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NCT03126019CompletedPhase 2

A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma

A Phase 2, Multicenter, Open-Label Study of INCB050465, a PI3Kδ Inhibitor in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)

Source: ClinicalTrials.gov · Last updated 14 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The purpose of this study is to assess the objective response rate of parsaclisib treatment in participants with relapsed or refractory follicular lymphoma.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
126 (actual)
First submitted
20 Apr 2017
Start date
14 Mar 2018
Primary completion date
26 Feb 2021
Lead sponsor
Incyte Corporation
NCT number
NCT03126019
EudraCT number
2017-001624-22

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 126
  • From 14 Mar 2018 to the primary completion date, 26 Feb 2021
  • 83 sites in 13 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.
  • Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).
  • Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of study treatment administration.

Other illness

  • History of central nervous system lymphoma (either primary or metastatic).
  • Active graft-versus-host 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).

Other

  • Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.

Who the study is looking for

  • Aged 18 years or older.
  • Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (NHL) (follicular lymphoma) Grade 1, 2, and 3a.
  • Ineligible for hematopoietic stem cell transplant.
  • Must have been treated with at least 2 prior systemic therapies.
  • Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures \> 1.5 cm in the longest dimension and ≥ 1.0 cm in the longest perpendicular dimension as assessed by computed tomography or magnetic resonance imaging.
  • Must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

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

Full criteria on ClinicalTrials.gov

Sites (83)

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

SiteCityCountrySite status
St Vincent's Hospital Sydney
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DarlinghurstAustraliaUnknown status
Western Health
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St AlbansAustraliaUnknown status
Border Medical Oncology
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WodongaAustraliaUnknown status
Santa Cabrini Hospital
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MontrealCanadaUnknown status
Saint John Regional Hospital
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Saint JohnCanadaUnknown status
Sunnybrook Health Science Centre
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TorontoCanadaUnknown status
University Hospital Hradec Kralove
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Hradec KrálovéCzechiaUnknown status
Fakultni nemocnice Ostrava
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OstravaCzechiaUnknown status
Fakultni nemocnice v Motole
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PragueCzechiaUnknown status
University Hospital Kralovkse Vinohrady
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PragueCzechiaUnknown status
Univerzita Karlova V Praze 1. Lekarska Fakulta
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PragueCzechiaUnknown status
Bag Arnoldstr. Dresden
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DresdenGermanyUnknown status
University Medical Center Freiburg
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Freiburg im BreisgauGermanyUnknown status
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
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MainzGermanyUnknown status
University Hospital Mannheim
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MannheimGermanyUnknown status
Aalborg University Hospital
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AalborgDenmarkUnknown status
Odense Universitetshospital (Ouh) (Odense University Hospital)
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Odense CDenmarkUnknown status
Hospital General Universitari Vall d Hebron
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BarcelonaSpainUnknown status
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainUnknown status
Hospital Universitario HM Sanchinarro
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MadridSpainUnknown status
Hospital Universitario de la Paz
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MadridSpainUnknown status
Hospital Universitario Quirónsalud Madrid
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MadridSpainUnknown status
Hospital Universitario Ramón y Cajal
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MadridSpainUnknown status
Md Anderson Cancer Centre Madrid
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MadridSpainUnknown status
Hgu Gregorio Maranon
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MadridSpainUnknown status
Hospital Universitario de Canarias
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San Cristóbal de La LagunaSpainUnknown status
Hospital Universitario Virgen Macarena
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SevilleSpainUnknown status
Hospital Universitario Virgen del Rocio
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SevilleSpainUnknown status
Birmingham Heartlands Hospital
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BirminghamUnited KingdomUnknown status
Northwick Park Hospital
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LondonUnited KingdomUnknown status
Royal Hallamshire Hospital
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SheffieldUnited KingdomUnknown status
The Royal Marsden Nhs Foundation Trust - Chelsea
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SuttonUnited KingdomUnknown status
Semmelweis Egyetem
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BudapestHungaryUnknown status
National Institute of Oncology
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BudapestHungaryUnknown status
University of Debrecen
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DebrecenHungaryUnknown status
Somogy Medyei Kaposi Mor Oktato Korhaz
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KaposvárHungaryUnknown status
Hillel Yafe Medical Center (Hymc)
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HaderaIsraelUnknown status
Rambam Medical Center
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HaifaIsraelUnknown status
Laniado Hospital Hematology
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NetanyaIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelUnknown status
IRCCS Centro di Riferimento Oncologico
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AvianoItalyUnknown status
Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
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BariItalyUnknown status
University of Bologna
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BolognaItalyUnknown status
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
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MeldolaItalyUnknown status
Ospedale San Raffaele
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MilanItalyUnknown status
Fondazione IRCCS - Istituto Nazionale dei Tumori
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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
I.R.C.C.S. Casa Sollievo Della Sofferenza
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San Giovanni RotondoItalyUnknown status
AOU Città della Salute e della Scienza di Torino
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TorinoItalyUnknown status
San Bartolo Hospital
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VicenzaItalyUnknown status
Uniwersyteckie Centrum Kliniczne
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GdanskPolandUnknown status
Pratia MCM Krakow
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KrakowPolandUnknown status
State Hospital Opole
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OpolePolandUnknown status
Institute of Hematology and Transfusion Medicine
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WarsawPolandUnknown status
Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie
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WarsawPolandUnknown status
Karolinska University Hospital Huddinge
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StockholmSwedenUnknown status
Saint Agnes Hospital
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BaltimoreUnited StatesUnknown status
Beverly Hills Cancer Center
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Beverly HillsUnited StatesUnknown status
Gabrail Cancer Center
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CantonUnited StatesUnknown status
Charleston Hematology Oncology Associates, PA
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CharlestonUnited StatesUnknown status
Barbara Ann Karmanos Cancer Hospital
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DetroitUnited StatesUnknown status
Duke University Medical Center
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DurhamUnited StatesUnknown status
Florida Cancer Specialists & Research Institute
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Fort MyersUnited StatesUnknown status
Hattiesburg Clinic Hematology
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HattiesburgUnited StatesUnknown status
Saint Luke's Hospital
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Kansas CityUnited StatesUnknown status
Sarah Cannon Research Institute
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Kansas CityUnited StatesUnknown status
Clinical Trials of SWLA, LLC
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Lake CharlesUnited StatesUnknown status
Synergy Hematology and Oncology Medical Associates
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Los AngelesUnited StatesUnknown status
Tennessee Oncology
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NashvilleUnited StatesUnknown status
Clinical Research Alliance, Inc.
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New Hyde ParkUnited StatesUnknown status
University of Pennsylvania Health System
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PhiladelphiaUnited StatesUnknown status
Arizona Oncology Associates-Biltmore Cancer Center
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PhoenixUnited StatesUnknown status
St Joseph Heritage Healthcare
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Santa RosaUnited StatesUnknown status
University of Washington
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SeattleUnited StatesUnknown status
Cancer Center of Central Connecticut
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SouthingtonUnited StatesUnknown status
Renovatio Clinical Consultants Llc
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SpringUnited StatesUnknown status
Asclepes Research Centers
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Spring HillUnited StatesUnknown status
American Institute of Research Corporate Office
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WhittierUnited StatesUnknown status

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