[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620482":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":37,"locations":43,"responsibleParty":58,"collaborators":23,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":23,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":23,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":23,"overallStatus":85,"whyStopped":23,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Recipient","EXPERIMENTAL","Stem Cell and Kidney Transplant",[13,14,15,16],"Drug: Venetoclax","Procedure: Hematopoietic Cell Transplantation Conditioning Regimen","Procedure: Kidney Transplant","Procedure: Hematopoietic Cell Transplantation",[18,24,29,33],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Venetoclax","Venetoclax 400mg orally once daily on days -8 through -1 with daily monitoring for tumor lysis syndrome. Venetoclax tablets will be swallowed (not crushed). Venetoclax dosing will not be repeated in the event of vomiting.",[9],null,{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":23},"PROCEDURE","Hematopoietic Cell Transplantation Conditioning Regimen","Cytoxan Day -6 \\& -5 Fludarabine Day -4, -3, -2 TBI Day -1",[9],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":23},"Kidney Transplant","Living donor kidney transplant",[9],{"type":25,"name":34,"description":35,"armGroupLabels":36,"otherNames":23},"Hematopoietic Cell Transplantation","Donor bone marrow (target of 4 x 108 nucleated cells\u002Fkg of recipient ideal body weight)\n\nPBSC A goal dose of 5 x 106 CD34+ cells \u002F kg of recipient actual body weight will be infused (minimum acceptable is 2 x 106 CD34+ cells \u002F kg).",[9],[38],{"name":39,"role":40,"phone":41,"phoneExt":23,"email":42},"Thomas Spitzer, MD","CONTACT","617-724-1124","tspitzer@mgh.harvard.edu",[44],{"facility":5,"status":23,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Boston","Massachusetts","02114","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-71.05977,42.35843,{"lat":54,"lon":53},[57],{"name":39,"role":40,"phone":41,"phoneExt":23,"email":42},{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Thomas Spitzer","Professor of Medicine, Harvard Medical School Director Emeritus, Bone Marrow Transplant Program","100620482","early-phase-1-addition-of-venetoclax-to-combined-hematopoietic-stem-cell-and-kidney-transplantation-100620482",false,"NCT07358195","Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation","Addition of Venetoclax to Combined Reduced Intensity Hematopoietic Stem Cell and Kidney Transplantation for Patients With Chronic Kidney Disease and Hematologic Malignancy","Recipient Inclusion Criteria:\n\n* Patient ages 18-70\n* Underlying hematological malignancy which is deemed as being potentially curable with allogeneic bone marrow or PBSC transplantation by the BMT voting team.\n* Hematological malignancies include, but are not limited to: acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myelogenous leukemia (CML), chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma (NHL), Hodgkin lymphoma, multiple myeloma (MM), myelodysplastic syndrome (MDS. Patient should be in a partial (PR) or complete remission (CR) at the time of the transplant.\n* Existence of an HLA-matched or haploidentical relative who passes standard donor evaluations for bone marrow and kidney donation\n* LVEF \\> 40% as measured by echocardiography or MUGA\n* FEV1, FVC, and DLCO \\> 50% of predicted as measured by standard PFTs\n* Total bilirubin \\\u003C 2.0 (unless diagnosis of Gilbert's or hemolysis is made) and AST, ALT, alkaline phosphatase all \\\u003C 5x institutions upper limit of normal\n* ABO compatibility in the host vs. graft direction\n* Men and women of reproductive potential must agree to use a reliable method of birth control during the treatment, and women should do so for a period of 1 year following the transplant.\n* Participants should be on dialysis or have a CrCl ≤ 35 ml\u002Fmin\n* Life expectancy greater than 6 months\n* Recipient ability to understand and provide informed consent\n\nDonor Inclusion Criteria:\n\n* HLA matched or haploidentical relative as defined by 3\u002F6, 4\u002F6, or 5\u002F6 HLA-matched at HLA -A, -B, or -DRB1 who is 18-70 years of age\n* ECOG performance status 0 or 1\n* Excellent health per conventional pre-donor history (medical and psychosocial evaluation)\n\n  • Acceptable laboratory parameters (hematology in normal or near-normal range; liver function \\\u003C 3 times the upper limit of normal and normal creatinine)\n* Compatible ABO blood group\n* Negative donor lymphocyte cross match\n* No positive testing for active viral infection (Hepatitis B, Hepatitis C, HIV)\n* Donor ability to understand and provide informed consent\n* Meets standard institutional criteria for both bone marrow or peripheral blood stem cell (PBSC) and kidney donation\n\nExclusion Criteria:\n\n* Active serious infection\n* Participation in other investigational drug use at the time of enrollment\n* Positivity for active infection with HIV, HCV, or HBV\n* ABO blood group incompatibility in the host-vs-graft direction","ALL","18 Years","70 Years",{"count":73,"type":74},3,"ESTIMATED","INTERVENTIONAL",[77],"EARLY_PHASE1","The primary objective is to assess the safety of the addition of venetoclax to reduced intensity conditioning for HLA-matched and haploidentical combined HSC and kidney transplantation as measured by stable full donor hematopoiesis and absence of CTCAE grade IV or V toxicity attributable to venetoclax.",[80,81,82,83,84],"Kidney Failure Chronic","Stem Cell Transplant","Stem Cell Transplant Complications","Tolerance","Hematologic Cancer","NOT_YET_RECRUITING","2026-01-13",{"date":88,"type":89},"2026-01-22","ACTUAL",{"date":91,"type":74},"2026-07",{"date":93,"type":74},"2029-12",{"name":5,"class":6},1]