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Um estudo de pirtobrutinibe (LOXO-305) versus bendamustina mais rituximabe (BR) em pacientes não tratados com leucemia linfocítica crônica (LLC)/linfoma linfocítico de pequenos (SLL) (BRUIN-CLL-313)

24 de setembro de 2026 atualizado por: Loxo Oncology, Inc.

Um estudo randomizado, aberto de fase 3 de pirtobrutinibe (LOXO-305) versus bendamustina mais rituximabe em pacientes não tratados com leucemia linfocítica crônica/linfoma linfocítico pequeno

The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

282

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Austrália
    • New South Wales
      • Liverpool, New South Wales, Austrália, 2170
        • Liverpool Hospital
      • Wentworthville, New South Wales, Austrália, 2145
        • Westmead Hospital
    • Victoria
      • Frankston, Victoria, Austrália, 3199
        • Peninsula Private Hospital
  • Brasil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasil, 90035-903
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brasil, 90050-170
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brasil, 90110270
        • Centro Gaucho Integrado - Mae de Deus Center
    • São Paulo
      • Campinas, São Paulo, Brasil, 13083-878
        • Hemocentro Unicamp
      • Jaú, São Paulo, Brasil, 17210120
        • Fundação Doutor Amaral Carvalho
  • Bulgária
      • Plovdiv, Bulgária, 4000
        • UMHAT "Sveti Georgi" EAD
      • Sofia, Bulgária, 1431
        • UMHAT 'Sv. Ivan Rilski', EAD
      • Sofia, Bulgária, 1797
        • "SHATHD" EAD, Sofia
      • Stara Zagora, Bulgária, 6003
        • UMHAT - Prof. Dr. Stoyan Kirkovich" AD
  • China
      • Beijing, China, 100730
        • Beijing Hospital
      • Chongqing, China, 400030
        • Chongqing Cancer Hospital
      • Zhengzhou, China, 450008
        • Henan Cancer Hospital
    • Anhui
      • Hefei, Anhui, China, 233004
        • Anhui Provincial Cancer Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital
      • Beijing, Beijing Municipality, China, 100034
        • Peking University First Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • The First Affiliated Hospital of Guangzhou Medical University
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital Central South University
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 010050
        • The Affiliated Hospital of Inner Mongolia Medical University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University
    • Liaoning
      • Shenyany, Liaoning, China, 110022
        • Shengjing Hospital of China Medical University
    • Nanjing
      • Nanjing, Nanjing, China, 210029
        • Jiangsu Province Hospital
    • Shanghai Municipality
      • Changning District, Shanghai Municipality, China, 200050
        • Shanghai Tongren Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Sichuan University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Tianjin Medical University Cancer Institute and Hospital
      • Tianjin, Tianjin Municipality, China, 300020
        • Institute of hematology&blood disease hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 311100
        • The First People's Hospital of Hangzhou Linping District
  • Coréia do Sul
      • Busan, Coréia do Sul, 47392
        • Inje Univ Busan Paik Hospital
    • Incheon-gwangyeoksi [Incheon]
      • Namdong-gu, Incheon-gwangyeoksi [Incheon], Coréia do Sul, 21565
        • Gachon University Gil Medical Center
    • Seoul
      • Seocho-Gu, Seoul, Coréia do Sul, 06591
        • The Catholic University of Korea-Seoul St. Mary's Hospital
    • Seoul, Korea
      • Seoul, Seoul, Korea, Coréia do Sul, 03080
        • Seoul National University Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Coréia do Sul, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Seoul-teukbyeolsi [Seoul], Coréia do Sul, 06351
        • Samsung Medical Center
  • Espanha
      • Barcelona, Espanha, 08041
        • Hospital de la Santa Creu i Sant Pau
      • Madrid, Espanha, 28040
        • Hospital Universitario Fundación Jiménez Díaz
      • Seville, Espanha, 41013
        • Hospital Universitario Virgen del Rocío
      • Seville, Espanha, 41014
        • Hospital Universitario Virgen de Valme
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Espanha, 28050
        • Hospital Universitario HM Sanchinarro
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Espanha, 33011
        • Hospital Universitario Central de Asturias
  • Estados Unidos
    • California
      • Los Angeles, California, Estados Unidos, 90027
        • California Research Institute
      • Whittier, California, Estados Unidos, 90603
        • Innovative Clinical Research Institute
    • Florida
      • Coral Springs, Florida, Estados Unidos, 33065
        • Oncology-Hematology Associates of West Broward
    • New Jersey
      • Brick, New Jersey, Estados Unidos, 08724
        • New Jersey Center for Cancer Research
    • New York
      • Westbury, New York, Estados Unidos, 11590
        • Clinical Research Alliance, Inc.
  • França
      • Le Mans, França, 72000
        • Hospitalier Le Mans
  • Hungria
      • Debrecen, Hungria, 4032
        • Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
      • Nyíregyháza, Hungria, 4400
        • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
      • Székesfehérvár, Hungria, 8000
        • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Itália
      • Bergamo, Itália, 24127
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
      • Brescia, Itália, 25123
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
      • Meldola, Itália, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
      • Milan, Itália, 20122
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
      • Milan, Itália, 20162
        • ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C
      • Monza, Itália, 20900
        • Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
      • Novara, Itália, 28100
        • Azienda Ospedale Maggiore Della Carita
      • Perugia, Itália, 06132
        • Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich)
      • Ravenna, Itália, 48020
        • Ospedale Santa Maria delle Croci
      • Terni, Itália, 05100
        • Azienda Ospedaliera Santa Maria Terni
      • Trieste, Itália, 34125
        • Azienda sanitaria integrata università di Trieste
    • Potenza
      • Rionero in Vulture, Potenza, Itália, 85028
        • Irccs Crob
  • Japão
      • Aomori, Japão, 030-8553
        • Aomori Prefectural Centeral Hospital
      • Fukoka-ken, Japão, 806 8501
        • JCHO Kyushu Hospital
    • Aichi-ken
      • Nagoya, Aichi-ken, Japão, 467-8602
        • Nagoya City University Hospital
    • Chiba
      • Chiba, Chiba, Japão, 260-8717
        • Chiba Cancer Center
    • Fukui
      • Yoshida-Gun, Fukui, Japão, 910-1193
        • Fukui Medical University Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japão, 0030006
        • Hokuyukai Sapporo Hokuyu Hospital
    • Kochi
      • Nankoku, Kochi, Japão, 783-8505
        • Kochi Medical School Hospital
    • Miyagi
      • Sendai, Miyagi, Japão, 980-8574
        • Tohoku University Hospital
      • Sendai, Miyagi, Japão, 9838520
        • NHO Sendai Medical Center
    • Saitama
      • Koshigaya, Saitama, Japão, 343 8555
        • Dokkyo Medical University - Koshigaya Hospital
    • Yamanshi
      • Chūō, Yamanshi, Japão, 409-3821
        • University of Yamanashi Hospital
  • Nova Zelândia
      • Christchurch, Nova Zelândia, 8011
        • Christchurch Hospital
      • Papatoetoe, Nova Zelândia, 2025
        • Middlemore Clinical Trials
    • Auckland
      • Takapuna, Auckland, Nova Zelândia, 0622
        • North Shore Hospital, Haematology Research
    • Bay of Plenty
      • Tauranga, Bay of Plenty, Nova Zelândia, 3112
        • Tauranga Hospital
  • Polônia
      • Biała Podlaska, Polônia, 21500
        • KO-MED Centra Kliniczne
      • Bydgoszcz, Polônia, 85-168
        • Szpital Uniwersytecki nr 1 im. Antoniego Jurasza
      • Katowice, Polônia, 40519
        • Pratia Onkologia Katowice
      • Krakow, Polônia, 30727
        • Pratia MCM Krakow
      • Lublin, Polônia, 20-090
        • Centrum Onkologii Ziemi Lubelskiej
      • Torun, Polônia, 87-100
        • Nasz Lekarz Osrodek Badan Klinicznych
      • Warsaw, Polônia, 02781
        • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Cuire - Państwowy Instytut Badawczy
      • Wroclaw, Polônia, 50-367
        • Uniwersytecki Szpital Kliniczny Klinika
    • Legnica
      • Iwaszkiewicza 5, Legnica, Polônia, 59-220
        • Wojewodzki Szpital Specjalistyczny
    • Lubelskie V
      • Lublin, Lubelskie V, Polônia, 20081
        • Klinika Hematoonkologii i Transplantacji Szpiku SPSK1 Lublin
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Polônia, 80214
        • Uniwersyteckie Centrum Kliniczne
    • Poznan
      • Skorzewo, Poznan, Polônia, 60 185
        • Centrum Medyczne Pratia Poznan
  • Portugal
      • Braga, Portugal, 4710-243
        • Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)
      • Lisbon, Portugal, 1649035
        • Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
      • Porto, Portugal, 4200-072
        • Instituto Português de Oncologia do Porto Francisco Gentil, EPE
  • Reino Unido
    • England
      • Birmingham, England, Reino Unido, B9 5SS
        • Birmingham Heartlands Hospital
  • Romênia
      • Bucharest, Romênia, 022328
        • Institutul Clinic Fundeni - Centrul de Hematologie si Transplant Medular
      • Cluj-Napoca, Romênia, 400015
        • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
      • Iași, Romênia, 700483
        • Institutului Regional de Oncologie IASI
    • Dolj
      • Craiova, Dolj, Romênia, 200143
        • Spitalul Clinic Municipal Filantropia Craiova
  • Rússia
      • Saint Petersburg, Rússia, 197022
        • Academician I.P. Pavlov First St-Petersburg State Medical University
  • Taiwan
      • Changhua, Taiwan, 50544
        • Chang Bing Show Chwan Memorial Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taoyuan City, Taiwan, 333
        • Chang Gung Memorial Hospital - Linkou
  • Tcheca
      • Brno, Tcheca, 62500
        • Fakultni nemocnice Brno
      • Hradec Králové, Tcheca, 500 05
        • Fakultni nemocnice Hradec Kralove
  • Áustria
      • Salzburg, Áustria, 5020
        • Uniklinikum Salzburg
      • Vienna, Áustria, 1160
        • Klinik Ottakring

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Confirmed diagnosis of CLL/SLL requiring therapy, per iwCLL 2018 criteria
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Adequate organ function
  • Platelets greater than or equal to (≥)75 x 10⁹/liter (L) (≥50 × 10⁹/L for patients with evidence of bone marrow infiltrate), hemoglobin ≥8 grams/deciliter (g/dL), and absolute neutrophil count ≥0.75 x 10⁹/L
  • Kidney function: Estimated creatinine clearance ≥40 milliliters per minute (mL/min)

Exclusion Criteria:

  • Known or suspected Richter's transformation at any time preceding enrollment

  • Prior systemic therapy for CLL/SLL

  • Presence of 17p deletion

  • Central nervous system (CNS) involvement

  • Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])

  • Significant cardiovascular disease

  • Active hepatitis B or hepatitis C

  • Active cytomegalovirus (CMV) infection

  • Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection

  • Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count

  • Concurrent use of investigational agent or anticancer therapy except hormonal therapy

  • Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist

  • Vaccination with a live vaccine within 28 days prior to randomization

  • Patients with the following hypersensitivity:

    • Known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or bendamustine
    • Prior significant hypersensitivity to rituximab

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Arm A - Pirtobrutinib

Participants received pirtobrutinib 200 milligrams (mg) orally once daily in continuous 28-day cycles until disease progression or unacceptable toxicity.
Medicamento: Pirtobrutinib

Oral

Outros nomes:
  • LOXO-305
  • LY3527727
Comparador Ativo: Arm B - Bendamustine Plus Rituximab

Participants received bendamustine 90 milligrams per square meter (mg/m²) intravenously on Days 1 and 2 of each 28-day cycle (Cycles 1-6) plus rituximab 375 mg/m² intravenously on Cycle 1 Day 1, then 500 mg/m² on Day 1 of Cycles 2-6. Eligible participants in Arm B crossed over to receive pirtobrutinib following independent review committee (IRC)-confirmed progressive disease (PD).
Medicamento: Bendamustine

IV

Outros nomes:
  • Treanda
  • Levacto
  • Ribomustina
  • Treakisym
Medicamento: Rituximab

IV

Outros nomes:
  • Rituxan
  • MabThera
  • Riabni
  • Ruxiência
  • Truxima

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Arm A Compared to Arm B: Progression-free Survival (PFS), Assessed by Independent Review Committee (IRC)
Prazo: From randomization until documented disease progression or death (up to 40 months)

PFS, as assessed by IRC, is defined as the time from randomization until documented disease progression as per iwCLL (International Workshop on Chronic Lymphocytic Leukemia) 2018 criteria, or death from any cause, whichever occurs first.
From randomization until documented disease progression or death (up to 40 months)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Arm A Compared to Arm B: Progression-free Survival (PFS), Assessed by Investigator
Prazo: From randomization until documented disease progression or death (up to 40 months)

PFS, as assessed by investigator, is defined as the time from randomization until documented disease progression as per iwCLL (International Workshop on Chronic Lymphocytic Leukemia) 2018 criteria, or death from any cause, whichever occurs first.
From randomization until documented disease progression or death (up to 40 months)
To Evaluate the Effectiveness of Arm A Compared to Arm B: Overall Survival (OS)
Prazo: Up to approximately 5 years

Assessments of effectiveness include OS, assessed by investigator
Up to approximately 5 years
Arm A Compared to Arm B: Time to Next Treatment (TTNT), Assessed by Investigator
Prazo: From randomization until initiation of the subsequent anticancer therapy or death (up to 41 months)

TTNT is defined as time from the date of randomization to the date of initiation of the subsequent anticancer therapy for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) including the first dose date of pirtobrutinib for Arm B participants who crossed over to receive pirtobrutinib if applicable or death due to any cause, whichever occurs first.
From randomization until initiation of the subsequent anticancer therapy or death (up to 41 months)
Arm A Compared to Arm B: Percentage of Participants With Overall Response (ORR), Assessed by IRC
Prazo: From randomization until subsequent anticancer therapy, disease progression or death (up to 40 months)

ORR, as assessed by IRC, is defined as number of participants who achieved a best overall response of complete remission (CR), complete remission with an incomplete marrow recovery (CRi), nodular partial remission (nPR) or partial remission (PR) at or before the initiation of subsequent anticancer therapy, disease progression or death, divided by the total number of participants randomized to each treatment arm.
From randomization until subsequent anticancer therapy, disease progression or death (up to 40 months)
Arm A Compared to Arm B: Percentage of Participants With Overall Response (ORR), Assessed by Investigator
Prazo: From randomization until subsequent anticancer therapy, disease progression or death (up to 40 months)

ORR, as assessed by investigator, is defined as number of participants who achieved a best overall response of complete remission (CR), complete remission with an incomplete marrow recovery (CRi), nodular partial remission (nPR) or partial remission (PR) at or before the initiation of subsequent anticancer therapy, disease progression or death, divided by the total number of participants randomized to each treatment arm.
From randomization until subsequent anticancer therapy, disease progression or death (up to 40 months)
Arm A Compared to Arm B: Duration of Response (DOR), Assessed by IRC
Prazo: From first documented response until the first documented disease progression or death (up to 35 months)

DoR, as assessed by IRC, is defined as the time from the date of the first documented response (CR, CRi, nPR, or PR) until the first date of the documentation of disease progression as per iwCLL 2018 criteria, or the date of death from any cause, whichever occurs first.
From first documented response until the first documented disease progression or death (up to 35 months)
Arm A Compared to Arm B: Duration of Response (DOR), Assessed by Investigator
Prazo: From first documented response until the first documented disease progression or death (up to 35 months)

DoR, as assessed by investigator, is defined as the time from the date of the first documented response (CR, CRi, nPR, or PR) until the first date of the documentation of disease progression as per iwCLL 2018 criteria, or the date of death from any cause, whichever occurs first.
From first documented response until the first documented disease progression or death (up to 35 months)
Arm A Compared to Arm B: Time to Worsening (TTW) of CLL/SLL-related Symptoms as Measured by the EORTC QLQ-C30 and IL-58
Prazo: From randomization up to 37 months

A measure of CLL/SLL-related symptoms (CLL/SLL-related Symptoms score) was derived from 13 items: appetite loss, fatigue (3 items), pain, nausea, dyspnea, and insomnia from the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), and night sweats, fever/chills, and fatigue (3 items) from selected items of the EORTC Item Library set 58 (IL-58). First, a raw score was calculated as mean of the item responses, then a linear transformation was applied to obtain standardized score ranging from 0 to 100, with higher score representing worse symptoms. TTW of CLL/SLL-related symptoms was defined as the time from randomization to the earliest date of the first sustained worsening in its score from baseline, meeting or exceeding the meaningful within-person change (MWPC) threshold of +5.12 points or death from any cause. Sustained worsening required that the threshold be met at two consecutive assessment timepoints.
From randomization up to 37 months
Arm A Compared to Arm B: Time to Worsening (TTW) of Physical Functioning as Measured by the Physical Function Domain of the EORTC-QLQ-C30
Prazo: From randomization up to 37 months

Physical Functioning was assessed with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 items (QLQ-C30) Physical Function (PF) scale consisting of 5 items to measure the impact of the disease and its treatment on a participant's ability to perform everyday physical activities, calculated from responses to the five items, each scored on a 4 point scale (1 = not at all to 4 = very much). First, a raw score was calculated as mean of the item responses, then a linear transformation was applied to obtain standardized score ranging from 0 to 100, with higher score representing better functioning. TTW of PF was defined as the time from randomization to the earliest date of the first sustained worsening from baseline, with a decline in the meaningful within-person change (MWPC) threshold of -13.33 points or death from any cause. Sustained worsening required that the threshold be met at two consecutive assessment timepoints.
From randomization up to 37 months

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Arm A Compared to Arm B: Overall Survival, Assessed by Investigator
Prazo: From randomization until death from any cause (up to 41 months)

Overall survival (OS) is defined as the time from randomization until death from any cause. A descriptive analysis of OS was pre-specified based on the primary endpoint data cutoff.
From randomization until death from any cause (up to 41 months)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Loxo Oncology, Inc.

Colaboradores

Eli Lilly and Company

Investigadores

  • Diretor de estudo: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

23 de setembro de 2021

Conclusão Primária (Real)

11 de julho de 2025

Conclusão do estudo (Estimado)

1 de outubro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

24 de agosto de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

24 de agosto de 2021

Primeira postagem (Real)

27 de agosto de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

25 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 18088
  • LOXO-BTK-20023 (Outro identificador: Eli Lilly and Company)
  • J2N-OX-JZNP (Outro identificador: Eli Lilly and Company)
  • 2024-511599-33-00 (Ctis)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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