Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Een studie van Pirtobrutinib (LOXO-305) versus Bendamustine Plus Rituximab (BR) bij onbehandelde patiënten met chronische lymfatische leukemie (CLL)/klein lymfatisch lymfoom (SLL) (BRUIN-CLL-313)

24 september 2026 bijgewerkt door: Loxo Oncology, Inc.

Een open-label, gerandomiseerde fase 3-studie van pirtobrutinib (LOXO-305) versus bendamustine plus rituximab bij onbehandelde patiënten met chronische lymfatische leukemie/klein lymfatisch lymfoom

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

282

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Australië
    • New South Wales
      • Liverpool, New South Wales, Australië, 2170
        • Liverpool Hospital
      • Wentworthville, New South Wales, Australië, 2145
        • Westmead Hospital
    • Victoria
      • Frankston, Victoria, Australië, 3199
        • Peninsula Private Hospital
  • Brazilië
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazilië, 90035-903
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brazilië, 90050-170
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brazilië, 90110270
        • Centro Gaucho Integrado - Mae de Deus Center
    • São Paulo
      • Campinas, São Paulo, Brazilië, 13083-878
        • Hemocentro Unicamp
      • Jaú, São Paulo, Brazilië, 17210120
        • Fundação Doutor Amaral Carvalho
  • Bulgarije
      • Plovdiv, Bulgarije, 4000
        • UMHAT "Sveti Georgi" EAD
      • Sofia, Bulgarije, 1431
        • UMHAT 'Sv. Ivan Rilski', EAD
      • Sofia, Bulgarije, 1797
        • "SHATHD" EAD, Sofia
      • Stara Zagora, Bulgarije, 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
  • Frankrijk
      • Le Mans, Frankrijk, 72000
        • Hospitalier Le Mans
  • Hongarije
      • Debrecen, Hongarije, 4032
        • Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
      • Nyíregyháza, Hongarije, 4400
        • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
      • Székesfehérvár, Hongarije, 8000
        • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Italië
      • Bergamo, Italië, 24127
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
      • Brescia, Italië, 25123
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
      • Meldola, Italië, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
      • Milan, Italië, 20122
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
      • Milan, Italië, 20162
        • ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C
      • Monza, Italië, 20900
        • Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
      • Novara, Italië, 28100
        • Azienda Ospedale Maggiore Della Carita
      • Perugia, Italië, 06132
        • Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich)
      • Ravenna, Italië, 48020
        • Ospedale Santa Maria delle Croci
      • Terni, Italië, 05100
        • Azienda Ospedaliera Santa Maria Terni
      • Trieste, Italië, 34125
        • Azienda sanitaria integrata università di Trieste
    • Potenza
      • Rionero in Vulture, Potenza, Italië, 85028
        • Irccs Crob
  • Japan
      • Aomori, Japan, 030-8553
        • Aomori Prefectural Centeral Hospital
      • Fukoka-ken, Japan, 806 8501
        • JCHO Kyushu Hospital
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Nagoya City University Hospital
    • Chiba
      • Chiba, Chiba, Japan, 260-8717
        • Chiba Cancer Center
    • Fukui
      • Yoshida-Gun, Fukui, Japan, 910-1193
        • Fukui Medical University Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 0030006
        • Hokuyukai Sapporo Hokuyu Hospital
    • Kochi
      • Nankoku, Kochi, Japan, 783-8505
        • Kochi Medical School Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Tohoku University Hospital
      • Sendai, Miyagi, Japan, 9838520
        • NHO Sendai Medical Center
    • Saitama
      • Koshigaya, Saitama, Japan, 343 8555
        • Dokkyo Medical University - Koshigaya Hospital
    • Yamanshi
      • Chūō, Yamanshi, Japan, 409-3821
        • University of Yamanashi Hospital
  • Nieuw-Zeeland
      • Christchurch, Nieuw-Zeeland, 8011
        • Christchurch Hospital
      • Papatoetoe, Nieuw-Zeeland, 2025
        • Middlemore Clinical Trials
    • Auckland
      • Takapuna, Auckland, Nieuw-Zeeland, 0622
        • North Shore Hospital, Haematology Research
    • Bay of Plenty
      • Tauranga, Bay of Plenty, Nieuw-Zeeland, 3112
        • Tauranga Hospital
  • Oostenrijk
      • Salzburg, Oostenrijk, 5020
        • Uniklinikum Salzburg
      • Vienna, Oostenrijk, 1160
        • Klinik Ottakring
  • Polen
      • Biała Podlaska, Polen, 21500
        • KO-MED Centra Kliniczne
      • Bydgoszcz, Polen, 85-168
        • Szpital Uniwersytecki nr 1 im. Antoniego Jurasza
      • Katowice, Polen, 40519
        • Pratia Onkologia Katowice
      • Krakow, Polen, 30727
        • Pratia MCM Krakow
      • Lublin, Polen, 20-090
        • Centrum Onkologii Ziemi Lubelskiej
      • Torun, Polen, 87-100
        • Nasz Lekarz Osrodek Badan Klinicznych
      • Warsaw, Polen, 02781
        • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Cuire - Państwowy Instytut Badawczy
      • Wroclaw, Polen, 50-367
        • Uniwersytecki Szpital Kliniczny Klinika
    • Legnica
      • Iwaszkiewicza 5, Legnica, Polen, 59-220
        • Wojewodzki Szpital Specjalistyczny
    • Lubelskie V
      • Lublin, Lubelskie V, Polen, 20081
        • Klinika Hematoonkologii i Transplantacji Szpiku SPSK1 Lublin
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Polen, 80214
        • Uniwersyteckie Centrum Kliniczne
    • Poznan
      • Skorzewo, Poznan, Polen, 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
  • Roemenië
      • Bucharest, Roemenië, 022328
        • Institutul Clinic Fundeni - Centrul de Hematologie si Transplant Medular
      • Cluj-Napoca, Roemenië, 400015
        • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
      • Iași, Roemenië, 700483
        • Institutului Regional de Oncologie IASI
    • Dolj
      • Craiova, Dolj, Roemenië, 200143
        • Spitalul Clinic Municipal Filantropia Craiova
  • Rusland
      • Saint Petersburg, Rusland, 197022
        • Academician I.P. Pavlov First St-Petersburg State Medical University
  • Spanje
      • Barcelona, Spanje, 08041
        • Hospital de la Santa Creu i Sant Pau
      • Madrid, Spanje, 28040
        • Hospital Universitario Fundación Jiménez Díaz
      • Seville, Spanje, 41013
        • Hospital Universitario Virgen del Rocío
      • Seville, Spanje, 41014
        • Hospital Universitario Virgen de Valme
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spanje, 28050
        • Hospital Universitario HM Sanchinarro
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spanje, 33011
        • Hospital Universitario Central de Asturias
  • 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
  • Tsjechië
      • Brno, Tsjechië, 62500
        • Fakultni nemocnice Brno
      • Hradec Králové, Tsjechië, 500 05
        • Fakultni nemocnice Hradec Kralove
  • Verenigd Koninkrijk
    • England
      • Birmingham, England, Verenigd Koninkrijk, B9 5SS
        • Birmingham Heartlands Hospital
  • Verenigde Staten
    • California
      • Los Angeles, California, Verenigde Staten, 90027
        • California Research Institute
      • Whittier, California, Verenigde Staten, 90603
        • Innovative Clinical Research Institute
    • Florida
      • Coral Springs, Florida, Verenigde Staten, 33065
        • Oncology-Hematology Associates of West Broward
    • New Jersey
      • Brick, New Jersey, Verenigde Staten, 08724
        • New Jersey Center for Cancer Research
    • New York
      • Westbury, New York, Verenigde Staten, 11590
        • Clinical Research Alliance, Inc.
  • Zuid -Korea
      • Busan, Zuid -Korea, 47392
        • Inje Univ Busan Paik Hospital
    • Incheon-gwangyeoksi [Incheon]
      • Namdong-gu, Incheon-gwangyeoksi [Incheon], Zuid -Korea, 21565
        • Gachon University Gil Medical Center
    • Seoul
      • Seocho-Gu, Seoul, Zuid -Korea, 06591
        • The Catholic University of Korea-Seoul St. Mary's Hospital
    • Seoul, Korea
      • Seoul, Seoul, Korea, Zuid -Korea, 03080
        • Seoul National University Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Zuid -Korea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Seoul-teukbyeolsi [Seoul], Zuid -Korea, 06351
        • Samsung Medical Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Arm A - Pirtobrutinib

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

Oral

Andere namen:
  • LOXO-305
  • LY3527727
Actieve vergelijker: 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).
Geneesmiddel: Bendamustine

IV

Andere namen:
  • Treanda
  • Levac
  • Ribomustine
  • Treakisym
Geneesmiddel: Rituximab

IV

Andere namen:
  • Rituxan
  • Mab Thera
  • Riabni
  • Rust
  • Truxima

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Arm A Compared to Arm B: Progression-free Survival (PFS), Assessed by Independent Review Committee (IRC)
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Arm A Compared to Arm B: Progression-free Survival (PFS), Assessed by Investigator
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Arm A Compared to Arm B: Overall Survival, Assessed by Investigator
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Loxo Oncology, Inc.

Medewerkers

Eli Lilly and Company

Onderzoekers

  • Studie directeur: 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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

23 september 2021

Primaire voltooiing (Werkelijk)

11 juli 2025

Studie voltooiing (Geschat)

1 oktober 2027

Studieregistratiedata

Eerst ingediend

24 augustus 2021

Eerst ingediend dat voldeed aan de QC-criteria

24 augustus 2021

Eerst geplaatst (Werkelijk)

27 augustus 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 september 2026

Laatste update ingediend die voldeed aan QC-criteria

24 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren