Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Une étude comparant le pirtobrutinib (LOXO-305) à la bendamustine plus rituximab (BR) chez des patients non traités atteints de leucémie lymphoïde chronique (LLC)/lymphome lymphocytaire de petite taille (SLL) (BRUIN-CLL-313)

24 septembre 2026 mis à jour par: Loxo Oncology, Inc.

Une étude ouverte et randomisée de phase 3 comparant le pirtobrutinib (LOXO-305) à la bendamustine plus le rituximab chez des patients non traités atteints de leucémie lymphoïde chronique/lymphome lymphocytaire de petite taille

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.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

282

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Arm A - Pirtobrutinib

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

Oral

Autres noms:
  • LOXO-305
  • LY3527727
Comparateur actif: 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).
Médicament: Bendamustine

IV

Autres noms:
  • Treanda
  • Levact
  • Ribomustine
  • Treakisym
Médicament: Rituximab

IV

Autres noms:
  • Rituxan
  • MabThera
  • Riabni
  • Ruxience
  • Truxima

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Arm A Compared to Arm B: Progression-free Survival (PFS), Assessed by Independent Review Committee (IRC)
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Arm A Compared to Arm B: Progression-free Survival (PFS), Assessed by Investigator
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Arm A Compared to Arm B: Overall Survival, Assessed by Investigator
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Loxo Oncology, Inc.

Collaborateurs

Eli Lilly and Company

Les enquêteurs

  • Directeur d'études: 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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

23 septembre 2021

Achèvement primaire (Réel)

11 juillet 2025

Achèvement de l'étude (Estimé)

1 octobre 2027

Dates d'inscription aux études

Première soumission

24 août 2021

Première soumission répondant aux critères de contrôle qualité

24 août 2021

Première publication (Réel)

27 août 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner