Clinical trial NCT03235544: A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: Mantle cell lymphoma
non-Hodgkin lymphoma
Bruton's tyrosine kinase (BTK)
phosphatidylinositol 3-kinase (PI3K)
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2017-08-01
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 1016 days
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: Up to 1016 days
measure: Complete Response Rate (CRR)
timeFrame: Up to 1016 days
measure: Progression-Free Survival (PFS)
timeFrame: Up to 1016 days
measure: Overall Survival (OS)
timeFrame: Up to 2017 days
measure: Best Percent Change From Baseline in Target Lesion Size
timeFrame: Up to 1016 days
measure: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: From first dose of study drug up to 2045 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama At Birmingham Comprehensive Cancer Center
state: Alabama
city: Santa Rosa
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Center-Aurora
state: Colorado
city: Brooksville
country: United States
facility: Asclepes Research Centers
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Winter Haven
country: United States
facility: Bond & Steele Clinic, P.A.
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Niles
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic Hematology
state: Mississippi
city: New Hyde Park
country: United States
facility: Clinical Research Alliance, Inc.
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc.
state: Ohio
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute
state: Oregon
city: Portland
country: United States
facility: Kaiser Permanente - Northwest
state: Oregon
city: Gettysburg
country: United States
facility: Gettysburg Cancer Center
state: Pennsylvania
city: Austin
country: United States
facility: Texas Oncology
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology San Antonio
state: Texas
city: The Woodlands
country: United States
facility: Renovatio Clinical
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Tyler
state: Texas
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital/North Star
state: Washington
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
state: Oost-Vlaanderen
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: La Louviere
country: Belgium
facility: Hopital de Jolimont
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuis Leuven - Gasthuisberg
city: Hradec Kralove
country: Czechia
facility: Fakultni Nemocnice Hradec Kralove
city: Prague 10
country: Czechia
facility: Fakultni Nemocnice Kralovske Vinohrady
city: Prague 2
country: Czechia
facility: Charles University General Hospital
city: Prague
country: Czechia
facility: Fakultni Nemocnice Kralovske Vinohadry, Interni Hematologicka Klinika
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus Universitets Hospital
city: Odense C
country: Denmark
facility: Odense Universitetshospital (Ouh) (Odense University Hospital)
city: Roskilde
country: Denmark
facility: Zealand University Hospital
city: Bobigny
country: France
facility: Avicenne Hospital
city: Clermont-ferrand
country: France
facility: Chu de Clermont - Ferrand- Hospital Estaing
city: Creteil
country: France
facility: Centre Hospitalier Universitaire Henri Mondor
city: Grenoble
country: France
facility: University Hospital Grenoble
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Departemental - La-Roche-Sur-Yon - Les Oudairies
city: La Tronche
country: France
facility: Centre Hospitalier Universitaire de Grenoble
city: Le Chesnay
country: France
facility: Centre Hospitalier de Versailles
city: Lyon
country: France
facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Hopital Saint-Louis
city: Paris
country: France
facility: H�Pital Universitaire Piti�-Salp�Tri�Re
city: Pierre-Bénite Cedex
country: France
facility: Centre Hospitalier Lyon-Sud
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Tours
country: France
facility: Chru Hopitaux de Tours, Hospital Bretonneau
city: Villejuif Cedex
country: France
facility: Institute Gustave Roussy (Igr)
city: Augsburg
country: Germany
facility: Praxis Brudler, Heinrich, Bangerter
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Essen
country: Germany
facility: Universit�Tsklinikum Essen
city: Giessen
country: Germany
facility: Justus-Liebig University
city: Mainz
country: Germany
facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
city: Moenchengladbach
country: Germany
facility: Kliniken Maria Hilf
city: Munchen
country: Germany
facility: Rotkreuzklinikum Munich
city: ULM
country: Germany
facility: Universit�Tsklinikum Ulm
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Medical Center Ein Karem Hadassah
city: Petach Tikva
country: Israel
facility: Rabin Medical Center - Beilinson Hospital
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Milano
country: Italy
facility: Fondazione Irccs Istituto Nazionale Dei Tumori
state: MI
city: Bologna
country: Italy
facility: Centro Ricerche Cliniche
city: Catania
country: Italy
facility: Azienda Policlinico Vittorio Emanuele
city: Milano
country: Italy
facility: Grande Ospedale Metropolitano Niguarda
city: Milano
country: Italy
facility: Ospedale Niguarda Ca Granda
city: Modena
country: Italy
facility: A.O.U. Di Modena - Policlinico
city: Napoli
country: Italy
facility: A.O.U. Federico Ii
city: Novara
country: Italy
facility: Aou Maggiore Della Carita
city: Palermo
country: Italy
facility: Ospedali Riuniti Villa Sofia Cervello
city: Rome
country: Italy
facility: Sapienza University
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
city: Torino
country: Italy
facility: Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza
city: Bielsko-biala
country: Poland
facility: Beskidzkie Centrum Onkologii Im.Jana Pawla Ii
city: Brzozow
country: Poland
facility: Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
city: Gdansk
country: Poland
facility: University Clinical Center
city: Krakow
country: Poland
facility: Pratia McM Krakow
city: Tomaszow Mazowiecki
country: Poland
facility: Nu-Med Centrum Diagnostykii I Terapii Onkologicznej
city: Warszawa
country: Poland
facility: Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Barcelona
country: Spain
facility: Hospital General Universitari Vall D Hebron
city: Barcelona
country: Spain
facility: Hospital Universitari Mutua Terrassa
city: Barcelona
country: Spain
facility: Institut Catala D Oncologia
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Md Anderson Cancer Centre Madrid
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz University Hospital
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario de La Paz
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
city: Valencia
country: Spain
facility: Hospital Universitario Y Politecnic La Fe
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: London
country: United Kingdom
facility: University College London Hospitals (Uclh)
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
Study officials:
affiliation: Incyte Corporation
name: Fred Zheng, MD
role: STUDY_DIRECTOR
References: