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
- Diseases
- Follicular lymphoma
- 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
Sites (83)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St Vincent's Hospital Sydney Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| Western Health Coordinator of this site? Confirm its status | St Albans | Australia | Unknown status |
| Border Medical Oncology Coordinator of this site? Confirm its status | Wodonga | Australia | Unknown status |
| Santa Cabrini Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Saint John Regional Hospital Coordinator of this site? Confirm its status | Saint John | Canada | Unknown status |
| Sunnybrook Health Science Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| University Hospital Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Unknown status |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Unknown status |
| Fakultni nemocnice v Motole Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| University Hospital Kralovkse Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Univerzita Karlova V Praze 1. Lekarska Fakulta Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Bag Arnoldstr. Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| University Medical Center Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Unknown status |
| Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| University Hospital Mannheim Coordinator of this site? Confirm its status | Mannheim | Germany | Unknown status |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Unknown status |
| Odense Universitetshospital (Ouh) (Odense University Hospital) Coordinator of this site? Confirm its status | Odense C | Denmark | Unknown status |
| Hospital General Universitari Vall d Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario de la Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Quirónsalud Madrid Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Md Anderson Cancer Centre Madrid Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hgu Gregorio Maranon Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario de Canarias Coordinator of this site? Confirm its status | San Cristóbal de La Laguna | Spain | Unknown status |
| Hospital Universitario Virgen Macarena Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Birmingham Heartlands Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Northwick Park Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Hallamshire Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| The Royal Marsden Nhs Foundation Trust - Chelsea Coordinator of this site? Confirm its status | Sutton | United Kingdom | Unknown status |
| Semmelweis Egyetem Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| National Institute of Oncology Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Unknown status |
| Somogy Medyei Kaposi Mor Oktato Korhaz Coordinator of this site? Confirm its status | Kaposvár | Hungary | Unknown status |
| Hillel Yafe Medical Center (Hymc) Coordinator of this site? Confirm its status | Hadera | Israel | Unknown status |
| Rambam Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Laniado Hospital Hematology Coordinator of this site? Confirm its status | Netanya | Israel | Unknown status |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| IRCCS Centro di Riferimento Oncologico Coordinator of this site? Confirm its status | Aviano | Italy | Unknown status |
| Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| University of Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Coordinator of this site? Confirm its status | Meldola | Italy | Unknown status |
| Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| A.O.U. Di Modena - Policlinico Coordinator of this site? Confirm its status | Modena | Italy | Unknown status |
| A. O. U. Federico II Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| AOU "Maggiore della Carità" Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
| Ospedali Riuniti Villa Sofia - Cervello Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Sapienza University Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| I.R.C.C.S. Casa Sollievo Della Sofferenza Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Unknown status |
| AOU Città della Salute e della Scienza di Torino Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| San Bartolo Hospital Coordinator of this site? Confirm its status | Vicenza | Italy | Unknown status |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| Pratia MCM Krakow Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| State Hospital Opole Coordinator of this site? Confirm its status | Opole | Poland | Unknown status |
| Institute of Hematology and Transfusion Medicine Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Karolinska University Hospital Huddinge Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Saint Agnes Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Beverly Hills Cancer Center Coordinator of this site? Confirm its status | Beverly Hills | United States | Unknown status |
| Gabrail Cancer Center Coordinator of this site? Confirm its status | Canton | United States | Unknown status |
| Charleston Hematology Oncology Associates, PA Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Barbara Ann Karmanos Cancer Hospital Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Florida Cancer Specialists & Research Institute Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
| Hattiesburg Clinic Hematology Coordinator of this site? Confirm its status | Hattiesburg | United States | Unknown status |
| Saint Luke's Hospital Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Clinical Trials of SWLA, LLC Coordinator of this site? Confirm its status | Lake Charles | United States | Unknown status |
| Synergy Hematology and Oncology Medical Associates Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Tennessee Oncology Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Clinical Research Alliance, Inc. Coordinator of this site? Confirm its status | New Hyde Park | United States | Unknown status |
| University of Pennsylvania Health System Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Arizona Oncology Associates-Biltmore Cancer Center Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| St Joseph Heritage Healthcare Coordinator of this site? Confirm its status | Santa Rosa | United States | Unknown status |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Cancer Center of Central Connecticut Coordinator of this site? Confirm its status | Southington | United States | Unknown status |
| Renovatio Clinical Consultants Llc Coordinator of this site? Confirm its status | Spring | United States | Unknown status |
| Asclepes Research Centers Coordinator of this site? Confirm its status | Spring Hill | United States | Unknown status |
| American Institute of Research Corporate Office Coordinator of this site? Confirm its status | Whittier | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.