Ignite Creation Date:
2025-12-24 @ 11:49 AM
Ignite Modification Date:
2026-01-26 @ 1:39 PM
Study NCT ID:
NCT03836261
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-27
First Post:
2019-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL
Sponsor:
Organization:
Raw JSON
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Fixed-Duration Acalabrutinib Combinations in Untreated Chronic Lymphocytic Leukemia. N Engl J Med. 2025 Feb 20;392(8):748-762. doi: 10.1056/NEJMoa2409804. Epub 2025 Feb 5.'}, {'pmid': '39563886', 'type': 'DERIVED', 'citation': "Alfaifi A, Bahashwan S, Alsaadi M, Ageel AH, Ahmed HH, Fatima K, Malhan H, Qadri I, Almehdar H. Advancements in B-Cell Non-Hodgkin's Lymphoma: From Signaling Pathways to Targeted Therapies. Adv Hematol. 2024 Nov 12;2024:5948170. doi: 10.1155/2024/5948170. eCollection 2024."}, {'pmid': '34534514', 'type': 'DERIVED', 'citation': 'Davids MS, Lampson BL, Tyekucheva S, Wang Z, Lowney JC, Pazienza S, Montegaard J, Patterson V, Weinstock M, Crombie JL, Ng SY, Kim AI, Jacobson CA, LaCasce AS, Armand P, Arnason JE, Fisher DC, Brown JR. Acalabrutinib, venetoclax, and obinutuzumab as frontline treatment for chronic lymphocytic leukaemia: a single-arm, open-label, phase 2 study. Lancet Oncol. 2021 Oct;22(10):1391-1402. doi: 10.1016/S1470-2045(21)00455-1. Epub 2021 Sep 14.'}, {'pmid': '33796237', 'type': 'DERIVED', 'citation': "Gordon MJ, Danilov AV. The evolving role of Bruton's tyrosine kinase inhibitors in chronic lymphocytic leukemia. Ther Adv Hematol. 2021 Jan 30;12:2040620721989588. doi: 10.1177/2040620721989588. eCollection 2021."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of acalabrutinib in combination with venetoclax and acalabrutinib in combination with venetoclax with and without obinutuzumab compared to chemoimmunotherapy in subjects with previously untreated CLL', 'detailedDescription': 'This randomized, global, multicenter, open-label, Phase 3 study will evaluate the efficacy and safety of AV and AVG versus chemoimmunotherapy (FCR or BR) in subjects with previously untreated CLL without del(17p) or TP53. Subjects will be randomized in a 1:1:1 ratio into 3 arms through a block stratified randomization procedure.\n\nThe study includes screening (35 days), treatment (from randomization until study drug discontinuation) and follow-up phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women ≥18 years of age.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Diagnosis of CLL that meets published diagnostic criteria (Hallek et al. 2018)\n* Active disease per IWCLL 2018 criteria that requires treatment.\n* Participants must use highly effective birth control throughout the study.\n\nExclusion Criteria:\n\n* Any prior CLL-specific therapies.\n* Detected del(17p) or TP53 mutation.\n* Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (e.g., Richter's transformation, prolymphocytic leukemia \\[PLL\\], or diffuse large B cell lymphoma \\[DLBCL\\]), or central nervous system (CNS) involvement by leukemia.\n* History of confirmed progressive multifocal leukoencephalopathy (PML).\n* Received any investigational drug within 30 days before first dose of study drug.\n* Major surgical procedure within 30 days before the first dose of study drug.\n* Significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 or 4 cardiac disease. Note: Subjects with controlled, asymptomatic atrial fibrillation are allowed to enroll on study.\n* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach, or extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.\n* Received a live virus vaccination within 28 days of first dose of study drug.\n* Known history of infection with human immunodeficiency virus (HIV).\n* Serologic status reflecting active hepatitis B or C infection.\n* History of known hypersensitivity or anaphylactic reactions to study drugs or excipients.\n* History of stroke or intracranial hemorrhage within 6 months before first dose of study drug.\n* Known bleeding disorders.\n* Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists.\n* Female participants must not be breastfeeding or pregnant.\n* Concurrent participation in another therapeutic clinical trial."}, 'identificationModule': {'nctId': 'NCT03836261', 'acronym': 'AMPLIFY', 'briefTitle': 'Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL', 'nctIdAliases': ['NCT05211856'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Acerta Pharma BV'}, 'officialTitle': "A Randomized, Multicenter, Open-Label, Phase 3 Study to Compare the Efficacy and Safety of Acalabrutinib (ACP-196) in Combination With Venetoclax With and Without Obinutuzumab Compared to Investigator's Choice of Chemoimmunotherapy in Subjects With Previously Untreated Chronic Lymphocytic Leukemia Without Del(17p) or TP53 Mutation (AMPLIFY)", 'orgStudyIdInfo': {'id': 'ACE-CL-311'}, 'secondaryIdInfos': [{'id': 'D8221C00001', 'type': 'OTHER', 'domain': 'AstraZeneca'}, {'id': '2023-509349-11-00', 'type': 'REGISTRY', 'domain': 'CTIS (EU)'}, {'id': '2018-002443-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acalabrutinib, Venetoclax', 'description': 'Acalabrutinib in combination with Venetoclax', 'interventionNames': ['Drug: Acalabrutinib', 'Drug: Venetoclax']}, {'type': 'EXPERIMENTAL', 'label': 'Acalabrutinib, Venetoclax, Obinutuzumab', 'description': 'Acalabrutinib in combination with Venetoclax with Obinutuzumab', 'interventionNames': ['Drug: Acalabrutinib', 'Drug: Venetoclax', 'Drug: Obinutuzumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chemoimmunotherapy', 'description': 'Chemoimmunotherapy\n\nFCR: Fludarabine, Cyclophosphamide and Rituximab\n\nBR: Bendamustine and Rituximab', 'interventionNames': ['Drug: Chemoimmunotherapy']}], 'interventions': [{'name': 'Acalabrutinib', 'type': 'DRUG', 'otherNames': ['Calquence (acalabrutinib)'], 'description': 'Acalabrutinib,', 'armGroupLabels': ['Acalabrutinib, Venetoclax', 'Acalabrutinib, Venetoclax, Obinutuzumab']}, {'name': 'Venetoclax', 'type': 'DRUG', 'otherNames': ['Venclyxto, Venclexta'], 'description': 'Venetoclax', 'armGroupLabels': ['Acalabrutinib, Venetoclax', 'Acalabrutinib, Venetoclax, Obinutuzumab']}, {'name': 'Chemoimmunotherapy', 'type': 'DRUG', 'description': 'fludarabine/cyclophosphamide/rituximab (FCR), bendamustine/rituximab (BR)', 'armGroupLabels': ['Chemoimmunotherapy']}, {'name': 'Obinutuzumab', 'type': 'DRUG', 'otherNames': ['Gazyva, Gazyvaro'], 'description': 'Obinutuzumab', 'armGroupLabels': ['Acalabrutinib, Venetoclax, Obinutuzumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90277', 'city': 'Redondo Beach', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.84918, 'lon': -118.38841}}, {'zip': '46804', 'city': 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