[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586633":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":157,"centralContacts":41,"locations":162,"responsibleParty":419,"collaborators":41,"id":421,"slug":422,"hasResults":423,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":41,"eligibilityCriteria":427,"healthyVolunteers":423,"sex":428,"minAge":429,"maxAge":430,"enrollmentInfo":431,"targetDuration":41,"studyType":434,"phases":435,"briefSummary":437,"conditions":438,"keywords":41,"overallStatus":165,"whyStopped":41,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":449},{"fullName":5,"class":6},"National Cancer Institute (NCI)","NIH",[8,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Regimen 1 (gemtuzumab ozogamicin 7+3)","EXPERIMENTAL","Patients receive gemtuzumab ozogamicin IV on days 1 and 4, cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation\u002Fpost-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.",[13,14,15,16,17,18,19,20],"Procedure: Biospecimen Collection","Procedure: Bone Marrow Aspiration","Procedure: Bone Marrow Biopsy","Drug: Cytarabine","Drug: Daunorubicin Hydrochloride","Procedure: Echocardiography Test","Drug: Gemtuzumab Ozogamicin","Procedure: Multigated Acquisition Scan",{"label":22,"type":10,"description":23,"interventionNames":24},"Regimen 2 (Venetoclax, 7+3)","Patients receive venetoclax orally (PO) once daily (QD) on days 1-11, cytarabine IV, continuously, on days 2-8 and daunorubicin IV on days 2-4 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation\u002Fpost-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.",[13,14,15,16,17,18,20,25],"Drug: Venetoclax",[27,37,42,49,87,106,113,124,142],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"PROCEDURE","Biospecimen Collection","Undergo optional buccal cell collection and\u002For blood sample collection",[9,22],[33,34,35,36],"Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection",{"type":28,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Bone Marrow Aspiration","Undergo bone marrow aspiration",[9,22],null,{"type":28,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Bone Marrow Biopsy","Undergo bone marrow biopsy",[9,22],[47,48],"Biopsy of Bone Marrow","Biopsy, Bone Marrow",{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"DRUG","Cytarabine","Given IV",[9,22],[55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86],".beta.-Cytosine arabinoside","1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone","1-.beta.-D-Arabinofuranosylcytosine","1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone","1-Beta-D-arabinofuranosylcytosine","1.beta.-D-Arabinofuranosylcytosine","2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-","2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-","Alexan","Ara-C","ARA-cell","Arabine","Arabinofuranosylcytosine","Arabinosylcytosine","Aracytidine","Aracytin","Aracytine","Beta-Cytosine Arabinoside","CHX-3311","Cytarabinum","Cytarbel","Cytosar","Cytosine Arabinoside","Cytosine-.beta.-arabinoside","Cytosine-beta-arabinoside","Erpalfa","Starasid","Tarabine PFS","U 19920","U-19920","Udicil","WR-28453",{"type":50,"name":88,"description":52,"armGroupLabels":89,"otherNames":90},"Daunorubicin Hydrochloride",[9,22],[91,92,93,94,95,96,97,98,99,100,101,102,103,104,105],"Cerubidin","Cerubidine","Cloridrato de Daunorubicina","Daunoblastin","Daunoblastina","Daunoblastine","Daunomycin Hydrochloride","Daunomycin, hydrochloride","Daunorubicin.HCl","Daunorubicini Hydrochloridum","FI-6339","Ondena","RP-13057","Rubidomycin Hydrochloride","Rubilem",{"type":28,"name":107,"description":108,"armGroupLabels":109,"otherNames":110},"Echocardiography Test","Undergo echocardiography",[9,22],[111,112],"EC","Echocardiography",{"type":50,"name":114,"description":52,"armGroupLabels":115,"otherNames":116},"Gemtuzumab Ozogamicin",[9],[117,118,119,120,121,122,123],"Calicheamicin-Conjugated Humanized Anti-CD33 Monoclonal Antibody","CDP-771","CMA-676","gemtuzumab","hP67.6-Calicheamicin","Mylotarg","WAY-CMA-676",{"type":28,"name":125,"description":126,"armGroupLabels":127,"otherNames":128},"Multigated Acquisition Scan","Undergo MUGA scan",[9,22],[129,130,131,132,133,134,135,136,137,138,139,140,141],"Blood Pool Scan","Equilibrium Radionuclide Angiography","Gated Blood Pool Imaging","Gated Heart Pool Scan","MUGA","MUGA Scan","Multi-Gated Acquisition Scan","Radionuclide Ventriculogram Scan","Radionuclide Ventriculography","RNV Scan","RNVG","SYMA Scanning","Synchronized Multigated Acquisition Scanning",{"type":50,"name":143,"description":144,"armGroupLabels":145,"otherNames":146},"Venetoclax","Given PO",[22],[147,148,149,150,151,152,153,154,155,156],"ABT 199","ABT-0199","ABT-199","ABT199","GDC 0199","GDC-0199","GDC0199","RG7601","Venclexta","Venclyxto",[158],{"name":159,"affiliation":160,"role":161},"Celalettin Ustun","Alliance for Clinical Trials in Oncology","PRINCIPAL_INVESTIGATOR",[163,184,195,211,223,235,247,259,271,287,299,311,323,335,351,363,378,391,403],{"facility":164,"status":165,"city":166,"state":167,"zip":168,"country":169,"countryCode":170,"cosmosGeoPoint":171,"geoPoint":176,"contacts":177},"The James Graham Brown Cancer Center at University of Louisville","RECRUITING","Louisville","Kentucky","40202","United States","US",{"type":172,"coordinates":173},"Point",[174,175],-85.75941,38.25424,{"lat":175,"lon":174},[178,182],{"name":179,"role":180,"phone":181,"phoneExt":41,"email":41},"Site Public Contact","CONTACT","502-562-3429",{"name":183,"role":161,"phone":41,"phoneExt":41,"email":41},"Mohamed M. Hegazi",{"facility":185,"status":165,"city":166,"state":167,"zip":186,"country":169,"countryCode":170,"cosmosGeoPoint":187,"geoPoint":189,"contacts":190},"UofL Health Medical Center Northeast","40245",{"type":172,"coordinates":188},[174,175],{"lat":175,"lon":174},[191,194],{"name":179,"role":180,"phone":192,"phoneExt":41,"email":193},"502-852-2755","ctoinfo@louisville.edu",{"name":183,"role":161,"phone":41,"phoneExt":41,"email":41},{"facility":196,"status":165,"city":197,"state":198,"zip":199,"country":169,"countryCode":170,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"Trinity Health IHA Medical Group Hematology Oncology - Brighton","Brighton","Michigan","48114",{"type":172,"coordinates":201},[202,203],-83.78022,42.52948,{"lat":203,"lon":202},[206,209],{"name":179,"role":180,"phone":207,"phoneExt":41,"email":208},"734-712-7251","MCRCwebsitecontactform@stjoeshealth.org",{"name":210,"role":161,"phone":41,"phoneExt":41,"email":41},"Tareq Al baghdadi",{"facility":212,"status":165,"city":213,"state":198,"zip":214,"country":169,"countryCode":170,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"Trinity Health IHA Medical Group Hematology Oncology - Canton","Canton","48188",{"type":172,"coordinates":216},[217,218],-83.48216,42.30865,{"lat":218,"lon":217},[221,222],{"name":179,"role":180,"phone":207,"phoneExt":41,"email":208},{"name":210,"role":161,"phone":41,"phoneExt":41,"email":41},{"facility":224,"status":165,"city":225,"state":198,"zip":226,"country":169,"countryCode":170,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital","Chelsea","48118",{"type":172,"coordinates":228},[229,230],-84.02181,42.31807,{"lat":230,"lon":229},[233,234],{"name":179,"role":180,"phone":207,"phoneExt":41,"email":208},{"name":210,"role":161,"phone":41,"phoneExt":41,"email":41},{"facility":236,"status":165,"city":237,"state":198,"zip":238,"country":169,"countryCode":170,"cosmosGeoPoint":239,"geoPoint":243,"contacts":244},"Trinity Health Saint Mary Mercy Livonia Hospital","Livonia","48154",{"type":172,"coordinates":240},[241,242],-83.35271,42.36837,{"lat":242,"lon":241},[245,246],{"name":179,"role":180,"phone":207,"phoneExt":41,"email":208},{"name":210,"role":161,"phone":41,"phoneExt":41,"email":41},{"facility":248,"status":165,"city":249,"state":198,"zip":250,"country":169,"countryCode":170,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"Trinity Health Saint Joseph Mercy Oakland Hospital","Pontiac","48341",{"type":172,"coordinates":252},[253,254],-83.29105,42.63892,{"lat":254,"lon":253},[257,258],{"name":179,"role":180,"phone":207,"phoneExt":41,"email":208},{"name":210,"role":161,"phone":41,"phoneExt":41,"email":41},{"facility":260,"status":165,"city":261,"state":198,"zip":262,"country":169,"countryCode":170,"cosmosGeoPoint":263,"geoPoint":267,"contacts":268},"Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus","Ypsilanti","48197",{"type":172,"coordinates":264},[265,266],-83.61299,42.24115,{"lat":266,"lon":265},[269,270],{"name":179,"role":180,"phone":207,"phoneExt":41,"email":208},{"name":210,"role":161,"phone":41,"phoneExt":41,"email":41},{"facility":272,"status":165,"city":273,"state":274,"zip":275,"country":169,"countryCode":170,"cosmosGeoPoint":276,"geoPoint":280,"contacts":281},"Baptist Memorial Hospital and Cancer Center-Golden Triangle","Columbus","Mississippi","39705",{"type":172,"coordinates":277},[278,279],-88.42726,33.49567,{"lat":279,"lon":278},[282,285],{"name":179,"role":180,"phone":283,"phoneExt":41,"email":284},"901-226-1366","BCCclintrials@bmhcc.org",{"name":286,"role":161,"phone":41,"phoneExt":41,"email":41},"Salil Goorha",{"facility":288,"status":165,"city":289,"state":274,"zip":290,"country":169,"countryCode":170,"cosmosGeoPoint":291,"geoPoint":295,"contacts":296},"Baptist Cancer Center-Grenada","Grenada","38901",{"type":172,"coordinates":292},[293,294],-89.80842,33.769,{"lat":294,"lon":293},[297,298],{"name":179,"role":180,"phone":283,"phoneExt":41,"email":284},{"name":286,"role":161,"phone":41,"phoneExt":41,"email":41},{"facility":300,"status":165,"city":301,"state":274,"zip":302,"country":169,"countryCode":170,"cosmosGeoPoint":303,"geoPoint":307,"contacts":308},"Baptist Memorial Hospital and Cancer Center-Union County","New Albany","38652",{"type":172,"coordinates":304},[305,306],-89.00784,34.49427,{"lat":306,"lon":305},[309,310],{"name":179,"role":180,"phone":283,"phoneExt":41,"email":284},{"name":286,"role":161,"phone":41,"phoneExt":41,"email":41},{"facility":312,"status":165,"city":313,"state":274,"zip":314,"country":169,"countryCode":170,"cosmosGeoPoint":315,"geoPoint":319,"contacts":320},"Baptist Memorial Hospital and Cancer Center-Oxford","Oxford","38655",{"type":172,"coordinates":316},[317,318],-89.51925,34.3665,{"lat":318,"lon":317},[321,322],{"name":179,"role":180,"phone":283,"phoneExt":41,"email":284},{"name":286,"role":161,"phone":41,"phoneExt":41,"email":41},{"facility":324,"status":165,"city":325,"state":274,"zip":326,"country":169,"countryCode":170,"cosmosGeoPoint":327,"geoPoint":331,"contacts":332},"Baptist Memorial Hospital and Cancer Center-Desoto","Southhaven","38671",{"type":172,"coordinates":328},[329,330],-90.12759,34.99176,{"lat":330,"lon":329},[333,334],{"name":179,"role":180,"phone":283,"phoneExt":41,"email":284},{"name":286,"role":161,"phone":41,"phoneExt":41,"email":41},{"facility":336,"status":165,"city":337,"state":338,"zip":339,"country":169,"countryCode":170,"cosmosGeoPoint":340,"geoPoint":344,"contacts":345},"Bozeman Health Deaconess Hospital","Bozeman","Montana","59715",{"type":172,"coordinates":341},[342,343],-111.03856,45.67965,{"lat":343,"lon":342},[346,349],{"name":179,"role":180,"phone":347,"phoneExt":41,"email":348},"406-969-6060","mccinfo@mtcancer.org",{"name":350,"role":161,"phone":41,"phoneExt":41,"email":41},"John M. Schallenkamp",{"facility":352,"status":165,"city":353,"state":338,"zip":354,"country":169,"countryCode":170,"cosmosGeoPoint":355,"geoPoint":359,"contacts":360},"Community Medical Center","Missoula","59804",{"type":172,"coordinates":356},[357,358],-113.994,46.87215,{"lat":358,"lon":357},[361,362],{"name":179,"role":180,"phone":347,"phoneExt":41,"email":348},{"name":350,"role":161,"phone":41,"phoneExt":41,"email":41},{"facility":364,"status":165,"city":365,"state":366,"zip":367,"country":169,"countryCode":170,"cosmosGeoPoint":368,"geoPoint":372,"contacts":373},"University of Rochester","Rochester","New York","14642",{"type":172,"coordinates":369},[370,371],-77.61556,43.15478,{"lat":371,"lon":370},[374,376],{"name":179,"role":180,"phone":375,"phoneExt":41,"email":41},"585-275-5830",{"name":377,"role":161,"phone":41,"phoneExt":41,"email":41},"Bassil Botros",{"facility":379,"status":165,"city":380,"state":381,"zip":382,"country":169,"countryCode":170,"cosmosGeoPoint":383,"geoPoint":387,"contacts":388},"Baptist Memorial Hospital and Cancer Center-Collierville","Collierville","Tennessee","38017",{"type":172,"coordinates":384},[385,386],-89.66453,35.04204,{"lat":386,"lon":385},[389,390],{"name":179,"role":180,"phone":283,"phoneExt":41,"email":284},{"name":286,"role":161,"phone":41,"phoneExt":41,"email":41},{"facility":392,"status":165,"city":393,"state":381,"zip":394,"country":169,"countryCode":170,"cosmosGeoPoint":395,"geoPoint":399,"contacts":400},"Baptist Memorial Hospital and Cancer Center-Memphis","Memphis","38120",{"type":172,"coordinates":396},[397,398],-90.04898,35.14953,{"lat":398,"lon":397},[401,402],{"name":179,"role":180,"phone":283,"phoneExt":41,"email":284},{"name":286,"role":161,"phone":41,"phoneExt":41,"email":41},{"facility":404,"status":165,"city":405,"state":406,"zip":407,"country":169,"countryCode":170,"cosmosGeoPoint":408,"geoPoint":412,"contacts":413},"Gundersen Lutheran Medical Center","La Crosse","Wisconsin","54601",{"type":172,"coordinates":409},[410,411],-91.23958,43.80136,{"lat":411,"lon":410},[414,417],{"name":179,"role":180,"phone":415,"phoneExt":41,"email":416},"608-775-2385","cancerctr@gundersenhealth.org",{"name":418,"role":161,"phone":41,"phoneExt":41,"email":41},"Michael O. Ojelabi",{"type":420,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100586633","phase-2-testing-the-addition-of-venetoclax-or-gemtuzumab-ozogamicin-go-to-usual-treatment-regimen-cytarabine-and-daunorubicin-73-for-core-binding-factor-acute-myeloid-leukemia-cbf-aml-to-improve-response-a-myelomatch-treatment-trial-100586633",false,"NCT06917911","Testing the Addition of Venetoclax or Gemtuzumab Ozogamicin (GO) to Usual Treatment Regimen (Cytarabine and Daunorubicin, \"7+3\") for Core Binding Factor Acute Myeloid Leukemia (CBF-AML) to Improve Response (A MYELOMATCH Treatment Trial)","Phase II Study of Cytarabine + Daunorubicin (7 + 3) + Gemtuzumab Ozogamicin vs. Cytarabine + Daunorubicin (7 + 3) + Venetoclax for the Treatment of Newly Diagnosed Core Binding Factor Acute Myeloid Leukemia (CBF-AML) in Younger Adults: A MyeloMATCH Substudy","Inclusion Criteria:\n\n* GENERAL MYELOMATCH CRITERIA: Patients must be registered to the Master Screening and Reassessment Protocol, MYELOMATCH, and assigned to this protocol by the MATCHBox Treatment Verification Team\n* GENERAL MYELOMATCH CRITERIA: Participants must not have received prior anti-cancer therapy for AML or myelodysplastic syndrome (MDS)\n\n  * Note: Hydroxyurea to control the white blood cell count (WBC) and cytarabine up to 1g for urgent cytoreduction is allowed.\n  * Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility\n* GENERAL MYELOMATCH CRITERIA: Participants must not receive any cytarabine-containing therapy other than up to 1g of cytarabine, which is allowed for urgent cytoreduction. Hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide is allowed\n* Diagnosis of AML with t(8;21)(q22;q22.1)\u002FRUNX1::RUNX1T1 or AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22)\u002FCBFB::MYH11. No FLT3 mutation (these patients should be considered for a FLT3-focused MYELOMATCH study)\n* Secondary CBF-AML (e.g., prior pre-leukemic hematologic malignancy or history of chemotherapy\u002Fradiation therapy) is allowed.\n* No prior AML or MDS-directed therapy except for urgent treatment of leukocytosis with leukapheresis, cytarabine, and hydroxyurea, Prior intrathecal chemotherapy for central nervous system (CNS) involvement of AML is permitted\n* Age 18-59 years\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless patient has a history of Gilbert syndrome and direct bilirubin is ≤ 1.5 x ULN)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002F alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x upper limit of normal (ULN)\n* Glomerular filtration rate (GFR) ≥ 30 mL\u002Fmin\u002F1.73m\\^2\n* Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 7 days prior to registration is required\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Participants with CNS disease are eligible for this trial and will be treated according to institutional guidelines with intrathecal chemotherapy for this aspect of their disease\n* Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* No known medical condition causing an inability to swallow oral formulations of agents","ALL","18 Years","59 Years",{"count":432,"type":433},162,"ESTIMATED","INTERVENTIONAL",[436],"PHASE2","This phase II MYELOMATCH treatment trial compares the effect of venetoclax to gemtuzumab ozogamicin, when given with cytarabine and daunorubicin (\"7+3\" regimen), for the treatment of patients with core binding factor acute myeloid leukemia (CBF-AML). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to an antitumor antibiotic drug, called ozogamicin. Gemtuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD33 receptors, and delivers ozogamicin to kill them. Chemotherapy drugs, such as cytarabine and daunorubicin work in different ways to stop the growth of cancer cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax with cytarabine and daunorubicin may have fewer side effects and be as effective or better than the combination with gemtuzumab ozogamicin in treating patients with core binding factor AML.",[439],"Core Binding Factor Acute Myeloid Leukemia","2026-07-01",{"date":442,"type":443},"2026-07-02","ACTUAL",{"date":445,"type":433},"2027-02-02",{"date":447,"type":433},"2027-11-25",{"name":5,"class":6},19]