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Un estudio de la combinación de ibrutinib más venetoclax versus clorambucilo más obinutuzumab para el tratamiento de primera línea de participantes con leucemia linfocítica crónica (LLC)/linfoma linfocítico de células pequeñas (SLL) (GLOW)

2 de noviembre de 2026 actualizado por: Janssen Research & Development, LLC

Un estudio aleatorizado, abierto, de fase 3 de la combinación de ibrutinib más venetoclax versus clorambucilo más obinutuzumab para el tratamiento de primera línea de sujetos con leucemia linfocítica crónica (LLC)/linfoma linfocítico de células pequeñas (SLL).

The purpose of this study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review Committee (IRC).

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

211

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Bélgica
      • Anderlecht, Bélgica, 1070
        • Institut - Jules Bordet
      • Antwerp, Bélgica, 2060
        • ZNA Stuivenberg
      • Ghent, Bélgica, 9000
        • Universitair Ziekenhuis Gent
      • Hasselt, Bélgica, 3500
        • Virga Jessa Ziekenhuis
      • Leuven, Bélgica, 3000
        • UZ Leuven Gasthuisberg
  • Canadá
    • Alberta
      • Calgary, Alberta, Canadá, T2N 5G2
        • Arthur J E Child Comprehensive Cancer Centre
      • Edmonton, Alberta, Canadá, T6G 1Z2
        • Cross Cancer Institute
    • Ontario
      • Hamilton, Ontario, Canadá, L8V 5C2
        • Juravinski Cancer Centre
      • Ottawa, Ontario, Canadá, K1H 8L6
        • The Ottawa Hospital - General Campus
    • Quebec
      • Montreal, Quebec, Canadá, H3T 1E2
        • Jewish General Hospital
      • Montreal, Quebec, Canadá, H1T 2M4
        • CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
  • Chequia
      • Brno, Chequia, 625 00
        • Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika
      • Hradec Králové, Chequia, 500 05
        • Fakultni nemocnice Hradec Kralove
      • Ostrava, Chequia, 708 52
        • Fakultni Nemocnice Ostrava
      • Pilsen, Chequia, 323 00
        • Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni
      • Prague, Chequia, 128 08
        • Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
  • Dinamarca
      • Aalborg, Dinamarca, 9000
        • Aalborg University Hospital
      • Aarhus, Dinamarca, 8200
        • Aarhus Universitetshospital
      • Copenhagen, Dinamarca, 2100
        • Rigshospitalet
      • Copenhagen, Dinamarca, 2100
        • Rigshospitalet 1
      • Odense C, Dinamarca, 5000
        • Odense Universitetshospital
      • Roskilde, Dinamarca, DK- 4000
        • Roskilde Sygehus
  • España
      • Barcelona, España, 08041
        • Hosp. de La Santa Creu I Sant Pau
      • Barcelona, España, 08036
        • Hosp Clinic de Barcelona
      • Barcelona, España, 08035
        • Hosp Univ Vall D Hebron
      • Madrid, España, 28034
        • Hospital Ramon y Cajal
      • Madrid, España, 28007
        • Hosp. Gral. Univ. Gregorio Maranon
      • Madrid, España, 28031
        • Hosp. Univ. Infanta Leonor
      • Madrid, España, 28006
        • Hosp. Univ. de La Princesa
      • Madrid, España, 28040
        • Hosp Univ Fund Jimenez Diaz
      • Pamplona, España, 31008
        • Clinica Univ. de Navarra
      • Salamanca, España, 37007
        • Hospital Clinico Universitario Salamanca
      • Seville, España, 41013
        • Hosp. Virgen Del Rocio
  • Estados Unidos
    • Kentucky
      • Louisville, Kentucky, Estados Unidos, 40207
        • Norton Cancer Institute
    • New Jersey
      • Hackensack, New Jersey, Estados Unidos, 07601
        • John Theurer Cancer Center
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos, 28204
        • Novant Health
  • Francia
      • Clermont-Ferrand, Francia, 63000
        • CHU de Clermont Ferrand
      • Lille, Francia, 59000
        • Hopital Claude Huriez
      • Montpellier, Francia, 34295
        • CHU Montpellier
      • Pessac, Francia, 33604
        • Hopital Haut Leveque Service Maladie Du Sang
      • Reims, Francia, 51100
        • Centre Hospitalier Universitaire de Reims, Hôpital Robert Debré
      • Toulouse, Francia, 31059
        • Institut Universitaire du Cancer Toulouse Oncopole
      • Tours, Francia, 37044
        • CHU Bretonneau
      • Vandœuvre-lès-Nancy, Francia, 54511
        • CHU-Nancy
      • Villejuif, Francia, 94805
        • Institut Gustave Roussy
  • Israel
      • Haifa, Israel, 31048
        • Bnai Zion Medical Center
      • Haifa, Israel, 34362
        • Carmel Medical Center
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center
      • Nahariya, Israel, 22100
        • Western Galilee Medical Center
      • Ramat Gan, Israel, 52621
        • Sheba Medical Center
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
  • Países Bajos
      • Almere Stad, Países Bajos, 1315RA
        • Flevoziekenhuis
      • Amsterdam, Países Bajos, 1105 AZ
        • Academic Medical Center
      • Amsterdam, Países Bajos, 1091AC
        • OLVG
      • Delft, Países Bajos, 2625 AD
        • Reinier de Graaf Gasthuis
      • Dordrecht, Países Bajos, 3318 AT
        • Albert Schweitzer Ziekenhuis
      • Eindhoven, Países Bajos, 5623 EJ
        • Catharinaziekenhuis
      • Hoofddorp, Países Bajos, 2134 TM
        • Spaarne Gasthuis
      • Sittard-Geleen, Países Bajos, 6162 BG
        • Zuyderland Medical Center
      • Sneek, Países Bajos, 8601 ZK
        • Antonius hospital
      • The Hague, Países Bajos, 2512 VA
        • MC Haaglanden
      • Tilburg, Países Bajos, 5022 GC
        • Elisabeth zkh
  • Polonia
      • Chorzów, Polonia, 41-500
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
      • Koszalin, Polonia, 75-581
        • Wojewodzki Szpital Specjalistyczny im Janusza Korczaka
      • Lodz, Polonia, 93 510
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
      • Lublin, Polonia, 20-081
        • Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
      • Warsaw, Polonia, 02 776
        • Instytut Hematologii i Transfuzjologii
  • Reino Unido
      • Birmingham, Reino Unido, B9 5ST
        • Birmingham Heartlands Hospital
      • Cambridge, Reino Unido, CB2 0QQ
        • Addenbrookes Hospital
      • Charterhouse Square, Reino Unido, EC1M 6BQ
        • Queen Mary University of London
      • Glasgow, Reino Unido, G42 9LF
        • New Victoria Hospital
      • Leeds, Reino Unido, LS9 7T
        • St James's Hospital
      • Plymouth, Reino Unido, PL6 8DH
        • Derriford Hospital
      • Romford, Reino Unido, RM7 0AG
        • Barking Havering and Redbridge University Hospitals NHS Trust
      • Sheffield, Reino Unido, S10 2JF
        • Royal Hallamshire Hospital
  • Rusia
      • Moscow, Rusia, 125284
        • Moscow Multidisciplinary Scientific and Clinical Center named after S P Botkin
      • Moscow, Rusia, 125284
        • S.P. Botkin Moscow City Clinical Hospital
      • Nizhny Novgorod, Rusia, 603126
        • Nizhniy Novgorod Region Clinical Hospital
      • Ryazan, Rusia, 390039
        • Ryazan Regional Clinical Hospital
      • Saint Petersburg, Rusia, 193024
        • St.-Petersburg Clinical Research Institute of Hematology and Transfusiology
      • Saint Petersburg, Rusia, 197341
        • FSBIFederal Centre of Heart, Blood and Endocrinology named after V.A.Almazov MoH of the RF
  • Suecia
      • Luelå, Suecia, 97180
        • Sunderby Sjukhus Medicinkliniken
      • Stockholm, Suecia, 171 76
        • Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm
  • Turquía (Türkiye)
      • Ankara, Turquía (Türkiye), 06500
        • Gazi Universitesi Tip Fakultesi
      • Ankara, Turquía (Türkiye), 06620
        • Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
      • Istanbul, Turquía (Türkiye), 34365
        • V K V Amerikan Hastanesi
      • Izmir, Turquía (Türkiye), 35340
        • Dokuz Eylul Universitesi Tip Fakultesi
      • Samsun, Turquía (Türkiye), 55280
        • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Adult participants who are: (a) greater than or equal to (>=) 65 years old or, (b) 18 to 64 years old and have at least 1 of the following:

    1. Cumulative Illness Rating Scale (CIRS) score > 6
    2. Creatinine clearance (CrCl) estimated less than (<) 70 milliliter per minute (mL/min) using Cockcroft-Gault equation

  • Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that meets International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria

  • Measurable nodal disease (by computed tomography [CT]), defined as at least one lymph node > 1.5 centimeter (cm) in longest diameter

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Grade less than or equal to (<=) 2

  • Active CLL/SLL requiring treatment per the iwCLL criteria

Exclusion Criteria:

  • Prior anti-leukemic therapy for CLL or SLL
  • Presence of deletion of the short arm of chromosome 17 (del17p) or known TP53 mutation detected at a threshold of >10 percent (%) variable allele frequency (VAF)
  • Major surgery within 4 weeks of first dose of study treatment
  • Known bleeding disorders (example, von Willebrand's disease or hemophilia)
  • Central nervous system (CNS) involvement or suspected Richter's syndrome

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Treatment Arm A: Ibrutinib and Venetoclax (I+VEN)

Participants will initially receive ibrutinib (420 mg [milligrams]/day) for 3 cycles. Venetoclax dose ramp up (from 20 to 400 mg over 5 weeks) will begin at Cycle 4 and the combination of ibrutinib and venetoclax will be given for 12 cycles (each cycle is equivalent to 28 days). Participants who subsequently develop progressive disease may enter to Subsequent Therapy Phase to receive single-agent ibrutinib until disease progression or unacceptable toxicity.
Droga: Ibrutinib

Participants will receive ibrutinib 420 mg orally once daily up to 15 cycles.

Droga: Venetoclax

Participants will receive venetoclax in combination with ibrutinib for a total of 12 cycles, beginning at Cycle 4. For the first 5 weeks of venetoclax treatment, the treatment dose will be ramped up from 20 to 400 mg.

Droga: Ibrutinib (as Subsequent Therapy)

Participants will receive ibrutinib 420 mg orally once daily until disease progression or unacceptable toxicity during the subsequent therapy phase.
Comparador activo: Treatment Arm B: Chlorambucil and Obinutuzumab (G-Clb)

Participants will receive chlorambucil and obinutuzumab (G-Clb) for 6 cycles. Participants will receive obinutuzumab, 1000 mg intravenously (IV) on Days 1, 8 and 15 of Cycle 1, and on Day 1 of Cycles 2 to 6 and chlorambucil 0.5 milligrams per kilogram (mg/kg) body weight, on Days 1 and 15 of Cycles 1 to 6. Participants who subsequently develop progressive disease may enter to Subsequent Therapy Phase to receive single-agent ibrutinib until disease progression or unacceptable toxicity.
Droga: Ibrutinib (as Subsequent Therapy)

Participants will receive ibrutinib 420 mg orally once daily until disease progression or unacceptable toxicity during the subsequent therapy phase.

Droga: Chlorambucil

Participants will receive chlorambucil at a dose of 0.5 mg/kg body weight on Days 1 and 15 of Cycles 1 to 6.

Droga: Obinutuzumab

Participant will receive obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1, and Day 1 of Cycles 2 to 6.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression Free Survival (PFS)
Periodo de tiempo: Up to 2 years 10 months

PFS: time between date of randomization and date of disease progression, as assessed by IRC, or date of death due to any cause, whichever occurs first, regardless of use of subsequent anti-cancer therapy prior to PD or death using iWCLL2008 criteria : New enlarged lymph nodes >15 mm, new hepatomegaly or splenomegaly, or other organ infiltrates, bone lesion, ascites or pleural effusion due to CLL; >=50% increase in longest diameter (LDi) from nadir in existing lymph node (LDi >15 mm) or >=50% increase from nadir in sum of diameters of multiple nodes (and at least 1 node with LDi >15 mm); >=50% increase from nadir in enlargement of liver/spleen; >=50% increase from baseline in lymphocyte count (ALC; to >=5*10^9/L); or >=50% increase from nadir in ALC in >=2 serial assessments if ALC is >=30000*10^9/L and lymphocyte doubling time is rapid unless considered treatment-related lymphocytosis; new cytopenia attributable to CLL; transformation to more aggressive histology.
Up to 2 years 10 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Minimal Residual Disease (MRD) Negative Rate
Periodo de tiempo: Up to 2 years 10 months

MRD-negative rate is defined as the percentage of participants who achieved MRD-negative status (that is, less than [<] 1 chronic lymphocytic leukemia (CLL) cell per 10,000 leukocytes or <0.01 percentage [%]) in the bone marrow as assessed by next-generation sequencing (NGS). Participants with missing MRD data were considered MRD positive.
Up to 2 years 10 months
Complete Response Rate (CRR)
Periodo de tiempo: Up to 2 years 10 months

Complete response rate is defined as the percentage of participants who achieved complete response or complete response with an incomplete marrow recovery (CRi) on or prior to initiation of subsequent anti-leukemic therapy per the IRC assessment. International Workshop on Chronic Lymphocytic Leukemia (iWCLL) 2008 criteria: CR- No lymphadenopathy and hepatosplenomegaly, no constitutional symptoms, neutrophils >1.5*10^9/liter (L), platelets >100*10^9/L, Hgb >11 gram per deciliter (g/dL), absolute lymphocyte count <4000/microliter (mcL) and normocellular bone marrow with <30% lymphocytes and no B lymphoid nodules; CRi- CR with incomplete recovery of bone marrow.
Up to 2 years 10 months
Overall Response Rate (ORR)
Periodo de tiempo: Up to 2 years 10 months

ORR: percentage of participants who achieved best overall response of either CR, CRi, nodular PR (nPR) and partial response (PR). iWCLL 2008 criteria: CR- No lymphadenopathy and hepatosplenomegaly, no constitutional symptoms, neutrophils >1.5*10^9/liter (L), platelets >100*10^9/L, Hgb >11 g/dL and ALC <4000/mcL, normocellular bone marrow with <30% lymphocytes and no B lymphoid nodules; CRi- CR with incomplete recovery of bone marrow; nPR- participants meet criteria for CR, but bone marrow biopsy shows B-lymphoid nodules (reflecting residual disease); PR-2 of following when abnormal at baseline: >=50% decrease in ALC, >=50% decrease in sum of products of multiple nodes, >=50% decrease in enlargement of spleen or liver; and 1 of following: neutrophils >1.5*10^9/L, Platelets >100*10^9/L and Hgb>11 g/dL or >=50% improvement over baseline in any of these; 50% reduction in bone marrow infiltrates or B lymphoid nodules; no new enlarged nodes or new hepatosplenomegaly.
Up to 2 years 10 months
Overall Survival (OS)
Periodo de tiempo: Up to 4 years 10 months

OS is defined as the time from date of randomization to date of death from any cause.
Up to 4 years 10 months
Duration of Response (DOR)
Periodo de tiempo: Up to 2 years 10 months

DOR is defined as the interval between the date of initial documentation of a response including partial response with lymphocytosis (PRL) and the date of first documented evidence of PD or death or date of censoring per the IRC assessment. iWCLL 2008 criteria for PD: New enlarged nodes >1.5 cm, new hepatomegaly or splenomegaly, or other organ infiltrates; >= 50% increase from nadir in existing lymph node or >=50% increase from nadir in sum of product of diameters of multiple nodes; >=50% increase from nadir in enlargement of liver or spleen; >=50% increase from baseline in lymphocyte count (and to >=5*10^9/L) unless considered treatment-related lymphocytosis; new cytopenia (Hemoglobin b or platelets) attributable to CLL; transformation to a more aggressive histology.
Up to 2 years 10 months
Time-to-Next Treatment
Periodo de tiempo: Up to 2 years 10 months

Time-to-next treatment was measured from the date of randomization to the start date of any subsequent anti-leukemic therapy.
Up to 2 years 10 months
Time to Worsening as Measured by Using EuroQol 5 Dimension 5 Level Questionnaire (EQ-5D-5L)
Periodo de tiempo: Up to 2 years 10 months

Time to worsening= time interval (months) from randomization to first observation of deterioration. EQ-5D-5L consists of a 5-item descriptive system and the EuroQol visual analog scale (EQ-5D VAS). EQ-5D-VAS self-rating records respondent's own assessment of his/her overall health status at time of completion, on scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Worsening is defined as a decrease of >= 7 points (on a 0-100 scale).

EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe participant's current health state. Responses for 5 dimensions are combined into a 5-digit number describing respondents health state that can be converted into a single index value or utility score (using the United Kingdom weights), ranging from -1 to 1, where lower scores indicate a worse health status. Worsening is defined as a decrease of >=0.08 points (on a 0-1 scale).
Up to 2 years 10 months
Time to Worsening Measured by European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ)-C30)
Periodo de tiempo: Up to 2 years 10 months

Time to worsening= time interval from randomization to first observation of deterioration. EORTC QLQ-C30 includes 30 separate items: 5 functional scales (physical, role, emotional, cognitive, and social Functioning), 1 global health status (GHS) and QoL scale, 3 symptom scales (fatigue, nausea/vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Each item, except GHS, is answered on 4-point scale (1=not at all to 4=very much) and GHS is measured on 1-7 scale: 1=very poor and 7=excellent. Scores derived using validated scoring algorithms as per EORTC QLQ-C30 Manual and linearly transformed in a range from 0-100. For functional and global QoL scales, higher scores=better level of functioning/QoL. For symptom-oriented scales, higher score=more severe symptoms. Worsening in functional and global health scores=decrease of >=10 points (on 0-100 scale) and in symptom scores=increase of >=10 points (on 0-100 scale).
Up to 2 years 10 months
Time to Worsening and Time to Improvement as Measured by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score
Periodo de tiempo: Up to 2 years 10 months

Responses to the 13-item FACIT Fatigue Scale are reported on a 5-point categorical response scale ranging from 0 (not at all) to 4 (very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). Time to Worsening is defined as time interval (months) from randomization to first observation of deterioration. Worsening is defined as a decrease >= 3 points (on a 0-52 scale). Time to improvement is defined as the time interval (months) from randomization to the first observation of improvement. Improvement is defined as an increase >=3 points (on a 0-52 scale).
Up to 2 years 10 months
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
Periodo de tiempo: Up to 4 years 10 months

An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Up to 4 years 10 months
Number of Participants With Abnormal Clinical Laboratory Findings
Periodo de tiempo: Up to 4 years 10 months

Number of participants with abnormal clinical laboratory findings (hematology and serum chemistry) were reported.
Up to 4 years 10 months
Percentage of Participants With Sustained Hemoglobin Improvement
Periodo de tiempo: Up to 2 years 10 months

Sustained hemoglobin improvement is defined as the percentage of participants who achieved an increase in hemoglobin levels from baseline by >= 2 grams per deciliter (g/dL) and lasts for at least 56 days without blood transfusion or growth factors.
Up to 2 years 10 months
Percentage of Participants With Sustained Platelet Improvement
Periodo de tiempo: Up to 2 years 10 months

Sustained platelet improvement is defined as the percentage of participants who achieved an increase in platelet levels from baseline by >= 50% and lasts for at least 56 days without blood transfusion or growth factors.
Up to 2 years 10 months
Plasma Concentration of Ibrutinib and Venetoclax
Periodo de tiempo: Ibrutinib: Pre-dose-Day 1 of Cycles 2, 3, 5 and 6 (each cycle is defined as 28 days), Venetoclax: Pre-dose-Day 1 of Cycles 5 and 6

Plasma concentrations of ibrutinib and venetoclax were determined by validated liquid chromatography-tandem mass spectrometry.
Ibrutinib: Pre-dose-Day 1 of Cycles 2, 3, 5 and 6 (each cycle is defined as 28 days), Venetoclax: Pre-dose-Day 1 of Cycles 5 and 6

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Janssen Research & Development, LLC

Colaboradores

Pharmacyclics LLC.

Investigadores

  • Director de estudio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

17 de abril de 2018

Finalización primaria (Actual)

26 de febrero de 2021

Finalización del estudio (Estimado)

5 de abril de 2029

Fechas de registro del estudio

Enviado por primera vez

6 de marzo de 2018

Primero enviado que cumplió con los criterios de control de calidad

6 de marzo de 2018

Publicado por primera vez (Actual)

12 de marzo de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CR108428
  • 2017 (Subvención/contrato del NIH de EE. UU.)
  • 2017-004699-77 (Número EudraCT)
  • 54179060CLL3011 (Otro identificador: Janssen Research & Development, LLC)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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