A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor
(CITADEL-205)
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)
3 other identifiers
interventional
162
11 countries
103
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 lymphoma
Started Nov 2017
Typical duration for phase_2 lymphoma
103 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2017
CompletedFirst Posted
Study publicly available on registry
August 1, 2017
CompletedStudy Start
First participant enrolled
November 20, 2017
CompletedResults Posted
Study results publicly available
February 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedMarch 18, 2025
February 1, 2025
6.4 years
July 27, 2017
January 14, 2022
February 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
ORR=percentage of participants with complete response(CR) or partial response(PR) per revised response criteria for lymphomas,determined by independent review committee(IRC).Criteria for CR:1.Target nodes/nodal masses of lymph nodes,extralymphatic sites regressed to≤1.5cm in longest dimension transverse diameter of lesion(LDi);2.Absence of non-measured lesion;3.Organ enlargement regressed to normal;4.No new lesions;5.Normal bone marrow morphology;if indeterminate,immunohistochemistry negative.Criteria for PR:1.Lymph nodes,extralymphatic sites- ≥50%decrease in sum of product of perpendicular diameters for multiple lesions(SPD)of up to 6 target measurable nodes,extranodal sites;if lesion is too small to measure on computed tomography(CT),assign5mm×5mm as default;if no longer visible,0×0mm.Node\>5mm×5mm but smaller than normal,use actual measurement.2.Absent/regressed non-measured lesions,no increase.3.Organ enlargement-Spleen regressed by\>50%in length beyond normal.4.No new lesions.
Up to 1016 days
Secondary Outcomes (6)
Duration of Response (DOR)
Up to 1016 days
Complete Response Rate (CRR)
Up to 1016 days
Progression-Free Survival (PFS)
Up to 1016 days
Overall Survival (OS)
Up to 2017 days
Best Percent Change From Baseline in Target Lesion Size
Up to 1016 days
- +1 more secondary outcomes
Study Arms (4)
Cohort 1: Treatment A (Exposed to Ibrutinib)
EXPERIMENTALParticipants received parsaclisib 20 mg tablets, orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
Cohort 1: Treatment B (Exposed to Ibrutinib)
EXPERIMENTALParticipants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve)
EXPERIMENTALParticipants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who had not received a BTK inhibitor previously were included in this group.
Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve)
EXPERIMENTALParticipants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who had not received a BTK inhibitor previously were included in this group.
Interventions
Parsaclisib tablets administered orally with water and without regard to food.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- History of central nervous system lymphoma (either primary or metastatic).
- 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.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (103)
University of Alabama At Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35205, United States
St. Joseph Heritage Healthcare
Santa Rosa, California, 95403, United States
Rocky Mountain Cancer Center-Aurora
Aurora, Colorado, 80012, United States
Asclepes Research Centers
Brooksville, Florida, 34613, United States
Moffitt Cancer Center
Tampa, Florida, 33647, United States
Bond & Steele Clinic, P.A.
Winter Haven, Florida, 33880, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Illinois Cancer Specialists
Niles, Illinois, 60714, United States
Hattiesburg Clinic Hematology
Hattiesburg, Mississippi, 39401, United States
Clinical Research Alliance, Inc.
New Hyde Park, New York, 11042, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45230, United States
Willamette Valley Cancer Institute
Eugene, Oregon, 97401, United States
Kaiser Permanente - Northwest
Portland, Oregon, 97227, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325, United States
Texas Oncology
Austin, Texas, 78705, United States
Texas Oncology San Antonio
San Antonio, Texas, 78240, United States
Renovatio Clinical
The Woodlands, Texas, 77380, United States
Texas Oncology - Tyler
Tyler, Texas, 75702, United States
Yakima Valley Memorial Hospital/North Star
Yakima, Washington, 98902, United States
Universitair Ziekenhuis Gent
Ghent, Oost-Vlaanderen, 9000, Belgium
Institut Jules Bordet
Brussels, Belgium
Hopital de Jolimont
La Louvière, 07100, Belgium
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven, 03000, Belgium
Fakultni Nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Fakultni Nemocnice Kralovske Vinohadry, Interni Hematologicka Klinika
Prague, 10034, Czechia
Charles University General Hospital
Prague, 128 08, Czechia
Fakultni Nemocnice Kralovske Vinohrady
Prague, 500 05, Czechia
Aalborg University Hospital
Aalborg, 09000, Denmark
Aarhus Universitets Hospital
Aarhus, DK-8000, Denmark
Odense Universitetshospital (Ouh) (Odense University Hospital)
Odense C, 05000, Denmark
Zealand University Hospital
Roskilde, 04000, Denmark
Avicenne Hospital
Bobigny, 93000, France
Chu de Clermont - Ferrand- Hospital Estaing
Clermont-Ferrand, 63230, France
Centre Hospitalier Universitaire Henri Mondor
Créteil, 94010, France
University Hospital Grenoble
Grenoble, 38043, France
Centre Hospitalier Departemental - La-Roche-Sur-Yon - Les Oudairies
La Roche-sur-Yon, 85925, France
Centre Hospitalier Universitaire de Grenoble
La Tronche, 38700, France
Centre Hospitalier de Versailles
Le Chesnay, 78157, France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
Lyon, 69008, France
Centre Antoine Lacassagne
Nice, 06189, France
Hopital Saint-Louis
Paris, 75010, France
H�Pital Universitaire Piti�-Salp�Tri�Re
Paris, 75013, France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69310, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021, France
Centre Henri Becquerel
Rouen, 76038, France
Chru Hopitaux de Tours, Hospital Bretonneau
Tours, 37044, France
Institute Gustave Roussy (Igr)
Villejuif, 94805, France
Praxis Brudler, Heinrich, Bangerter
Augsburg, 86150, Germany
Universitaetsklinikum Essen
Essen, 45122, Germany
Universit�Tsklinikum Essen
Essen, 45147, Germany
Justus-Liebig University
Giessen, 35392, Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, 55131, Germany
Kliniken Maria Hilf
Mönchengladbach, 41063, Germany
Rotkreuzklinikum Munich
München, 80634, Germany
Universit�Tsklinikum Ulm
Ulm, 89081, Germany
Rambam Medical Center
Haifa, 31096, Israel
Hadassah Hebrew University Medical Center
Jerusalem, 90000, Israel
Hadassah Hebrew University Medical Center Ein Karem Hadassah
Jerusalem, 91120, Israel
Rabin Medical Center - Beilinson Hospital
Petah Tikva, 4841492, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, MI, 20133, Italy
Centro Ricerche Cliniche
Bologna, 40138, Italy
Azienda Policlinico Vittorio Emanuele
Catania, 95123, Italy
Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Ospedale Niguarda Ca Granda
Milan, 22162, Italy
A.O.U. Di Modena - Policlinico
Modena, 41124, Italy
A.O.U. Federico Ii
Napoli, 80131, Italy
Aou Maggiore Della Carita
Novara, 28100, Italy
Ospedali Riuniti Villa Sofia Cervello
Palermo, 90146, Italy
Sapienza University
Rome, 00161, Italy
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
Siena, 53100, Italy
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza
Torino, 10126, Italy
Beskidzkie Centrum Onkologii Im.Jana Pawla Ii
Bielsko-Biala, 43-300, Poland
Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Brzozów, 36-200, Poland
University Clinical Center
Gdansk, 80-952, Poland
Pratia McM Krakow
Krakow, 30-510, Poland
Nu-Med Centrum Diagnostykii I Terapii Onkologicznej
Tomaszów Mazowiecki, 97-200, Poland
Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie
Warsaw, 02-781, Poland
Hospital Del Mar
Barcelona, 08003, Spain
Hospital General Universitari Vall D Hebron
Barcelona, 08035, Spain
Hospital Universitari Mutua Terrassa
Barcelona, 08221, Spain
Institut Catala D Oncologia
Barcelona, 08916, Spain
Hospital Universitario de Burgos
Burgos, 09006, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Md Anderson Cancer Centre Madrid
Madrid, 28033, Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034, Spain
Fundacion Jimenez Diaz University Hospital
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario de La Paz
Madrid, 28046, Spain
Hospital General Universitario Morales Meseguer
Murcia, 30008, Spain
Complejo Hospitalario de Navarra
Pamplona, 31008, Spain
Hospital Clinico Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Virgen del Rocio
Seville, 41005, Spain
Hospital Arnau de Vilanova
Valencia, 46015, Spain
Hospital Universitario Dr. Peset
Valencia, 46017, Spain
Hospital Universitario Y Politecnic La Fe
Valencia, 46026, Spain
Birmingham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
University College London Hospitals (Uclh)
London, NW1 2PG, United Kingdom
Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
Royal Hallamshire Hospital
Sheffield, S10 2JF, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Incyte Corporation
Study Officials
- STUDY DIRECTOR
Fred Zheng, MD
Incyte Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2017
First Posted
August 1, 2017
Study Start
November 20, 2017
Primary Completion
April 30, 2024
Study Completion
April 30, 2024
Last Updated
March 18, 2025
Results First Posted
February 10, 2022
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
- Access Criteria
- Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
Individual participant data (IPD) will be made available to interested researchers after the end of study, a thorough analysis, and the publication of the data in the clinical study report (CSR). As required, results of the data will be posted to ClinicalTrials.gov. Upon request, individual investigators may obtain IPD from the sponsor. The format for data delivery will be determined between sponsor and investigator.