[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593986":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":43,"centralContacts":47,"locations":56,"responsibleParty":74,"collaborators":76,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":29,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":58,"whyStopped":29,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"New York Medical College","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Low-risk ALK+ ALCL","EXPERIMENTAL","Low risk patients include any patient with FIRST RELAPSE \\> ONE YEAR from initial diagnosis of de novo ALK+ ALCL,Common histology, CD3 negative, Minimum disseminated disease (MDD) negative at de novo diagnosis (if MDD known), AND No prior exposure to vinblastine (VBL).",[13],"Drug: Vinblastine (Velban)",{"label":15,"type":10,"description":16,"interventionNames":17},"High Risk ALK+ ALCL (BV Naive)","* Any patient with RELAPSED OR PROGRESSIVE DISEASE ONE YEAR from initial diagnosis of de novo ALK+ ALCL,\n* Small cell\u002Fhistiocytic histology,\n* CD3 positive (homogeneous staining of CD3 positive T-cells)\n* Second or later relapse,\n* Induction failure during initial treatment for de novo ALK+ ALCL, OR\n* Minimal disseminated disease (MDD) positive at de novo diagnosis (if MDD known)",[13,18,19],"Drug: Brentuximab vedotin (Adcetris)","Drug: Nivolumab (Opdivo)",{"label":21,"type":10,"description":16,"interventionNames":22},"High Risk ALK+ ALCL (with prior BV)",[13,18,19],[24,30,36],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Vinblastine (Velban)","Low risk cohort patients will receive 2 cycles of Induction therapy with single-drug vinBLAStine (VBL), then undergo disease assessment. If complete remission (CR) and MRD -, LR patients will continue single-drug VBL for a total of 24 months (if absent disease progression or unacceptable toxicity).",[15,21,9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Brentuximab vedotin (Adcetris)","HR cohort patients with no previous exposure to BV will receive 2 cycles of Induction therapy with BV and NIVO \\[BV + NIVO\\] one every 21 days, then undergo disease assessment. Patients in CR will proceed with consolidation with RTC allogeneic SCT (SCT)\\*. If patient has any response other than CR and MRD-, they will receive 2 cycles of BV, VBL, and NIVO \\[BV + VBL + NIVO\\] once every 21 days",[15,21],[35],"Nivolumab",{"type":25,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Nivolumab (Opdivo)","High risk cohort patients with previous exposure to Brentuximab vedotin (BV) will receive 2 cycles of Induction therapy with VBL and NIVO \\[VBL + NIVO\\] on day 1 and 15, then undergo disease assessment. If response is not CR, or patient has PR\u002FSD\u002FPD, patient will receive \\[BV+VBL+NIVO\\] and subsequent therapy as defined for the HR2 cohort.",[15,21],[41,42],"brentuximab vedodin","Vinblastine",[44],{"name":45,"affiliation":5,"role":46},"Mitchell S Cairo, MD","PRINCIPAL_INVESTIGATOR",[48,52],{"name":45,"role":49,"phone":50,"phoneExt":29,"email":51},"CONTACT","914-594-2150","mitchell_cairo@nymc.edu",{"name":53,"role":49,"phone":54,"phoneExt":29,"email":55},"Lauren Harrison, RN, MSN","617-285-2844","lauren_harrison@nymc.edu",[57],{"facility":5,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"RECRUITING","Valhalla","New York","10595","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-73.77513,41.07482,{"lat":68,"lon":67},[71,73],{"name":53,"role":49,"phone":72,"phoneExt":29,"email":55},"617-285-7844",{"name":45,"role":49,"phone":50,"phoneExt":29,"email":51},{"type":75,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[77,79,81,83,85,87,89,91,93,95],{"name":78,"class":6},"University of Alabama at Birmingham",{"name":80,"class":6},"Helen DeVos Children's Hospital",{"name":82,"class":6},"Nationwide Children's Hospital",{"name":84,"class":6},"Memorial Sloan Kettering Cancer Center",{"name":86,"class":6},"University of Utah",{"name":88,"class":6},"Ohio State University",{"name":90,"class":6},"University of North Carolina",{"name":92,"class":6},"Children's Hospital of Philadelphia",{"name":94,"class":6},"Medical College of Wisconsin",{"name":96,"class":6},"Children's Hospital of Orange County","100593986","phase-2-chemoimmunotherapy-for-alk-relapsedrefractory-alcl-100593986",false,"NCT07013565","Chemoimmunotherapy for ALK+ Relapsed\u002FRefractory ALCL","NYMC623: A Comprehensive Risk-adapted Chemommunotherapy Protocol of Emerging Immunotherapies for Relapsed\u002FRefractory Alk+ Anaplastic Large Cell Lymphoma (ACCELERATE)","ACCELERATE","Inclusion Criteria:\n\n* Patients must weigh ≥10 kilograms at the time of study enrollment.\n* Patients with relapsed or refractory histologically or cytologically proven ALK-positive anaplastic large cell lymphoma meeting Low or High Risk Criteria:\n\nLow Risk Cohort (LR cohort):\n\n* Any patient with FIRST RELAPSE \\> ONE YEAR from initial diagnosis of de novo ALK+ ALCL,\n* Common histology,\n* CD3 negative, AND\n* No prior exposure to vinblastine (VBL).\n\nHigh-Risk Cohort (HR cohort):\n\n* Any patient with RELAPSED OR PROGRESSIVE DISEASE less than ONE YEAR from initial diagnosis of de novo ALK+ ALCL,\n* Small cell\u002Fhistiocytic histology,\n* CD3 positive (homogeneous staining of CD3 positive T-cells)\n* Patients must have adequate organ function.\n* Patients must have performance status 60 or above.\n\nExclusion Criteria:\n\n* ALK-NEGATIVE anaplastic large cell lymphoma.\n* Patients with active leptomeningeal disease (lymphoma cells in CSF).\n* Previous treatment with vinblastine (only in patients in the LR cohort).\n* Female patients who are pregnant. Pregnancy tests must be obtained in girls who are post menarche.\n* Lactating females unless they have agreed not to breastfeed their infants.\n* Patients with Down syndrome.\n* Any patient with uncontrolled infection prior to study entry.\n* Any patient known to have primary or acquired immunodeficiency and\u002For prior solid organ transplant.","ALL","1 Year","39 Years",{"count":109,"type":110},20,"ESTIMATED","INTERVENTIONAL",[113],"PHASE2","Children, adolescents, and young adults (CAYA) with relapsed\u002Frefractory (R\u002FR) high-risk ALK+ Anaplastic Large Cell Lymphoma (ALCL) have a low incidence of overall survival. This clinical trial will investigate if a new FDA approved medication called Nivolumab (NIVO) (which is a checkpoint blockade immunotherapy) combined with chemotherapy based on the patients risk status to get the patient into the best response possible. Then patients will receive lower doses of chemoimmunotherapy and allogeneic stem cell transplantation (stem cells from another person). The investigators this this new treatment will improve survival rates in this high-risk population of patients.",[116],"Anaplastic Large Cell Lymphoma, ALK-Positive",[118,119],"ALCL","Relapsed ALCL","2026-05-18",{"date":122,"type":123},"2026-05-20","ACTUAL",{"date":125,"type":123},"2025-08-07",{"date":127,"type":110},"2030-07-01",{"name":5,"class":6},1]