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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02998476




Registration number
NCT02998476
Ethics application status
Date submitted
13/12/2016
Date registered
20/12/2016
Date last updated
10/03/2022

Titles & IDs
Public title
A Phase 2 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)
Scientific title
A Phase 2, Multicenter, International, Open-Label, Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)
Secondary ID [1] 0 0
Parsaclisib
Secondary ID [2] 0 0
INCB 50465-202/CITADEL-202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Parsaclisib

Experimental: Group A Parsaclisib (no prior BTK inhibitor) - Parsaclisib in subjects who were not previously treated with a BTK inhibitor.

Experimental: Group B Parsaclisib (prior BTK inhibitor) - Parsaclisib in subjects who were previously treated with a BTK inhibitor.


Treatment: Drugs: Parsaclisib
Parsaclisib once daily for 8 weeks followed by once weekly
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate Based on Lugano Classification Criteria in Group A
Timepoint [1] 0 0
Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months
Secondary outcome [1] 0 0
Duration of Response in Group A
Timepoint [1] 0 0
Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months
Secondary outcome [2] 0 0
Progression-free Survival in Group A
Timepoint [2] 0 0
Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months
Secondary outcome [3] 0 0
Overall Survival (OS) in Group A
Timepoint [3] 0 0
From first dose of study drug until death by any cause; up to 26 months
Secondary outcome [4] 0 0
Safety as Assessed by Percentage of Subjects With Adverse Events in Group A and Group B
Timepoint [4] 0 0
Screening through 35 days after end of treatment, up to 42 months

Eligibility
Key inclusion criteria
* Eligible 19 years and older in South Korea
* Relapsed or refractory DLBCL, which has been histologically documented, defined as having received at least 2 but no more than 5 prior treatment regimens and ineligible for high-dose chemotherapy supported by autologous stem cell transplant.
* Must have = 1 measurable lesion (=2 cm in longest dimension) or = 1 measurable extranodal lesion (=1 cm in longest dimension) on computed tomography (CT) scan or magnetic resonance imaging (MRI).
* Subjects must be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy or provide the most recent, available archived tumor biopsy.
* Eastern Cooperative Oncology Group performance status 0 to 2.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Primary mediastinal (thymic) large B-cell lymphoma.
* Known brain or central nervous system metastases or history of uncontrolled seizures.
* Allogeneic stem cell transplant within the last 6 months, or active graft versus host disease following allogeneic transplant, or autologous stem cell transplant within the last 3 months.
* Use or expected use during the study of any prohibited medications, including potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half lives (whichever is longer) before the first dose of study drug.
* Prior treatment with the following:

* Group A: Prior treatment with a selective phosphatidylinositol 3-kinase (PI3K) d inhibitor (eg, idelalisib), a pan-PI3K inhibitor, or a BTK inhibitor (eg, ibrutinib).
* Group B: Prior treatment with a selective PI3Kd inhibitor (eg, idelalisib) or a pan PI3K inhibitor.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/02/2021
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [4] 0 0
Ballarat Base Hospital - Ballarat
Recruitment hospital [5] 0 0
Sunshine Hospital - St Albans
Recruitment hospital [6] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
3350 - Ballarat
Recruitment postcode(s) [5] 0 0
3021 - St Albans
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
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United States of America
State/province [7] 0 0
Kentucky
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United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
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United States of America
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New York
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United States of America
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Pennsylvania
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United States of America
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Utah
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Belgium
State/province [15] 0 0
Antwerpen
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Belgium
State/province [16] 0 0
Brussels
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
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Belgium
State/province [18] 0 0
Roeselare
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
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Czechia
State/province [20] 0 0
Brno
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Czechia
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Hradec Kralove
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Czechia
State/province [22] 0 0
Ostrava
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Czechia
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Praha 5
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France
State/province [24] 0 0
Alpes Maritimes
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France
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Calvados
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France
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Cote dÝOr
Country [27] 0 0
France
State/province [27] 0 0
Gironde
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France
State/province [28] 0 0
Isere
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France
State/province [29] 0 0
Maine Et Loire
Country [30] 0 0
France
State/province [30] 0 0
Nord
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France
State/province [31] 0 0
Paris
Country [32] 0 0
France
State/province [32] 0 0
Sarthe
Country [33] 0 0
France
State/province [33] 0 0
Val De Marne
Country [34] 0 0
France
State/province [34] 0 0
Grenoble
Country [35] 0 0
France
State/province [35] 0 0
Vandoeuvre-les-nancy
Country [36] 0 0
France
State/province [36] 0 0
Villejuif Cedex
Country [37] 0 0
Italy
State/province [37] 0 0
Foggia
Country [38] 0 0
Italy
State/province [38] 0 0
Bari
Country [39] 0 0
Italy
State/province [39] 0 0
Meldola
Country [40] 0 0
Italy
State/province [40] 0 0
Rome
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Seoul
Country [42] 0 0
Poland
State/province [42] 0 0
Brzozów
Country [43] 0 0
Poland
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Gdansk
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Poland
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Krakow
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Pamplona
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Spain
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Sevilla
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Spain
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Vitoria
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United Kingdom
State/province [50] 0 0
Greater Manchester
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Southend-on-sea
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Incyte Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Claudia Corrado, MD
Address 0 0
Incyte Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02998476