Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLL: primary analysis of the CAPTIVATE FD cohort
CAPTIVATE (NCT02910583) is an international phase 2 study in patients aged <= 70 years with previously untreated chronic lymphocytic leukemia (CLL). Results from the cohort investigating fixed-duration (FD) treatment with ibrutinib plus venetoclax are reported. Patients received 3 cycles of ibrut...
| Autores: | , , , , , , , , , , , , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2022 |
| País: | España |
| Institución: | Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau) |
| Repositorio: | r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau |
| OAI Identifier: | oai:iibsantpau.fundanetsuite.com:p11210 |
| Acceso en línea: | https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=11210 https://www.scopus.com/inward/record.uri?eid=2-s2.0-85127788631&doi=10.1182%2fblood.2021014488&partnerID=40&md5=c5a37acd7ccb9792dd0662c2feee99a0 |
| Access Level: | acceso abierto |
| Palabra clave: | acalabrutinib antacid agent anticoagulant agent antihypertensive agent antithrombocytic agent calcium creatinine hemoglobin ibrutinib immunoglobulin heavy chain potassium protein bcl 2 protein p53 proton pump inhibitor rasburicase uric acid venetoclax adenine antineoplastic agent fused heterocyclic rings piperidine derivative sulfonamide adult aged arthralgia Article atrial fibrillation bone marrow metastasis brain hemorrhage brain infarction calcium blood level cancer combination chemotherapy cancer growth cancer size cancer survival chromosome 11q chromosome 17p chromosome deletion chronic lymphatic leukemia cohort analysis creatinine blood level cytoreductive surgery diarrhea disease severity drug dose increase drug dose reduction drug efficacy drug safety febrile neutropenia female follow up gene mutation heart arrest hemoglobin blood level human hypertension incidence infection lymph node metastasis |
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Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLL: primary analysis of the CAPTIVATE FD cohortTam, CSAllan, JNSiddiqi, TKipps, TJJacobs, ROpat, SBarr, PMTedeschi, ATrentin, LBannerji, RJackson, SKuss, BJMoreno, CSzafer-Glusman, ERussell, KZhou, CNinomoto, JDean, JPWierda, WGGhia, Pacalabrutinibantacid agentanticoagulant agentantihypertensive agentantithrombocytic agentcalciumcreatininehemoglobinibrutinibimmunoglobulin heavy chainpotassiumprotein bcl 2protein p53proton pump inhibitorrasburicaseuric acidvenetoclaxadenineantineoplastic agentfused heterocyclic ringsibrutinibpiperidine derivativesulfonamidevenetoclaxadultagedarthralgiaArticleatrial fibrillationbone marrow metastasisbrain hemorrhagebrain infarctioncalcium blood levelcancer combination chemotherapycancer growthcancer sizecancer survivalchromosome 11qchromosome 17pchromosome deletionchronic lymphatic leukemiacohort analysiscreatinine blood levelcytoreductive surgerydiarrheadisease severitydrug dose increasedrug dose reductiondrug efficacydrug safetyfebrile neutropeniafemalefollow upgene mutationheart arresthemoglobin blood levelhumanhypertensionincidenceinfectionlymph node metastasisCAPTIVATE (NCT02910583) is an international phase 2 study in patients aged <= 70 years with previously untreated chronic lymphocytic leukemia (CLL). Results from the cohort investigating fixed-duration (FD) treatment with ibrutinib plus venetoclax are reported. Patients received 3 cycles of ibrutinib lead-in then 12 cycles of ibrutinib plus venetoclax (oral ibrutinib [420 mg/d]; oral venetoclax [5-week ramp-up to 400 mg/d]). The primary endpoint was complete response (CR) rate. Hypothesis testing was performed for patients without del(17p) with prespecified analyses in all treated patients. Secondary endpoints included undetectable minimal residual disease (uMRD) rates, progression-free survival (PFS), overall survival (OS), and safety. Of the 159 patients enrolled and treated, 136 were without del(17p). The median time on study was 27.9 months, and 92% of patients completed all planned treatment. The primary endpoint was met, with a CR rate of 56% (95% confidence interval [CI], 48-64) in patients without del(17p), significantly higher than the prespecified 37% minimum rate (P < .0001). In the all-treated population, CR rate was 55% (95% CI, 48-63); best uMRD rates were 77% (peripheral blood [PB]) and 60% (bone marrow [BM]); 24-month PFS and OS rates were 95% and 98%, respectively. At baseline, 21% of patients were in the high tumor burden category for tumor lysis syndrome (TLS) risk; after ibrutinib lead-in, only 1% remained in this category. The most common grade >= 3 adverse events (AEs) were neutropenia (33%) and hypertension (6%). First-line ibrutinib plus venetoclax represents the first all-oral, once-daily, chemotherapy-free FD regimen for patients with CLL. FD ibrutinib plus venetoclax achieved deep, durable responses and promising PFS, including in patients with high-risk features.AMER SOC HEMATOLOGY2022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=11210https://www.scopus.com/inward/record.uri?eid=2-s2.0-85127788631&doi=10.1182%2fblood.2021014488&partnerID=40&md5=c5a37acd7ccb9792dd0662c2feee99a0BLOODISSN: 00064971ISSNe: 15280020reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pauinstname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)Inglésinfo:eu-repo/semantics/openAccessoai:iibsantpau.fundanetsuite.com:p112102026-06-14T12:41:47Z |
| dc.title.none.fl_str_mv |
Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLL: primary analysis of the CAPTIVATE FD cohort |
| title |
Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLL: primary analysis of the CAPTIVATE FD cohort |
| spellingShingle |
Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLL: primary analysis of the CAPTIVATE FD cohort Tam, CS acalabrutinib antacid agent anticoagulant agent antihypertensive agent antithrombocytic agent calcium creatinine hemoglobin ibrutinib immunoglobulin heavy chain potassium protein bcl 2 protein p53 proton pump inhibitor rasburicase uric acid venetoclax adenine antineoplastic agent fused heterocyclic rings ibrutinib piperidine derivative sulfonamide venetoclax adult aged arthralgia Article atrial fibrillation bone marrow metastasis brain hemorrhage brain infarction calcium blood level cancer combination chemotherapy cancer growth cancer size cancer survival chromosome 11q chromosome 17p chromosome deletion chronic lymphatic leukemia cohort analysis creatinine blood level cytoreductive surgery diarrhea disease severity drug dose increase drug dose reduction drug efficacy drug safety febrile neutropenia female follow up gene mutation heart arrest hemoglobin blood level human hypertension incidence infection lymph node metastasis |
| title_short |
Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLL: primary analysis of the CAPTIVATE FD cohort |
| title_full |
Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLL: primary analysis of the CAPTIVATE FD cohort |
| title_fullStr |
Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLL: primary analysis of the CAPTIVATE FD cohort |
| title_full_unstemmed |
Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLL: primary analysis of the CAPTIVATE FD cohort |
| title_sort |
Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLL: primary analysis of the CAPTIVATE FD cohort |
| dc.creator.none.fl_str_mv |
Tam, CS Allan, JN Siddiqi, T Kipps, TJ Jacobs, R Opat, S Barr, PM Tedeschi, A Trentin, L Bannerji, R Jackson, S Kuss, BJ Moreno, C Szafer-Glusman, E Russell, K Zhou, C Ninomoto, J Dean, JP Wierda, WG Ghia, P |
| author |
Tam, CS |
| author_facet |
Tam, CS Allan, JN Siddiqi, T Kipps, TJ Jacobs, R Opat, S Barr, PM Tedeschi, A Trentin, L Bannerji, R Jackson, S Kuss, BJ Moreno, C Szafer-Glusman, E Russell, K Zhou, C Ninomoto, J Dean, JP Wierda, WG Ghia, P |
| author_role |
author |
| author2 |
Allan, JN Siddiqi, T Kipps, TJ Jacobs, R Opat, S Barr, PM Tedeschi, A Trentin, L Bannerji, R Jackson, S Kuss, BJ Moreno, C Szafer-Glusman, E Russell, K Zhou, C Ninomoto, J Dean, JP Wierda, WG Ghia, P |
| author2_role |
author author author author author author author author author author author author author author author author author author author |
| dc.subject.none.fl_str_mv |
acalabrutinib antacid agent anticoagulant agent antihypertensive agent antithrombocytic agent calcium creatinine hemoglobin ibrutinib immunoglobulin heavy chain potassium protein bcl 2 protein p53 proton pump inhibitor rasburicase uric acid venetoclax adenine antineoplastic agent fused heterocyclic rings ibrutinib piperidine derivative sulfonamide venetoclax adult aged arthralgia Article atrial fibrillation bone marrow metastasis brain hemorrhage brain infarction calcium blood level cancer combination chemotherapy cancer growth cancer size cancer survival chromosome 11q chromosome 17p chromosome deletion chronic lymphatic leukemia cohort analysis creatinine blood level cytoreductive surgery diarrhea disease severity drug dose increase drug dose reduction drug efficacy drug safety febrile neutropenia female follow up gene mutation heart arrest hemoglobin blood level human hypertension incidence infection lymph node metastasis |
| topic |
acalabrutinib antacid agent anticoagulant agent antihypertensive agent antithrombocytic agent calcium creatinine hemoglobin ibrutinib immunoglobulin heavy chain potassium protein bcl 2 protein p53 proton pump inhibitor rasburicase uric acid venetoclax adenine antineoplastic agent fused heterocyclic rings ibrutinib piperidine derivative sulfonamide venetoclax adult aged arthralgia Article atrial fibrillation bone marrow metastasis brain hemorrhage brain infarction calcium blood level cancer combination chemotherapy cancer growth cancer size cancer survival chromosome 11q chromosome 17p chromosome deletion chronic lymphatic leukemia cohort analysis creatinine blood level cytoreductive surgery diarrhea disease severity drug dose increase drug dose reduction drug efficacy drug safety febrile neutropenia female follow up gene mutation heart arrest hemoglobin blood level human hypertension incidence infection lymph node metastasis |
| description |
CAPTIVATE (NCT02910583) is an international phase 2 study in patients aged <= 70 years with previously untreated chronic lymphocytic leukemia (CLL). Results from the cohort investigating fixed-duration (FD) treatment with ibrutinib plus venetoclax are reported. Patients received 3 cycles of ibrutinib lead-in then 12 cycles of ibrutinib plus venetoclax (oral ibrutinib [420 mg/d]; oral venetoclax [5-week ramp-up to 400 mg/d]). The primary endpoint was complete response (CR) rate. Hypothesis testing was performed for patients without del(17p) with prespecified analyses in all treated patients. Secondary endpoints included undetectable minimal residual disease (uMRD) rates, progression-free survival (PFS), overall survival (OS), and safety. Of the 159 patients enrolled and treated, 136 were without del(17p). The median time on study was 27.9 months, and 92% of patients completed all planned treatment. The primary endpoint was met, with a CR rate of 56% (95% confidence interval [CI], 48-64) in patients without del(17p), significantly higher than the prespecified 37% minimum rate (P < .0001). In the all-treated population, CR rate was 55% (95% CI, 48-63); best uMRD rates were 77% (peripheral blood [PB]) and 60% (bone marrow [BM]); 24-month PFS and OS rates were 95% and 98%, respectively. At baseline, 21% of patients were in the high tumor burden category for tumor lysis syndrome (TLS) risk; after ibrutinib lead-in, only 1% remained in this category. The most common grade >= 3 adverse events (AEs) were neutropenia (33%) and hypertension (6%). First-line ibrutinib plus venetoclax represents the first all-oral, once-daily, chemotherapy-free FD regimen for patients with CLL. FD ibrutinib plus venetoclax achieved deep, durable responses and promising PFS, including in patients with high-risk features. |
| publishDate |
2022 |
| dc.date.none.fl_str_mv |
2022 |
| dc.type.none.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
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article |
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publishedVersion |
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https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=11210 https://www.scopus.com/inward/record.uri?eid=2-s2.0-85127788631&doi=10.1182%2fblood.2021014488&partnerID=40&md5=c5a37acd7ccb9792dd0662c2feee99a0 |
| url |
https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=11210 https://www.scopus.com/inward/record.uri?eid=2-s2.0-85127788631&doi=10.1182%2fblood.2021014488&partnerID=40&md5=c5a37acd7ccb9792dd0662c2feee99a0 |
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Inglés |
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Inglés |
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info:eu-repo/semantics/openAccess |
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openAccess |
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AMER SOC HEMATOLOGY |
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AMER SOC HEMATOLOGY |
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BLOOD ISSN: 00064971 ISSNe: 15280020 reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau instname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau) |
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Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau) |
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r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau |
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r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau |
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