Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Eine Studie zur Kombination von Ibrutinib plus Venetoclax versus Chlorambucil plus Obinutuzumab zur Erstlinienbehandlung von Teilnehmern mit chronischer lymphatischer Leukämie (CLL)/kleinem lymphatischem Lymphom (SLL) (GLOW)

2. November 2026 aktualisiert von: Janssen Research & Development, LLC

Eine randomisierte, offene Phase-3-Studie zur Kombination von Ibrutinib plus Venetoclax versus Chlorambucil plus Obinutuzumab zur Erstlinienbehandlung von Patienten mit chronischer lymphatischer Leukämie (CLL)/kleinem lymphatischem Lymphom (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).

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

211

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Arzneimittel: Ibrutinib

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

Arzneimittel: 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.

Arzneimittel: Ibrutinib (as Subsequent Therapy)

Participants will receive ibrutinib 420 mg orally once daily until disease progression or unacceptable toxicity during the subsequent therapy phase.
Aktiver Komparator: 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.
Arzneimittel: Ibrutinib (as Subsequent Therapy)

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

Arzneimittel: 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.

Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Progression Free Survival (PFS)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Minimal Residual Disease (MRD) Negative Rate
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Janssen Research & Development, LLC

Mitarbeiter

Pharmacyclics LLC.

Ermittler

  • Studienleiter: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

17. April 2018

Primärer Abschluss (Tatsächlich)

26. Februar 2021

Studienabschluss (Geschätzt)

5. April 2029

Studienanmeldedaten

Zuerst eingereicht

6. März 2018

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. März 2018

Zuerst gepostet (Tatsächlich)

12. März 2018

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CR108428
  • 2017 (US NIH Stipendium/Vertrag)
  • 2017-004699-77 (EudraCT-Nummer)
  • 54179060CLL3011 (Andere Kennung: Janssen Research & Development, LLC)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren