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A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)

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 Marginal zone lymphoma, phosphatidylinositol 3-kinase (PI3K)δ inhibitor, indolent (slow-growing) non-Hodgkin lymphoma B-cell lymphoma

Eligibility Criteria

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

Inclusion Criteria:

  • Men and women, aged 18 or older (except in South Korea, aged 19 or older).
  • Histologically confirmed marginal zone lymphoma, including extranodal, nodal, and splenic subtypes.
  • Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest transverse diameter and ≥ 1.0 cm in the longest perpendicular diameter.
  • Participants with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed.
  • Participants must be willing to undergo an incisional or excisional lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
  • Eastern Cooperative Oncology Group performance status 0 to 2.

Exclusion Criteria:

  • Evidence of diffuse large B-cell transformation.
  • History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
  • Prior treatment with idelalisib, other selective 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 the first dose of study treatment.
  • Active graft versus host disease.
  • Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.

Sites / Locations

  • University of Alabama At Birmingham Comprehensive Cancer Center
  • Arizona Oncology Associates
  • Torrance Health Association
  • Sansum Clinic
  • Central Coast Medical Oncology
  • UCLA Healthcare Hematology-Oncology
  • St. Joseph Heritage Healthcare
  • Innovative Clinical Research Institute
  • Loyola University Medical Center
  • Valley View Hospital
  • St. Mary'S Hospital Regional Cancer Center
  • University of Miami Sylvester Comprehensive Cancer Center
  • Advanced Pharma Cr
  • Boca Raton Clinical Research Medical Inc.
  • Asclepes Research Centers
  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University
  • Rush University Medical Center - Consultants in Hematology
  • Clinical Trials of Swla Llc
  • University of Michigan Cancer Center
  • Henry Ford Health System
  • Saint Luke'S Hospital of Kansas City
  • COMPREHENSIVE CANCER CeNTERS OF NEVADA - TWAIN
  • Clinical Research Alliance
  • Nyu Cancer Institute
  • Hematology Oncology Associates of Rockland
  • White Plains Hospital
  • Duke University Medical Center
  • Gabrail Cancer Center
  • Gettysburg Cancer Center
  • Charleston Hematology Oncology Associates Pa
  • Renovatio Clinical
  • University of Washington - Seattle Cancer Care Alliance
  • Medical College of Wisconsin
  • Aou Maggiore Della Carita
  • Icon Cancer Care
  • Royal Adelaide Hospital
  • Calvary North Adelaide Hospital
  • Cliniques Universitaires Ucl Saint-Luc
  • Universitair Ziekenhuis Gent
  • Universitaire Ziekenhuis Leuven - Gasthuisberg
  • Aalborg University Hospital
  • Zealand University Hospital
  • Avicenne Hospital
  • Centre Hospitalier Universitaire Henri Mondor
  • Chu Limoges - H�Pital Le Cluzeau
  • Hopital Saint-Louis
  • H�Pital Universitaire Piti�-Salp�Tri�Re
  • Hospices Civils de Lyon Centre Hospitalier Lyon Sud
  • Centre Henri Becquerel
  • Institute Gustave Roussy (Igr)
  • Universit�Tsklinikum Essen
  • Universitatsmedizin Gottingen
  • Universit�Tsklinikum Schleswig-Holstein
  • Klinikum Ludwigshafen
  • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
  • Universit�Tsklinikum Ulm
  • Rambam Medical Center
  • Hadassah Hebrew University Medical Center Ein Karem Hadassah
  • Rabin Medical Center - Beilinson Hospital
  • Chaim Sheba Medical Center
  • Tel Aviv Sourasky Medical Center
  • University of Bologna, Institute of Haematology �L. E A. Ser�Gnoli�
  • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
  • Fondazione Centro San Raffaele - Milano
  • Fondazione Irccs Istituto Nazionale Dei Tumori
  • Azienda Ospedaliera San Gerardo Di Monza
  • Azienda Ospedaliera Ospedali Riuniti "Villa Sofia - Cervello"
  • Presidio Ospedaliero Pescara
  • Ospedale Delle Croci - Ematologia Ravenna
  • Sapienza University
  • Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie
  • Szpitale Wojew�Dzkie W Gdyni Sp�?Ka Z Ograniczon? Odpowiedzialno?Ci?
  • Malopolskie Centrum Medyczne S.C.
  • Klinika Transplantacji Komorel Krwiotworczych
  • Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie
  • Hospital General Universitari Vall D Hebron
  • Ico Institut Catala D Oncologia
  • Hgu Gregorio Maranon
  • Hospital Universitario Hm Sanchinarro
  • Hospital Universitario Quironsalud Madrid
  • Hospital Puerta de Hierro
  • Hospital Universitario de Salamanca
  • Birmingham Heartlands Hospital
  • Kent Oncology Centre - Maidstone Hospital
  • Norfolk and Norwich University Hospital
  • University of Southampton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1- Closed to Further enrollment

Cohort 2

Arm Description

Participants who have received prior ibrutinib.

Participants who have not received a prior BTK inhibitor.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) Based on Lugano Classification Criteria
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),assign 5mm×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) Based on Lugano Classification Criteria
CRR is defined as the percentage of participants with a CR 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
May 5, 2017
Last Updated
May 19, 2023
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03144674
Brief Title
A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)
Official Title
A Phase 2, Open-Label, 2-Cohort Study of INCB050465, a PI3Kδ Inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma With or Without Prior Exposure to a BTK Inhibitor (CITADEL-204)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 18, 2017 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
December 29, 2023 (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
The purpose of this study is to evaluate the safety and efficacy of two parsaclisib treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL) who are naive to or were previously treated with 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
Marginal zone lymphoma, phosphatidylinositol 3-kinase (PI3K)δ inhibitor, indolent (slow-growing) non-Hodgkin lymphoma B-cell lymphoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Cohort 1- Closed to Further enrollment
Arm Type
Experimental
Arm Description
Participants who have received prior ibrutinib.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Participants who have not received a prior BTK inhibitor.
Intervention Type
Drug
Intervention Name(s)
Parsaclisib
Other Intervention Name(s)
INCB050465
Intervention Description
Parsaclisib at the protocol-defined dose.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) Based on Lugano Classification Criteria
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),assign 5mm×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 161 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 161 weeks
Title
Complete Response Rate (CRR) Based on Lugano Classification Criteria
Description
CRR is defined as the percentage of participants with a CR 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 161 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 161 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 161 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 161 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 161 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 or older (except in South Korea, aged 19 or older). Histologically confirmed marginal zone lymphoma, including extranodal, nodal, and splenic subtypes. Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest transverse diameter and ≥ 1.0 cm in the longest perpendicular diameter. Participants with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed. Participants must be willing to undergo an incisional or excisional lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue. Eastern Cooperative Oncology Group performance status 0 to 2. Exclusion Criteria: Evidence of diffuse large B-cell transformation. History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease. Prior treatment with idelalisib, other selective 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 the first dose of study treatment. Active graft versus host disease. Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-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
35294
Country
United States
Facility Name
Arizona Oncology Associates
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
Torrance Health Association
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Sansum Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Central Coast Medical Oncology
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
UCLA Healthcare Hematology-Oncology
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
St. Joseph Heritage Healthcare
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Innovative Clinical Research Institute
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Loyola University Medical Center
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Valley View Hospital
City
Glenwood Springs
State/Province
Colorado
ZIP/Postal Code
81601
Country
United States
Facility Name
St. Mary'S Hospital Regional Cancer Center
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Facility Name
University of Miami Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Advanced Pharma Cr
City
Miami
State/Province
Florida
ZIP/Postal Code
33147
Country
United States
Facility Name
Boca Raton Clinical Research Medical Inc.
City
Plantation
State/Province
Florida
ZIP/Postal Code
33322
Country
United States
Facility Name
Asclepes Research Centers
City
Weeki Wachee
State/Province
Florida
ZIP/Postal Code
34607
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center - Consultants in Hematology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Clinical Trials of Swla Llc
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
University of Michigan Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Saint Luke'S Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
COMPREHENSIVE CANCER CeNTERS OF NEVADA - TWAIN
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Clinical Research Alliance
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Nyu Cancer Institute
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Hematology Oncology Associates of Rockland
City
Nyack
State/Province
New York
ZIP/Postal Code
10960
Country
United States
Facility Name
White Plains Hospital
City
White Plains
State/Province
New York
ZIP/Postal Code
10601
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Gettysburg Cancer Center
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Facility Name
Charleston Hematology Oncology Associates Pa
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Renovatio Clinical
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
University of Washington - Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Aou Maggiore Della Carita
City
Rosario
ZIP/Postal Code
S2000KZE
Country
Argentina
Facility Name
Icon Cancer Care
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
04066
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
05000
Country
Australia
Facility Name
Calvary North Adelaide Hospital
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
05006
Country
Australia
Facility Name
Cliniques Universitaires Ucl Saint-Luc
City
Brussels
ZIP/Postal Code
01200
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitaire Ziekenhuis Leuven - Gasthuisberg
City
Leuven
ZIP/Postal Code
03000
Country
Belgium
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
09000
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
Centre Hospitalier Universitaire Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Chu Limoges - H�Pital Le Cluzeau
City
Limoges Cedex
ZIP/Postal Code
87042
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
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
City
Pierre-benite
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Institute Gustave Roussy (Igr)
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Universit�Tsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitatsmedizin Gottingen
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Universit�Tsklinikum Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Klinikum Ludwigshafen
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
City
Mainz
ZIP/Postal Code
55131
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 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
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
University of Bologna, Institute of Haematology �L. E A. Ser�Gnoli�
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Fondazione Centro San Raffaele - Milano
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Fondazione Irccs Istituto Nazionale Dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Azienda Ospedaliera San Gerardo Di Monza
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
Azienda Ospedaliera Ospedali Riuniti "Villa Sofia - Cervello"
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Presidio Ospedaliero Pescara
City
Pescara
ZIP/Postal Code
65124
Country
Italy
Facility Name
Ospedale Delle Croci - Ematologia Ravenna
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
Sapienza University
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie
City
Gdansk
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Szpitale Wojew�Dzkie W Gdyni Sp�?Ka Z Ograniczon? Odpowiedzialno?Ci?
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Malopolskie Centrum Medyczne S.C.
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Klinika Transplantacji Komorel Krwiotworczych
City
Warsaw
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Hospital General Universitari Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Ico Institut Catala D Oncologia
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hgu Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Hm Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitario Quironsalud Madrid
City
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hospital Puerta de Hierro
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Kent Oncology Centre - Maidstone Hospital
City
Maidstone
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
University of Southampton
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)

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