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A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)

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 Follicular lymphoma, non-Hodgkin lymphoma (NHL), phosphatidylinositol 3-kinase (PI3K) δ inhibitor

Eligibility Criteria

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

Inclusion Criteria:

  • Aged 18 years or older.
  • Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (NHL) (follicular lymphoma) Grade 1, 2, and 3a.
  • Ineligible for hematopoietic stem cell transplant.
  • Must have been treated with at least 2 prior systemic therapies.
  • Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest dimension and ≥ 1.0 cm in the longest perpendicular dimension as assessed by computed tomography or magnetic resonance imaging.
  • Must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

Exclusion Criteria:

  • Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.
  • 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.
  • Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).
  • Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of study treatment administration.
  • Active graft-versus-host 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

  • Arizona Oncology Associates - Biltmore Cancer Center
  • Beverly Hills Cancer Center
  • Synergy Hematology and Oncology Medical Associates
  • St. Joseph Heritage Healthcare
  • American Institute of Research Corporate Office
  • Cancer Center of Central Connecticut
  • Florida Cancer Specialists & Research Institute
  • Asclepes Research Centers
  • Clinical Trials of Swla Llc
  • Saint Agnes Hospital
  • Barbara Ann Karmanos Cancer Hospital
  • Hattiesburg Clinic Hematology
  • Saint Luke'S Hospital
  • Sarah Cannon Research Institute
  • Clinical Research Alliance, Inc.
  • Duke University Medical Center
  • Gabrail Cancer Center
  • University of Pennsylvania Health System
  • Charleston Hematology Oncology Associates Pa
  • Tennessee Oncology
  • Renovatio Clinical Consultants Llc
  • University of Washington
  • Western Health
  • Border Medical Oncology
  • St Vincent'S Hospital Sydney
  • Saint John Regional Hospital
  • Sunnybrook Health Science Centre
  • Santa Cabrini Hospital
  • University Hospital Hradec Kralove
  • Fakultni Nemocnice Ostrava
  • University Hospital Kralovkse Vinohrady
  • Fakultni Nemocnice V Motole
  • Univerzita Karlova V Praze 1. Lekarska Fakulta
  • Aalborg University Hospital
  • Odense Universitetshospital (Ouh) (Odense University Hospital)
  • Bag Arnoldstr. Dresden
  • University Medical Center Freiburg
  • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
  • University Hospital Mannheim
  • Semmelweis Egyetem
  • National Institute of Oncology
  • University of Debrecen
  • Somogy Medyei Kaposi Mor Oktato Korhaz
  • Hillel Yafe Medical Center (Hymc)
  • Rambam Medical Center
  • Laniado Hospital Hematology
  • Sheba Medical Center
  • Tel Aviv Sourasky Medical Center
  • Irccs Centro Di Riferimento Oncologico
  • Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
  • University of Bologna
  • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
  • Ospedale San Raffaele
  • Fondazione Irccs Istituto Nazionale Dei Tumori
  • A.O.U. Di Modena - Policlinico
  • A.O.U. Federico Ii
  • Aou Maggiore Della Carita
  • Ospedali Riuniti Villa Sofia Cervello
  • Sapienza University
  • I.R.C.C.S. Casa Sollievo Della Sofferenza
  • Aou Citta Della Salute E Della Scienza Di Torino
  • San Bartolo Hospital
  • Uniwersyteckie Centrum Kliniczne
  • Pratia McM Krakow
  • State Hospital Opole
  • Institute of Hematology and Transfusion Medicine
  • Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie
  • Hospital de La Santa Creu I Sant Pau
  • Hospital General Universitari Vall D Hebron
  • Hgu Gregorio Maranon
  • Md Anderson Cancer Centre Madrid
  • Hospital Universitario Ramon Y Cajal
  • Hospital Universitario de La Paz
  • Hospital Universitario Hm Sanchinarro
  • Hospital Universitario Quironsalud Madrid
  • Hospital Universitario de Canarias
  • Hospital Universitario Virgen Macarena
  • Hospital Universitario Virgen Del Rocio
  • Karolinska University Hospital, Huddinge
  • Birmingham Heartlands Hospital
  • Northwick Park Hospital
  • Royal Hallamshire Hospital
  • The Royal Marsden Nhs Foundation Trust - Chelsea

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW

Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD

Arm Description

Participants received parsaclisib 20 mg once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.

Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.

Outcomes

Primary Outcome Measures

Objective Response Rate With Parsaclisib Based on Lugano Classification Response 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),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

Complete Response Rate With Parsaclisib Based on Lugano Classification Response Criteria
CRR was defined as the percentage of participants with a CR as defined by revised 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.
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.
Progression-free Survival (PFS) With Parsaclisib
PFS was 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) With Parsaclisib
OS was 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 non-missing 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 defined as 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. TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug and within 30 days of last administration of study drug regardless of starting new anti-lymphoma therapy. 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
April 20, 2017
Last Updated
July 20, 2023
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03126019
Brief Title
A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma
Acronym
CITADEL-203
Official Title
A Phase 2, Multicenter, Open-Label Study of INCB050465, a PI3Kδ Inhibitor in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 14, 2018 (Actual)
Primary Completion Date
February 26, 2021 (Actual)
Study Completion Date
July 31, 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
The purpose of this study is to assess the objective response rate of parsaclisib treatment in participants with relapsed or refractory follicular lymphoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Follicular lymphoma, non-Hodgkin lymphoma (NHL), phosphatidylinositol 3-kinase (PI3K) δ inhibitor

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW
Arm Type
Experimental
Arm Description
Participants received parsaclisib 20 mg once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.
Arm Title
Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD
Arm Type
Experimental
Arm Description
Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
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 With Parsaclisib Based on Lugano Classification Response 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),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 148 weeks
Secondary Outcome Measure Information:
Title
Complete Response Rate With Parsaclisib Based on Lugano Classification Response Criteria
Description
CRR was defined as the percentage of participants with a CR as defined by revised 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 148 weeks
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 148 weeks
Title
Progression-free Survival (PFS) With Parsaclisib
Description
PFS was 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 148 weeks
Title
Overall Survival (OS) With Parsaclisib
Description
OS was defined as the time from the date of the first dose of study treatment until death from any cause.
Time Frame
Up to approximately 148 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 non-missing measurement obtained before the first administration of study drug. A negative percent change from Baseline indicates improvement.
Time Frame
Up to approximately 148 weeks
Title
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
An adverse event (AE) is defined as 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. TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug and within 30 days of last administration of study drug regardless of starting new anti-lymphoma therapy. 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 148 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 years or older. Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (NHL) (follicular lymphoma) Grade 1, 2, and 3a. Ineligible for hematopoietic stem cell transplant. Must have been treated with at least 2 prior systemic therapies. Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest dimension and ≥ 1.0 cm in the longest perpendicular dimension as assessed by computed tomography or magnetic resonance imaging. Must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. Exclusion Criteria: Known histological transformation from indolent NHL to diffuse large B-cell lymphoma. 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. Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib). Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of study treatment administration. Active graft-versus-host 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, PhD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Oncology Associates - Biltmore Cancer Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Beverly Hills Cancer Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Synergy Hematology and Oncology Medical Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
St. Joseph Heritage Healthcare
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
American Institute of Research Corporate Office
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Cancer Center of Central Connecticut
City
Southington
State/Province
Connecticut
ZIP/Postal Code
06489
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Asclepes Research Centers
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34606
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
Saint Agnes Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Hattiesburg Clinic Hematology
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Saint Luke'S Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
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
27710
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
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
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Renovatio Clinical Consultants Llc
City
Spring
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Western Health
City
St Albans
State/Province
Victoria
ZIP/Postal Code
03021
Country
Australia
Facility Name
Border Medical Oncology
City
Wodonga
State/Province
Victoria
ZIP/Postal Code
03690
Country
Australia
Facility Name
St Vincent'S Hospital Sydney
City
Darlinghurst
ZIP/Postal Code
02010
Country
Australia
Facility Name
Saint John Regional Hospital
City
St. John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Sunnybrook Health Science Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Santa Cabrini Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1P7
Country
Canada
Facility Name
University Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni Nemocnice Ostrava
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
University Hospital Kralovkse Vinohrady
City
Prague
ZIP/Postal Code
10034
Country
Czechia
Facility Name
Fakultni Nemocnice V Motole
City
Praha 5
ZIP/Postal Code
15000
Country
Czechia
Facility Name
Univerzita Karlova V Praze 1. Lekarska Fakulta
City
Praha
ZIP/Postal Code
120 0
Country
Czechia
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
09000
Country
Denmark
Facility Name
Odense Universitetshospital (Ouh) (Odense University Hospital)
City
Odense C
ZIP/Postal Code
05000
Country
Denmark
Facility Name
Bag Arnoldstr. Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
University Medical Center Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
University Hospital Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
01085
Country
Hungary
Facility Name
National Institute of Oncology
City
Budapest
ZIP/Postal Code
01122
Country
Hungary
Facility Name
University of Debrecen
City
Debrecen
ZIP/Postal Code
04032
Country
Hungary
Facility Name
Somogy Medyei Kaposi Mor Oktato Korhaz
City
Kaposvar
ZIP/Postal Code
07400
Country
Hungary
Facility Name
Hillel Yafe Medical Center (Hymc)
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Laniado Hospital Hematology
City
Netanya
ZIP/Postal Code
42150
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv-yafo
ZIP/Postal Code
64239
Country
Israel
Facility Name
Irccs Centro Di Riferimento Oncologico
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
University of Bologna
City
Bologna
ZIP/Postal Code
40126
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
Ospedale San Raffaele
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
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
I.R.C.C.S. Casa Sollievo Della Sofferenza
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
Aou Citta Della Salute E Della Scienza Di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
San Bartolo Hospital
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Facility Name
Uniwersyteckie Centrum Kliniczne
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
State Hospital Opole
City
Opole
ZIP/Postal Code
45-372
Country
Poland
Facility Name
Institute of Hematology and Transfusion Medicine
City
Warszawa
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 de La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08026
Country
Spain
Facility Name
Hospital General Universitari Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hgu Gregorio Maranon
City
Madrid
ZIP/Postal Code
28009
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
Hospital Universitario de La Paz
City
Madrid
ZIP/Postal Code
28046
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 Universitario de Canarias
City
San Cristobal de La Laguna
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41007
Country
Spain
Facility Name
Hospital Universitario Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Karolinska University Hospital, Huddinge
City
Stockholm
ZIP/Postal Code
14141
Country
Sweden
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Northwick Park Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
The Royal Marsden Nhs Foundation Trust - Chelsea
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
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 Follicular Lymphoma

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