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NCT03235544CompletedPhase 2

A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor

A Phase 2, Open-Label, 2-Cohort, Multicenter Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)

Source: ClinicalTrials.gov · Last updated 18 Mar 2025

Brief summary (registry, in English)

This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in participants with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
162 (actual)
First submitted
27 Jul 2017
Start date
20 Nov 2017
Primary completion date
30 Apr 2024
Lead sponsor
Incyte Corporation
NCT number
NCT03235544
EudraCT number
2017-003148-19

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 162
  • From 20 Nov 2017 to the primary completion date, 30 Apr 2024
  • 103 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment with idelalisib, other selective phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitors, or a pan PI3K inhibitor.
  • Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of first dose of study treatment.

Other illness

  • History of central nervous system lymphoma (either primary or metastatic).
  • Active graft-versus-host disease.
  • Liver disease: Participants positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for hepatitis B virus-deoxyribonucleic acid (HBV-DNA). Participants positive for anti-hepatitis C virus (HCV) antibody will be eligible if they are negative for HCV-ribonucleic acid (RNA).

Who the study is looking for

  • Men and women, aged 18 years or older.
  • Documented failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent treatment regimen.
  • Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (103)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institut Jules Bordet
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BrusselsBelgiumUnknown status
Universitair Ziekenhuis Gent
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GhentBelgiumUnknown status
Hôpital de Jolimont
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La LouvièreBelgiumUnknown status
Universitaire Ziekenhuis Leuven - Gasthuisberg
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LeuvenBelgiumUnknown status
Fakultni nemocnice Hradec Kralove
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Hradec KrálovéCzechiaUnknown status
Charles University General Hospital
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PragueCzechiaUnknown status
Fakultni nemocnice Kralovske Vinohrady
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PragueCzechiaUnknown status
Fakultni Nemocnice Kralovske Vinohadry, Interni Hematologicka Klinika
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PragueCzechiaUnknown status
Praxis Brudler, Heinrich, Bangerter
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AugsburgGermanyUnknown status
Universitaetsklinikum - Essen
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EssenGermanyUnknown status
Universit�Tsklinikum Essen
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EssenGermanyUnknown status
Justus-Liebig University
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GiessenGermanyUnknown status
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
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MainzGermanyUnknown status
Kliniken Maria Hilf
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MönchengladbachGermanyUnknown status
Rotkreuzklinikum Munich
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MünchenGermanyUnknown status
Universit�Tsklinikum Ulm
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UlmGermanyUnknown status
Aalborg University Hospital
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AalborgDenmarkUnknown status
Aarhus Universitets Hospital
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AarhusDenmarkUnknown status
Odense Universitetshospital (Ouh) (Odense University Hospital)
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Odense CDenmarkUnknown status
Zealand University Hospital
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RoskildeDenmarkUnknown status
Hospital del Mar
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BarcelonaSpainUnknown status
Institut Catala d'Oncologia
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BarcelonaSpainUnknown status
Hospital Universitari Mutua Terrassa
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BarcelonaSpainUnknown status
Hospital General Universitari Vall d Hebron
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BarcelonaSpainUnknown status
Hospital Universitario De Burgos
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BurgosSpainUnknown status
Hospital Universitario de la Paz
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MadridSpainUnknown status
Hospital General Universitario Gregorio Marañón
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MadridSpainUnknown status
Fundación Jiménez Díaz University Hospital
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MadridSpainUnknown status
Md Anderson Cancer Centre Madrid
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MadridSpainUnknown status
Hospital Universitario 12 de Octubre
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MadridSpainUnknown status
Hospital Universitario Ramón y Cajal
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MadridSpainUnknown status
Hospital General Universitario Morales Meseguer
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MurciaSpainUnknown status
Complejo Hospitalario de Navarra
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PamplonaSpainUnknown status
Hospital Clinico Universitario de Salamanca
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SalamancaSpainUnknown status
Hospital Universitario Virgen del Rocio
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SevilleSpainUnknown status
Hospital Universitario Y Politecnic La Fe
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ValenciaSpainUnknown status
Hospital Universitario Dr. Peset
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ValenciaSpainUnknown status
Hospital Arnau de Vilanova
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ValenciaSpainUnknown status
Avicenne Hospital
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BobignyFranceUnknown status
Chu de Clermont - Ferrand- Hospital Estaing
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Clermont-FerrandFranceUnknown status
Centre Hospitalier Universitaire Henri Mondor
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CréteilFranceUnknown status
university Hospital Grenoble
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GrenobleFranceUnknown status
Centre Hospitalier Departemental - La-Roche-Sur-Yon - Les Oudairies
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La Roche-sur-YonFranceUnknown status
Centre Hospitalier Universitaire de Grenoble
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La TroncheFranceUnknown status
Centre Hospitalier de Versailles
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Le ChesnayFranceUnknown status
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
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LyonFranceUnknown status
Centre Antoine Lacassagne
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NiceFranceUnknown status
H�Pital Universitaire Piti�-Salp�Tri�Re
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ParisFranceUnknown status
Hopital Saint Louis
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ParisFranceUnknown status
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceUnknown status
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceUnknown status
Centre Henri Becquerel
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RouenFranceUnknown status
Chru Hopitaux de Tours Hospital Bretonneau
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ToursFranceUnknown status
Institute Gustave Roussy (Igr)
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VillejuifFranceUnknown status
Birmingham Heartlands Hospital
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BirminghamUnited KingdomUnknown status
Western General Hospital
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EdinburghUnited KingdomUnknown status
University College London Hospitals (UCLH)
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LondonUnited KingdomUnknown status
Derriford Hospital
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PlymouthUnited KingdomUnknown status
Royal Hallamshire Hospital
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SheffieldUnited KingdomUnknown status
Rambam Medical Center
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HaifaIsraelUnknown status
Hadassah Hebrew University Medical Center
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JerusalemIsraelUnknown status
Hadassah Hebrew University Medical Center Ein Karem Hadassah
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JerusalemIsraelUnknown status
Rabin Medical Center- Beilinson Hospital
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Petah TikvaIsraelUnknown status
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelUnknown status
Centro Ricerche Cliniche
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BolognaItalyUnknown status
Azienda Policlinico Vittorio Emanuele
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CataniaItalyUnknown status
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyUnknown status
Ospedale Niguarda Ca Granda
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MilanItalyUnknown status
Grande Ospedale Metropolitano Niguarda
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MilanItalyUnknown status
A.O.U. Di Modena - Policlinico
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ModenaItalyUnknown status
A. O. U. Federico II
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NaplesItalyUnknown status
AOU "Maggiore della Carità"
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NovaraItalyUnknown status
Ospedali Riuniti Villa Sofia - Cervello
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PalermoItalyUnknown status
Sapienza University
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RomeItalyUnknown status
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte
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SienaItalyUnknown status
Azienda Ospedaliero Universitaria Città della salute e della Scienza
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TorinoItalyUnknown status
Beskidzkie Centrum Onkologii im. Jana Pawla II
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Bielsko-BialaPolandUnknown status
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
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BrzozówPolandUnknown status
University Clinical Center
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GdanskPolandUnknown status
Pratia MCM Krakow
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KrakowPolandUnknown status
Nu-Med Centrum Diagnostykii I Terapii Onkologicznej
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Tomaszów MazowieckiPolandUnknown status
Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie
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WarsawPolandUnknown status
Rocky Mountain Cancer Center - Aurora
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AuroraUnited StatesUnknown status
Texas Oncology
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AustinUnited StatesUnknown status
University of Alabama at Birmingham, Comprehensive Cancer Center
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BirminghamUnited StatesUnknown status
ASCLEPES Research Centers
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BrooksvilleUnited StatesUnknown status
Rush University Medical Center
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ChicagoUnited StatesUnknown status
Oncology Hematology Care, Inc
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CincinnatiUnited StatesUnknown status
Duke University Medical Center
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DurhamUnited StatesUnknown status
Willamette Valley Cancer Institute
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EugeneUnited StatesUnknown status
Gettysburg Cancer Center
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GettysburgUnited StatesUnknown status
Hattiesburg Clinic Hematology
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HattiesburgUnited StatesUnknown status
Loyola University Medical Center
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MaywoodUnited StatesUnknown status
Clinical Research Alliance, Inc.
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New Hyde ParkUnited StatesUnknown status
Illinois Cancer Specialists
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NilesUnited StatesUnknown status
Kaiser Permanente Northwest
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PortlandUnited StatesUnknown status
Texas Oncology - San Antonio
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San AntonioUnited StatesUnknown status
St Joseph Heritage Healthcare
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Santa RosaUnited StatesUnknown status
Moffitt Cancer Center
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TampaUnited StatesUnknown status
Renovatio Clinical
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The WoodlandsUnited StatesUnknown status
Texas Oncology - Tyler
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TylerUnited StatesUnknown status
Bond & Steele Clinic, P.A.
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Winter HavenUnited StatesUnknown status
Yakima Valley Memorial Hospital/North Star
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YakimaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.