be treated with an allogeneic stem cell transplantation (AHSCT) using fludarabine, melphalan and total body irradiation (TBI) conditioning with different melphalan and TBI doses based on patient- and disease-related risk.",[104,27,78],"Allogeneic Hematopoietic Stem Cell Transplantation",[104,106,107,108,109,110],"Allogeneic Stem Cell transplantation","AHSCT","Hematologic malignancies","Melphalan","Hematopoietic stem cell transplant -composite risk","2026-01-29",{"date":113,"type":40},"2026-02-02",{"date":115,"type":40},"2023-09-11",{"date":117,"type":21},"2027-09",{"name":119,"class":89},"University of California, Irvine",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":129,"phases":4,"briefSummary":130,"conditions":131,"keywords":138,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":153},"100145560","cibmtr-research-database-100145560","NCT01166009","CIBMTR Research Database","Protocol For A Research Database For Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries","Eligibility to Participate in the Research Database\n\nRecipient Eligibility Criteria:\n\n* Any recipient of an unrelated or related donor or autologous HSC transplant in a CIBMTR center is eligible to participate in the Research Database. This includes adults with and without decision making capacity, and children.\n\nIndividual with Marrow Toxic Injury Eligibility Criteria:\n\n* Any individual who is treated for a marrow toxic injury at a center participating in the NMDP's Radiation Injury Transplant Network (RITN) is eligible to participate in the Research Database. This includes adults with and without decision making capacity, and children. Eligible individuals may have received supportive care only, growth factor support, HSC transplant or other appropriate medical treatment for marrow toxic injury. Treatments applied are at the discretion of the care facility, and are not determined by the NMDP or CIBMTR.\n\nUnrelated Donor Eligibility Criteria:\n\n* All donors registered on the NMDP Registry who have been requested to donate a product for a recipient are eligible to participate in the Research Database.\n* All maternal cord blood donors are enrolled in the NMDP Cord Blood Bank Investigational New Drug (IND) protocol, and sign an informed consent document specific to that protocol. Data collected as part of the Cord Blood Bank protocol are included in the Research Database.",{"count":128,"type":21},99999999,"OBSERVATIONAL","The primary purpose of the Research Database is to have a comprehensive source of observational data that can be used to study HSC transplantation and cellular therapies.\n\nA secondary purpose of the Research Database is to have a comprehensive source of data to study marrow toxic injuries.\n\nObjectives:\n\nTo learn more about what makes stem cell transplants and cellular therapies work well such as:\n\n* Determine how well recipients recover from their transplants or cellular therapy;\n* Determine how recovery after a transplant or cellular therapy can be improved;\n* Determine how a donor's or recipient's genetics impact recipient recovery after a transplant or cellular therapy;\n* Determine how access to transplant or cellular therapy for different groups of patients can be improved;\n* Determine how well donors recover from the collection procedures.",[132,27,133,134,135,136,137],"Autologous Stem Cell Transplantation","Solid Tumors","Blood Cancers","CAR-T","Gene Therapy","Non-malignant Disease",[139,140,141,142,136,135],"Data Collection","CIBMTR","NMDP","Stem Cell Transplantation","2025-08-07",{"date":145,"type":40},"2025-08-12",{"date":147,"type":4},"2002-07",{"date":149,"type":21},"2050-07",{"name":151,"class":152},"Center for International Blood and Marrow Transplant Research","NETWORK",2,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":22,"phases":163,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":48},"100550928","phase-2-cmv-tcip-directed-letermovir-prophylaxis-after-allo-sct-100550928","NCT06453460","CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT","Prospective Evaluation of Efficacy of CMV-specific T Cell Immunity (CMV-TCIP) Directed Letermovir Prophylaxis After Allogeneic Hematopoietic Cell Transplantation","Inclusion Criteria:\n\n* ≥ 18 years of age on the day of signing informed consent.\n* Karnofsky performance \\>70%\n* Have documented seropositivity for CMV (either donor or recipient CMV IgG seropositivity) before AHCT.\n* Eligible for AHCT from an HLA-matched related, matched unrelated, mismatched unrelated or haploidentical donor using either bone marrow or peripheral blood stem cells.\n* Have undetectable CMV DNA from a plasma sample collected within 5 days prior to enrollment.\n* Must be within Day-10 thru Day+28 days of planned HSCT at the time of enrollment.\n* Be able to comply with medical recommendations or follow-up.\n* Has adequate organ functions determined by\n\n  1. Serum creatinine clearance ≥50 ml\u002Fmin (calculated with Cockroft-Gault formula).\n  2. Bilirubin ≤1.5 mg\u002Fdl except for Gilbert's disease.\n  3. ALT or AST ≤200 IU\u002Fml for adults.\n  4. Conjugated (direct) bilirubin \\\u003C 2x upper limit of normal.\n  5. Left ventricular ejection fraction ≥40%.\n  6. Diffusing capacity for carbon monoxide (DLCO) ≥ 50% predicted corrected for hemoglobin.\n\nExclusion Criteria:\n\n* Has a history of CMV end-organ disease or CS-CMVi within 6 months prior to enrollment.\n* Received within 7 days prior to screening or plans to receive during the study any of the following:\n\n  1. Ganciclovir\n  2. Valganciclovir\n  3. Foscarnet\n  4. Acyclovir (\\> 3200 mg PO per day or \\> 25 mg\u002Fkg IV per day)\n  5. Valacyclovir (\\> 3000 mg\u002Fday)\n  6. Famciclovir (\\> 1500 mg\u002Fday)\n* Received within 30 days prior to screening or plans to receive during the study any of the following drugs: cidofovir, CMV hyper-immune globulin, any investigational CMV antiviral agent\u002Fbiologic therapy.\n* Has suspected or known hypersensitivity to active or inactive ingredients of letermovir formulations.\n* Has an uncontrolled infection\n* Requires mechanical ventilation or is hemodynamically unstable",{"count":162,"type":21},50,[74],"This is a phase 2, prospective cohort clinical trial evaluating the utilization of CMV T Cell Immunity Panel (CMV-TCIP) assay to guide the duration of primary CMV prophylaxis in CMV-seropositive recipients of allogeneic stem cell transplant or recipients receiving a stem cell graft from a CMV serology positive donor.",[166,27],"CMV",[168,169,170,171],"CMV T Cell Immunity Panel","CMV reactivation","Allogeneic stem cell transplantation","Letermovir","2025-07-03",{"date":174,"type":40},"2025-07-09",{"date":176,"type":40},"2024-06-27",{"date":178,"type":21},"2029-06",{"name":119,"class":89},{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":22,"phases":190,"briefSummary":192,"conditions":193,"keywords":195,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":207},"100514728","phase-1-trial-of-an-investigational-drug-after-rejecting-the-relapse-of-an-allogeneic-transplant-100514728","NCT05982275","Trial of an Investigational Drug After Rejecting the Relapse of an Allogeneic Transplant","Anti-BCMA Chimeric Antigen Receptor (CARTemis-1) T-lymphocyte Therapy in the Treatment of Patients With Multiple Myeloma in Relapse After Allogeneic Transplant: Endothelial Growth Factor Receptor Expression as a Control Mechanism of Treatment-derived Complications","CARTemis-1","Inclusion Criteria:\n\n1. Patients \\> 18 years old with a diagnosis of post-allogeneic transplant relapse multiple myeloma.\n2. Measurable disease at the time of screening\n3. Previous treatment with ≥2 lines before and\u002For after allogeneic transplant.\n4. Patients who are not receiving immunosuppressants at least 1 month before inclusion and who do not have active graft-versus-host disease.\n5. Eastern Cooperative Oncology Group functional status from 0 to 1.\n6. Life expectancy greater than 3 months (at the time of screening)\n7. Patients who give their consent by signing the Informed Consent document.\n\nExclusion Criteria:\n\n1. Active systemic immunosuppressive treatment\n2. Patients who have previously received treatment with CAR-T Anti-BCMA.\n3. Absolute lymphocyte count \\\u003C0.2x109\u002FL\n4. Previous neoplasm, except if it has been in complete remission \\>3 years, with the exception of skin carcinoma (non-melanoma)\n5. Active infection requiring treatment.\n6. Active HIV, hepatitis B virus or hepatitis C virus infection.\n7. Uncontrolled medical illness.\n8. Severe organic disease that meets any of the following criteria: left ventricular ejection fraction \\\u003C40%, carbon monoxide diffusion test \\\u003C40%, glomerular filtration rate \\\u003C50 ml\u002Fmin, bilirubin \\>3 normal value (except Gilbert syndrome).\n9. Previous diagnosis of symptomatic amyloid light chain or primary amyloidosis or POEMS Syndrome.\n10. Pregnant or lactating women.\n11. Women of childbearing age, unable or unwilling to use highly effective contraceptive methods.\n12. Men who cannot or do not wish to use highly effective contraceptive methods. The partner of the male participants, if they are women of childbearing age, must also use highly effective contraceptive methods during the study period.\n13. Contraindication to receive lymphodepleting chemotherapy.\n14. Patients with known hypersensitivity to the active ingredients or any of the excipients of the product to be infused.",{"count":189,"type":21},25,[191,74],"PHASE1","Most patients with multiple myeloma (MM) die due to relapse resistant to current treatment, including treatment with anti-B cell maturation antigen (BCMA) CAR-T cells. To overcome some of the potential limitations of this therapy, a new and optimized Anti-BCMA CAR-T has been developed, with the aim of using it in patients with MM who relapse after Allogeneic Haematopoietic Haematopoietic Progenitor. This trial is a prospective phase I\u002FII trial with a 3+3 design. Once Dose Limiting Toxicity is identified, Phase II will begin to assess the efficacy of the procedure.",[194,27],"Multiple Myeloma",[196,197],"Chimeric antigen receptor-T cell therapy","B-Cell Maturation Antigen","2024-05-13",{"date":200,"type":40},"2024-05-14",{"date":202,"type":21},"2024-12-30",{"date":204,"type":21},"2029-12-31",{"name":206,"class":89},"Fundación Pública Andaluza para la gestión de la Investigación en Sevilla",5,{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":129,"phases":4,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":48},"100433157","protocol-for-a-research-sample-repository-for-hematopoietic-cell-transplantation-other-cellular-therapies-and-marrow-toxic-injuries-100433157","NCT04920474","Protocol for a Research Sample Repository for Hematopoietic Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries","Eligibility to participate in the Research Sample Repository Protocol:\n\nHematopoietic Cell (HC) or Other Cellular Therapy Donors\n\n* Donors are eligible to participate in the Research Sample Repository if they have donated or are scheduled to donate HCs or cellular therapy products to an allogeneic recipient either by a marrow harvest or by apheresis. This includes adults with and without decision making capacity and children.\n* All donors registered on the National Marrow Donor Program (NMDP) Registry, regardless of whether they have been requested to donate a product for a patient, are eligible to participate in the Research Sample Repository.\n\nCord Blood Units (CBUs)\n\n* Testable material from CBUs (Specimens) infused at treatment centers covered under the C. W. Bill Young Transplantation Program are eligible for inclusion in the Research Sample Repository. Material may be submitted by participating treatment centers, centralized laboratories and Cord Blood Banks.\n\nHematopoietic Cell Transplantation or Other Cellular Therapy Recipients\n\n* All U.S. recipients of allogeneic or autologous HC transplants or cellular therapies are eligible to participate in the Research Sample Repository. This includes adults with and without decision making capacity and children.\n\nPatients with Marrow Toxic Injury\n\n* Any patient who is treated for a marrow toxic injury at a center participating in the NMDP's Radiation Injury Treatment Network (RITN) is eligible to participate in the Research Sample Repository. This includes adults with and without decision-making capacity and children.\n* Eligible patients may have received support care only, growth factor support, hematopoietic stem cell transplant or other appropriate medical treatment for marrow toxic injury",{"count":128,"type":21},"The primary purpose of the Research Sample Repository is to make blood samples available for research studies related to histocompatibility and hematopoietic cell transplantation (HCT) or other cellular therapy.\n\nRepresentatives of participating centers and investigators or research groups may request access to research samples contained in the Research Sample Repository for the purpose of conducting research including:\n\n* investigating molecular explanations for histocompatibility or clinical outcomes through analysis of genomic, epigenetic, or other biomolecular data\n* evaluating the factors that affect transplant or cellular therapy outcome\n* studying the distribution of HLA tissue types in different populations\n* studying the success of transplantation, cellular therapies or supportive care in the management of marrow toxic injuries\n* performing de-linked (anonymous) research",[132,27,217,218],"Cellular Therapy","Marrow Toxic Injury","2023-05-01",{"date":221,"type":40},"2023-05-03",{"date":223,"type":40},"1991-07",{"date":225,"type":21},"2030-07",{"name":151,"class":152}]