Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 4:14 AM
Study NCT ID:
NCT07358195
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-22
First Post:
2026-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C579720', 'term': 'venetoclax'}, {'id': 'D016030', 'term': 'Kidney Transplantation'}, {'id': 'D033581', 'term': 'Stem Cell Transplantation'}], 'ancestors': [{'id': 'D017582', 'term': 'Renal Replacement Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016377', 'term': 'Organ Transplantation'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-13', 'studyFirstSubmitDate': '2026-01-05', 'studyFirstSubmitQcDate': '2026-01-13', 'lastUpdatePostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of full donor chimerism', 'timeFrame': '24 months'}, {'measure': 'Incidence of Grade IV Toxicity due to Venetoclax', 'timeFrame': 'Days -8 to Days -1', 'description': 'NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0'}, {'measure': 'Incidence of Grade V Toxicity due to Venetoclax', 'timeFrame': 'Days -8 to Days -1', 'description': 'NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0'}], 'secondaryOutcomes': [{'measure': 'Incidence of acute renal allograft rejection', 'timeFrame': '24 months'}, {'measure': 'Incidence of delayed renal allograft rejection', 'timeFrame': '24 months'}, {'measure': 'Incidence of acute GVHD', 'timeFrame': '24 months'}, {'measure': 'Incidence of Chronic GVHD', 'timeFrame': '24 months'}, {'measure': 'Patient Survival Rate', 'timeFrame': '24 months'}, {'measure': 'Allograft Survival Rate', 'timeFrame': '24 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Failure Chronic', 'Stem Cell Transplant', 'Stem Cell Transplant Complications', 'Tolerance', 'Hematologic Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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 \\< 2.0 (unless diagnosis of Gilbert's or hemolysis is made) and AST, ALT, alkaline phosphatase all \\< 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/min\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 3/6, 4/6, or 5/6 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 \\< 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"}, 'identificationModule': {'nctId': 'NCT07358195', 'briefTitle': 'Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Addition of Venetoclax to Combined Reduced Intensity Hematopoietic Stem Cell and Kidney Transplantation for Patients With Chronic Kidney Disease and Hematologic Malignancy', 'orgStudyIdInfo': {'id': 'DFCC 25-668'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Recipient', 'description': 'Stem Cell and Kidney Transplant', 'interventionNames': ['Drug: Venetoclax', 'Procedure: Hematopoietic Cell Transplantation Conditioning Regimen', 'Procedure: Kidney Transplant', 'Procedure: Hematopoietic Cell Transplantation']}], 'interventions': [{'name': 'Venetoclax', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Recipient']}, {'name': 'Hematopoietic Cell Transplantation Conditioning Regimen', 'type': 'PROCEDURE', 'description': 'Cytoxan Day -6 \\& -5 Fludarabine Day -4, -3, -2 TBI Day -1', 'armGroupLabels': ['Recipient']}, {'name': 'Kidney Transplant', 'type': 'PROCEDURE', 'description': 'Living donor kidney transplant', 'armGroupLabels': ['Recipient']}, {'name': 'Hematopoietic Cell Transplantation', 'type': 'PROCEDURE', 'description': 'Donor bone marrow (target of 4 x 108 nucleated cells/kg of recipient ideal body weight)\n\nPBSC A goal dose of 5 x 106 CD34+ cells / kg of recipient actual body weight will be infused (minimum acceptable is 2 x 106 CD34+ cells / kg).', 'armGroupLabels': ['Recipient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'contacts': [{'name': 'Thomas Spitzer, MD', 'role': 'CONTACT', 'email': 'tspitzer@mgh.harvard.edu', 'phone': '617-724-1124'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Thomas Spitzer, MD', 'role': 'CONTACT', 'email': 'tspitzer@mgh.harvard.edu', 'phone': '617-724-1124'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine, Harvard Medical School Director Emeritus, Bone Marrow Transplant Program', 'investigatorFullName': 'Thomas Spitzer', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}