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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))

Primary Purpose

Lymphoma

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Parsaclisib
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Mantle cell lymphoma, non-Hodgkin lymphoma, Bruton's tyrosine kinase (BTK), phosphatidylinositol 3-kinase (PI3K)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Alabama At Birmingham Comprehensive Cancer Center
  • St. Joseph Heritage Healthcare
  • Rocky Mountain Cancer Center-Aurora
  • Asclepes Research Centers
  • Moffitt Cancer Center
  • Bond & Steele Clinic, P.A.
  • Rush University Medical Center
  • Loyola University Medical Center
  • Illinois Cancer Specialists
  • Hattiesburg Clinic Hematology
  • Clinical Research Alliance, Inc.
  • Duke University Medical Center
  • Oncology Hematology Care, Inc.
  • Willamette Valley Cancer Institute
  • Kaiser Permanente - Northwest
  • Gettysburg Cancer Center
  • Texas Oncology
  • Texas Oncology San Antonio
  • Renovatio Clinical
  • Texas Oncology - Tyler
  • Yakima Valley Memorial Hospital/North Star
  • Universitair Ziekenhuis Gent
  • Institut Jules Bordet
  • Hopital de Jolimont
  • Universitaire Ziekenhuis Leuven - Gasthuisberg
  • Fakultni Nemocnice Hradec Kralove
  • Fakultni Nemocnice Kralovske Vinohrady
  • Charles University General Hospital
  • Fakultni Nemocnice Kralovske Vinohadry, Interni Hematologicka Klinika
  • Aalborg University Hospital
  • Aarhus Universitets Hospital
  • Odense Universitetshospital (Ouh) (Odense University Hospital)
  • Zealand University Hospital
  • Avicenne Hospital
  • Chu de Clermont - Ferrand- Hospital Estaing
  • Centre Hospitalier Universitaire Henri Mondor
  • University Hospital Grenoble
  • Centre Hospitalier Departemental - La-Roche-Sur-Yon - Les Oudairies
  • Centre Hospitalier Universitaire de Grenoble
  • Centre Hospitalier de Versailles
  • Hospices Civils de Lyon Centre Hospitalier Lyon Sud
  • Centre Antoine Lacassagne
  • Hopital Saint-Louis
  • H�Pital Universitaire Piti�-Salp�Tri�Re
  • Centre Hospitalier Lyon-Sud
  • Centre Hospitalier Universitaire de Poitiers
  • Centre Henri Becquerel
  • Chru Hopitaux de Tours, Hospital Bretonneau
  • Institute Gustave Roussy (Igr)
  • Praxis Brudler, Heinrich, Bangerter
  • Universitaetsklinikum Essen
  • Universit�Tsklinikum Essen
  • Justus-Liebig University
  • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
  • Kliniken Maria Hilf
  • Rotkreuzklinikum Munich
  • Universit�Tsklinikum Ulm
  • Rambam Medical Center
  • Hadassah Hebrew University Medical Center
  • Hadassah Hebrew University Medical Center Ein Karem Hadassah
  • Rabin Medical Center - Beilinson Hospital
  • Tel Aviv Sourasky Medical Center
  • Fondazione Irccs Istituto Nazionale Dei Tumori
  • Centro Ricerche Cliniche
  • Azienda Policlinico Vittorio Emanuele
  • Grande Ospedale Metropolitano Niguarda
  • Ospedale Niguarda Ca Granda
  • A.O.U. Di Modena - Policlinico
  • A.O.U. Federico Ii
  • Aou Maggiore Della Carita
  • Ospedali Riuniti Villa Sofia Cervello
  • Sapienza University
  • Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
  • Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza
  • Beskidzkie Centrum Onkologii Im.Jana Pawla Ii
  • Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
  • University Clinical Center
  • Pratia McM Krakow
  • Nu-Med Centrum Diagnostykii I Terapii Onkologicznej
  • Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie
  • Hospital Del Mar
  • Hospital General Universitari Vall D Hebron
  • Hospital Universitari Mutua Terrassa
  • Institut Catala D Oncologia
  • Hospital Universitario de Burgos
  • Hospital General Universitario Gregorio Maranon
  • Md Anderson Cancer Centre Madrid
  • Hospital Universitario Ramon Y Cajal
  • Fundacion Jimenez Diaz University Hospital
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario de La Paz
  • Hospital General Universitario Morales Meseguer
  • Complejo Hospitalario de Navarra
  • Hospital Clinico Universitario de Salamanca
  • Hospital Universitario Virgen del Rocio
  • Hospital Arnau de Vilanova
  • Hospital Universitario Dr. Peset
  • Hospital Universitario Y Politecnic La Fe
  • Birmingham Heartlands Hospital
  • Western General Hospital
  • University College London Hospitals (Uclh)
  • Derriford Hospital
  • Royal Hallamshire Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1: Treatment A (Exposed to Ibrutinib)

Cohort 1: Treatment B (Exposed to Ibrutinib)

Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve)

Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve)

Arm Description

Participants 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.

Participants 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.

Participants 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.

Participants 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Duration of Response (DOR)
DOR=time from first documented evidence of CR or PR until disease progression or death from any cause among participants who achieve an objective response as determined by IRC. Criteria for CR: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative. The criteria for PR included: 1.Lymph nodes and extralymphatic sites- a. ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; b. when a lesion is too small to measure on CT, assign 5 mm×5 mm as the default; c.when no longer visible, 0×0 mm. For a node >5 mm×5 mm but smaller than normal, use actual measurement. 2.Non-measured lesions- Absent/regressed, but no increase. 3. Organ enlargement-Spleen must have regressed by >50% in length beyond normal. 4.No new lesions.
Complete Response Rate (CRR)
CRR is defined as the percentage of participants with a CR as defined by response criteria for lymphomas, as determined by an IRC. The criteria for CR included: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative.
Progression-Free Survival (PFS)
PFS is defined as the time from the date of the first dose of study treatment until the earliest date of disease progression as determined by radiographic disease assessment provided by an IRC, or death from any cause.
Overall Survival (OS)
OS is defined as the time from the date of the first dose of study treatment until death from any cause.
Best Percent Change From Baseline in Target Lesion Size
Target lesion size is measured by the sum of the product of diameters of all target lesion sizes and is determined by the IRC. The best percent change from Baseline is defined as the largest decrease, or smallest increase if no decrease available, from Baseline in target lesion sizes on/before new (next-line) anti-lymphoma therapy during the study. Baseline is the last nonmissing measurement obtained before the first administration of study drug. A negative percent change from Baseline indicates improvement.
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug regardless of starting new anti-lymphoma therapy. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is considered to be an important medical event that may not result in death, be immediately life-threatening, or require hospitalization but may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant or may require medical or surgical intervention.

Full Information

First Posted
July 27, 2017
Last Updated
June 16, 2023
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03235544
Brief Title
A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor
Acronym
(CITADEL-205)
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 20, 2017 (Actual)
Primary Completion Date
March 3, 2021 (Actual)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Mantle cell lymphoma, non-Hodgkin lymphoma, Bruton's tyrosine kinase (BTK), phosphatidylinositol 3-kinase (PI3K)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: Treatment A (Exposed to Ibrutinib)
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Cohort 1: Treatment B (Exposed to Ibrutinib)
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve)
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve)
Arm Type
Experimental
Arm Description
Participants 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.
Intervention Type
Drug
Intervention Name(s)
Parsaclisib
Other Intervention Name(s)
INCB050465
Intervention Description
Parsaclisib tablets administered orally with water and without regard to food.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
Up to approximately 165 weeks
Secondary Outcome Measure Information:
Title
Duration of Response (DOR)
Description
DOR=time from first documented evidence of CR or PR until disease progression or death from any cause among participants who achieve an objective response as determined by IRC. Criteria for CR: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative. The criteria for PR included: 1.Lymph nodes and extralymphatic sites- a. ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; b. when a lesion is too small to measure on CT, assign 5 mm×5 mm as the default; c.when no longer visible, 0×0 mm. For a node >5 mm×5 mm but smaller than normal, use actual measurement. 2.Non-measured lesions- Absent/regressed, but no increase. 3. Organ enlargement-Spleen must have regressed by >50% in length beyond normal. 4.No new lesions.
Time Frame
Up to approximately 165 weeks
Title
Complete Response Rate (CRR)
Description
CRR is defined as the percentage of participants with a CR as defined by response criteria for lymphomas, as determined by an IRC. The criteria for CR included: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative.
Time Frame
Up to approximately 165 weeks
Title
Progression-Free Survival (PFS)
Description
PFS is defined as the time from the date of the first dose of study treatment until the earliest date of disease progression as determined by radiographic disease assessment provided by an IRC, or death from any cause.
Time Frame
Up to approximately 165 weeks
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of the first dose of study treatment until death from any cause.
Time Frame
Up to approximately 165 weeks
Title
Best Percent Change From Baseline in Target Lesion Size
Description
Target lesion size is measured by the sum of the product of diameters of all target lesion sizes and is determined by the IRC. The best percent change from Baseline is defined as the largest decrease, or smallest increase if no decrease available, from Baseline in target lesion sizes on/before new (next-line) anti-lymphoma therapy during the study. Baseline is the last nonmissing measurement obtained before the first administration of study drug. A negative percent change from Baseline indicates improvement.
Time Frame
Up to approximately 165 weeks
Title
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
An adverse event (AE) is any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug regardless of starting new anti-lymphoma therapy. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is considered to be an important medical event that may not result in death, be immediately life-threatening, or require hospitalization but may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant or may require medical or surgical intervention.
Time Frame
From first dose of study drug up to approximately 165 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fred Zheng, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama At Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
St. Joseph Heritage Healthcare
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Rocky Mountain Cancer Center-Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Asclepes Research Centers
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33647
Country
United States
Facility Name
Bond & Steele Clinic, P.A.
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Illinois Cancer Specialists
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Hattiesburg Clinic Hematology
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Clinical Research Alliance, Inc.
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45230
Country
United States
Facility Name
Willamette Valley Cancer Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Kaiser Permanente - Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Gettysburg Cancer Center
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Facility Name
Texas Oncology
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Oncology San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Renovatio Clinical
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Texas Oncology - Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Yakima Valley Memorial Hospital/North Star
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
Universitair Ziekenhuis Gent
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Institut Jules Bordet
City
Brussels
Country
Belgium
Facility Name
Hopital de Jolimont
City
La Louviere
ZIP/Postal Code
07100
Country
Belgium
Facility Name
Universitaire Ziekenhuis Leuven - Gasthuisberg
City
Leuven
ZIP/Postal Code
03000
Country
Belgium
Facility Name
Fakultni Nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni Nemocnice Kralovske Vinohrady
City
Prague 10
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Charles University General Hospital
City
Prague 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Fakultni Nemocnice Kralovske Vinohadry, Interni Hematologicka Klinika
City
Prague
ZIP/Postal Code
10034
Country
Czechia
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
09000
Country
Denmark
Facility Name
Aarhus Universitets Hospital
City
Aarhus
ZIP/Postal Code
DK-8000
Country
Denmark
Facility Name
Odense Universitetshospital (Ouh) (Odense University Hospital)
City
Odense C
ZIP/Postal Code
05000
Country
Denmark
Facility Name
Zealand University Hospital
City
Roskilde
ZIP/Postal Code
04000
Country
Denmark
Facility Name
Avicenne Hospital
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Chu de Clermont - Ferrand- Hospital Estaing
City
Clermont-ferrand
ZIP/Postal Code
63230
Country
France
Facility Name
Centre Hospitalier Universitaire Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
University Hospital Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Centre Hospitalier Departemental - La-Roche-Sur-Yon - Les Oudairies
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Centre Hospitalier Universitaire de Grenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Centre Hospitalier de Versailles
City
Le Chesnay
ZIP/Postal Code
78157
Country
France
Facility Name
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
H�Pital Universitaire Piti�-Salp�Tri�Re
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Centre Hospitalier Lyon-Sud
City
Pierre-Bénite Cedex
ZIP/Postal Code
69310
Country
France
Facility Name
Centre Hospitalier Universitaire de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Chru Hopitaux de Tours, Hospital Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Institute Gustave Roussy (Igr)
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Praxis Brudler, Heinrich, Bangerter
City
Augsburg
ZIP/Postal Code
86150
Country
Germany
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Universit�Tsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Justus-Liebig University
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Kliniken Maria Hilf
City
Moenchengladbach
ZIP/Postal Code
41063
Country
Germany
Facility Name
Rotkreuzklinikum Munich
City
Munchen
ZIP/Postal Code
80634
Country
Germany
Facility Name
Universit�Tsklinikum Ulm
City
ULM
ZIP/Postal Code
89081
Country
Germany
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah Hebrew University Medical Center
City
Jerusalem
ZIP/Postal Code
90000
Country
Israel
Facility Name
Hadassah Hebrew University Medical Center Ein Karem Hadassah
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin Medical Center - Beilinson Hospital
City
Petach Tikva
ZIP/Postal Code
4841492
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Fondazione Irccs Istituto Nazionale Dei Tumori
City
Milano
State/Province
MI
ZIP/Postal Code
20133
Country
Italy
Facility Name
Centro Ricerche Cliniche
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Policlinico Vittorio Emanuele
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Ospedale Niguarda Ca Granda
City
Milano
ZIP/Postal Code
22162
Country
Italy
Facility Name
A.O.U. Di Modena - Policlinico
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
A.O.U. Federico Ii
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Aou Maggiore Della Carita
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Ospedali Riuniti Villa Sofia Cervello
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Sapienza University
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Beskidzkie Centrum Onkologii Im.Jana Pawla Ii
City
Bielsko-biala
ZIP/Postal Code
43-300
Country
Poland
Facility Name
Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
City
Brzozow
ZIP/Postal Code
36-200
Country
Poland
Facility Name
University Clinical Center
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Pratia McM Krakow
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Nu-Med Centrum Diagnostykii I Terapii Onkologicznej
City
Tomaszow Mazowiecki
ZIP/Postal Code
97-200
Country
Poland
Facility Name
Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Hospital Del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital General Universitari Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitari Mutua Terrassa
City
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
Institut Catala D Oncologia
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario de Burgos
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Md Anderson Cancer Centre Madrid
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Universitario Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Fundacion Jimenez Diaz University Hospital
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario de La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital General Universitario Morales Meseguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Clinico Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41005
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Hospital Universitario Dr. Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Hospital Universitario Y Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
University College London Hospitals (Uclh)
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing 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.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency

Learn more about this trial

A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor

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