[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594842":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":49,"studyPopulation":42,"armGroups":50,"interventions":58,"overallOfficials":42,"centralContacts":73,"locations":79,"responsibleParty":357,"collaborators":359,"id":364,"slug":365,"hasResults":366,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":366,"sex":372,"minAge":373,"maxAge":374,"enrollmentInfo":375,"targetDuration":42,"studyType":378,"phases":379,"briefSummary":381,"conditions":382,"keywords":385,"overallStatus":82,"whyStopped":42,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":397},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":42},[9],{"measure":10,"description":11,"timeFrame":12},"Overall Response Rate (ORR)","ORR, defined as the proportion of participants who achieve best response of CR, CRi, nPR, or PR per iwCLL criteria as assessed by the investigator.","ORR assessed at multiple timepoints during treatment period (each cycle is 28 days). Timepoint for primary analysis is at completion of cycle 14",[14,18,22,26,30,34,38],{"measure":15,"description":16,"timeFrame":17},"Progression Free Survival (PFS)","PFS is defined as time from date of the first dose until progression per iwCLL criteria or death due to any cause in the absence of progression.","PFS will be assessed from Cycle 3 to Cycle 24 during treatment period (each cycle is 28 days)",{"measure":19,"description":20,"timeFrame":21},"Duration of Response (DoR)","DoR is defined as the time from the date of first documented response until date of documented progression per iwCLL criteria or death due to any cause.","DoR will be assessed from Cycle 3 to Cycle 24 during treatment period (each cycle is 28 days)",{"measure":23,"description":24,"timeFrame":25},"Event Free Survival (EFS)","EFS is defined as the time from date of the first dose until the first occurrence of disease progression, initiation of subsequent CLL\u002FSLL therapy, or death due to any cause.","EFS will be assessed from Cycle 3 to Cycle 24 during treatment period (each cycle is 28 days)",{"measure":27,"description":28,"timeFrame":29},"Time to Next Treatment (TTNT)","TTNT is defined as the time from date of the first dose to the initiation of subsequent CLL\u002FSLL therapy or death due to any cause","TTNT will be assessed from Cycle 3 to Cycle 24 during treatment period (each cycle is 28 days)",{"measure":31,"description":32,"timeFrame":33},"Overall Survival (OS)","OS is defined as the time from date of the first dose until the date of death due to any cause.","OS will be assessed every 3 months through the study completion, for 5 years",{"measure":35,"description":36,"timeFrame":37},"Rate of undetectable Minimal Residual Disease (uMRD)","Rate of peripheral blood (PB) uMRD, defined as proportion of participants achieving remission based on a clonoSEQ® assay result of \\\u003C1 CLL cell per 100,000 leukocytes (\\\u003C 10-5).","uMRD will be measured at 3 months after last treatment",{"measure":39,"description":40,"timeFrame":41},"Treatment-Emergent Adverse Events (safety and tolerability) of second-line (2L) treatment with Acalabrutinib and Venetoclax after relapse following 1L cBTKi + BCL2i","Safety and tolerability will be evaluated in terms of AEs\u002FSAEs, AEs leading to treatment discontinuation and deaths, and relevant clinical laboratory results.","Safety and tolerability will be evaluated throughout the study for 5 years",null,{"allocation":44,"interventionModel":45,"interventionModelDescription":42,"primaryPurpose":46,"observationalModel":42,"timePerspective":42,"maskingInfo":47},"NON_RANDOMIZED","SINGLE_GROUP","TREATMENT",{"masking":48,"maskingDescription":42,"whoMasked":42},"NONE","The purpose of this study is to explore the use of second line (2L) treatment with AV after relapse following first line (1L) cBTKi + BCL2i by assessment of ORR in participants with CLL\u002FSLL. This study will generate efficacy and safety data needed to understand outcomes associated with AV in patients who initially responded with partial remission (PR) or better for a minimum of 2 years from the end of 1L cBTKi + BCL2i combination treatment and are experiencing clinical relapse requiring further treatment. MAVRiC explores AV as second-line (2L) CLL\u002FSLL treatment after relapse on first-line (1L) cBTKi + BCL-2 by assessment of overall response rate (ORR)\n\n* The study duration for each participant will be up to 5 year.\n* The study consists of screening, treatment, and post-intervention follow-up periods.\n* Participants will be grouped into low or high risk cohorts based on disease risk determined by IGHV mutation and TP53 aberrancy.",[51],{"label":52,"type":53,"description":54,"interventionNames":55},"Acalabrutinib and Venetoclax","EXPERIMENTAL","For Cohort 1, each participant will be in the study for approximately 5 years (60 months) counting from C1D1, starting with 2 cycles of acalabrutinib lead-in treatment, followed by 12 cycles of AV combination treatment, and 4 years of follow-up.\n\nFor Cohort 2, each participant will be in the study for approximately 5 years (60 months) counting from C1D1 starting with 2 cycles of acalabrutinib lead-in treatment, followed by 22 cycles of AV combination treatment, and 3 years of follow-up.",[56,57],"Drug: Acalabrutinib","Drug: Venetoclax",[59,66],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":64},"DRUG","Acalabrutinib","Acalabrutinib is an orally available cBTKi that inhibits the activity of BTK and prevents the activation of the B-cell antigen receptor (BCR) signaling pathway.",[52],[65],"CALQUENCE®",{"type":60,"name":67,"description":68,"armGroupLabels":69,"otherNames":70},"Venetoclax","Venetoclax is an orally bioavailable inhibitor of the anti-apoptotic protein BCL-2",[52],[71,72],"Venclexta®","Venclyxto®",[74],{"name":75,"role":76,"phone":77,"phoneExt":42,"email":78},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[80,94,104,108,116,124,134,145,153,158,166,171,180,183,191,201,206,216,224,229,237,245,253,261,271,279,287,295,303,308,318,323,331,339,344,349],{"facility":81,"status":82,"city":83,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":42},"Research Site","RECRUITING","Boston","Massachusetts","02215","United States","US",{"type":89,"coordinates":90},"Point",[91,92],-71.05977,42.35843,{"lat":92,"lon":91},{"facility":81,"status":95,"city":96,"state":97,"zip":98,"country":86,"countryCode":87,"cosmosGeoPoint":99,"geoPoint":103,"contacts":42},"WITHDRAWN","Charlotte","North 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Inc.","100594842","phase-2-phase-2-study-of-disease-risk-mutation-guided-finite-acalabrutinibvenetoclax-for-relapsed-cll-post-1l-finite-cbtkibcl2i--obinutuzumab-100594842",false,"NCT07024706","Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumab","The MAVRiC Study: A Phase II Study of Disease Risk Mutation Guided Finite Duration Acalabrutinib Plus Venetoclax for Relapse in CLL\u002FSLL After First-line Finite Covalent BTKi Plus BCL2i Combination, With or Without Obinutuzumab","MAVRiC","Main Inclusion Criteria:\n\n1. Participant must be ≥ 18 years at the time of signing informed consent.\n2. Diagnosis of CLL\u002FSLL according to iwCLL guidelines 2018 (Hallek et al. 2018)\n3. Participants must have received first line treatment with fixed duration covalent BTKi plus BCL2i therapy (± obinutuzumab) with a response ≥ PR (i.e., CR, CRi, nPR, or PR) with a minimum of 2 years since the end of the prior 1L treatment.\n4. The following data must be available or at least the appropriate samples drawn\u002Facquired prior to dosing:\n\n   1. IGHV (mutated vs. unmutated)\n   2. del(17p) (present or absent)\n   3. TP53 mutation (present or absent)\n5. ECOG performance status 0, 1 or 2\n6. Adequate organ and bone marrow (BM) function.\n\nMain Exclusion Criteria:\n\n1. Any evidence of diseases that, in the investigator's opinion, makes it undesirable for patient to participate in the study.\n2. Significant cardiovascular or cerebrovascular disease.\n3. Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease).\n4. Child-Pugh B\u002FC liver cirrhosis.\n5. History of prior or current malignancy.\n6. HIV positive\n7. History of progressive multifocal leukoencephalopathy (PML).\n8. Active hepatitis B or C infection:\n9. Corticosteroid use \\> 20 mg within 1 week before the first dose of study intervention.\n10. History of hypersensitivity or anaphylaxis to study intervention(s).\n11. Requires treatment with a strong CYP3A4 inhibitor\u002Finducer.\n12. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists.\n13. Major surgical procedure within 30 days of the first dose of study intervention.","ALL","18 Years","130 Years",{"count":376,"type":377},80,"ESTIMATED","INTERVENTIONAL",[380],"PHASE2","This study will evaluate the efficacy and safety of finite-duration acalabrutinib plus venetoclax therapy in patients with relapsed CLL or SLL, and have previously responded to first line (1L) cBTKi + BCL2i therapy (± obinutuzumab) and maintained a response for at least two years post-treatment.",[383,384],"Chronic Lymphocytic Leukemia (CLL)","Small Lymphocytic Lymphoma (SLL)",[383,384,386,387,61],"Relapsed CLL","Refractory CLL","2026-07-01",{"date":390,"type":391},"2026-07-02","ACTUAL",{"date":393,"type":391},"2026-06-04",{"date":395,"type":377},"2033-03-23",{"name":5,"class":6},36]