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
- Diseases
- Mantle cell lymphoma
- 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
Sites (103)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Jules Bordet Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| Hôpital de Jolimont Coordinator of this site? Confirm its status | La Louvière | Belgium | Unknown status |
| Universitaire Ziekenhuis Leuven - Gasthuisberg Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Fakultni nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Unknown status |
| Charles University General Hospital Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Fakultni nemocnice Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Fakultni Nemocnice Kralovske Vinohadry, Interni Hematologicka Klinika Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Praxis Brudler, Heinrich, Bangerter Coordinator of this site? Confirm its status | Augsburg | Germany | Unknown status |
| Universitaetsklinikum - Essen Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Universit�Tsklinikum Essen Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Justus-Liebig University Coordinator of this site? Confirm its status | Giessen | Germany | Unknown status |
| Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Kliniken Maria Hilf Coordinator of this site? Confirm its status | Mönchengladbach | Germany | Unknown status |
| Rotkreuzklinikum Munich Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Universit�Tsklinikum Ulm Coordinator of this site? Confirm its status | Ulm | Germany | Unknown status |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Unknown status |
| Aarhus Universitets Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Odense Universitetshospital (Ouh) (Odense University Hospital) Coordinator of this site? Confirm its status | Odense C | Denmark | Unknown status |
| Zealand University Hospital Coordinator of this site? Confirm its status | Roskilde | Denmark | Unknown status |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitari Mutua Terrassa Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital General Universitari Vall d Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario De Burgos Coordinator of this site? Confirm its status | Burgos | Spain | Unknown status |
| Hospital Universitario de la Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Fundación Jiménez Díaz University Hospital 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 |
| Hospital Universitario 12 de Octubre 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 |
| Hospital General Universitario Morales Meseguer Coordinator of this site? Confirm its status | Murcia | Spain | Unknown status |
| Complejo Hospitalario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Hospital Clinico Universitario de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Universitario Y Politecnic La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Universitario Dr. Peset Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Arnau de Vilanova Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Avicenne Hospital Coordinator of this site? Confirm its status | Bobigny | France | Unknown status |
| Chu de Clermont - Ferrand- Hospital Estaing Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Centre Hospitalier Universitaire Henri Mondor Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
| university Hospital Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Centre Hospitalier Departemental - La-Roche-Sur-Yon - Les Oudairies Coordinator of this site? Confirm its status | La Roche-sur-Yon | France | Unknown status |
| Centre Hospitalier Universitaire de Grenoble Coordinator of this site? Confirm its status | La Tronche | France | Unknown status |
| Centre Hospitalier de Versailles Coordinator of this site? Confirm its status | Le Chesnay | France | Unknown status |
| Hospices Civils de Lyon Centre Hospitalier Lyon Sud Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| H�Pital Universitaire Piti�-Salp�Tri�Re Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Centre Hospitalier Lyon-Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Unknown status |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| Centre Henri Becquerel Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Chru Hopitaux de Tours Hospital Bretonneau Coordinator of this site? Confirm its status | Tours | France | Unknown status |
| Institute Gustave Roussy (Igr) Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
| Birmingham Heartlands Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Western General Hospital Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| University College London Hospitals (UCLH) Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Derriford Hospital Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| Royal Hallamshire Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| Rambam Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah Hebrew University Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Hadassah Hebrew University Medical Center Ein Karem Hadassah Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Rabin Medical Center- Beilinson Hospital Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Centro Ricerche Cliniche Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Azienda Policlinico Vittorio Emanuele Coordinator of this site? Confirm its status | Catania | Italy | Unknown status |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Ospedale Niguarda Ca Granda Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Grande Ospedale Metropolitano Niguarda 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 |
| Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte Coordinator of this site? Confirm its status | Siena | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Città della salute e della Scienza Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Beskidzkie Centrum Onkologii im. Jana Pawla II Coordinator of this site? Confirm its status | Bielsko-Biala | Poland | Unknown status |
| Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Coordinator of this site? Confirm its status | Brzozów | Poland | Unknown status |
| University Clinical Center 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 |
| Nu-Med Centrum Diagnostykii I Terapii Onkologicznej Coordinator of this site? Confirm its status | Tomaszów Mazowiecki | Poland | Unknown status |
| Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Rocky Mountain Cancer Center - Aurora Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Texas Oncology Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| University of Alabama at Birmingham, Comprehensive Cancer Center Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| ASCLEPES Research Centers Coordinator of this site? Confirm its status | Brooksville | United States | Unknown status |
| Rush University Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Oncology Hematology Care, Inc Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Willamette Valley Cancer Institute Coordinator of this site? Confirm its status | Eugene | United States | Unknown status |
| Gettysburg Cancer Center Coordinator of this site? Confirm its status | Gettysburg | United States | Unknown status |
| Hattiesburg Clinic Hematology Coordinator of this site? Confirm its status | Hattiesburg | United States | Unknown status |
| Loyola University Medical Center Coordinator of this site? Confirm its status | Maywood | United States | Unknown status |
| Clinical Research Alliance, Inc. Coordinator of this site? Confirm its status | New Hyde Park | United States | Unknown status |
| Illinois Cancer Specialists Coordinator of this site? Confirm its status | Niles | United States | Unknown status |
| Kaiser Permanente Northwest Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Texas Oncology - San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| St Joseph Heritage Healthcare Coordinator of this site? Confirm its status | Santa Rosa | United States | Unknown status |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Renovatio Clinical Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| Texas Oncology - Tyler Coordinator of this site? Confirm its status | Tyler | United States | Unknown status |
| Bond & Steele Clinic, P.A. Coordinator of this site? Confirm its status | Winter Haven | United States | Unknown status |
| Yakima Valley Memorial Hospital/North Star Coordinator of this site? Confirm its status | Yakima | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.