Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
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
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah
Country [15] 0 0
Belgium
State/province [15] 0 0
Antwerpen
Country [16] 0 0
Belgium
State/province [16] 0 0
Brussels
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Belgium
State/province [18] 0 0
Roeselare
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Czechia
State/province [20] 0 0
Brno
Country [21] 0 0
Czechia
State/province [21] 0 0
Hradec Kralove
Country [22] 0 0
Czechia
State/province [22] 0 0
Ostrava
Country [23] 0 0
Czechia
State/province [23] 0 0
Praha 5
Country [24] 0 0
France
State/province [24] 0 0
Alpes Maritimes
Country [25] 0 0
France
State/province [25] 0 0
Calvados
Country [26] 0 0
France
State/province [26] 0 0
Cote dÝOr
Country [27] 0 0
France
State/province [27] 0 0
Gironde
Country [28] 0 0
France
State/province [28] 0 0
Isere
Country [29] 0 0
France
State/province [29] 0 0
Maine Et Loire
Country [30] 0 0
France
State/province [30] 0 0
Nord
Country [31] 0 0
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
State/province [43] 0 0
Gdansk
Country [44] 0 0
Poland
State/province [44] 0 0
Krakow
Country [45] 0 0
Spain
State/province [45] 0 0
Barcelona
Country [46] 0 0
Spain
State/province [46] 0 0
Madrid
Country [47] 0 0
Spain
State/province [47] 0 0
Pamplona
Country [48] 0 0
Spain
State/province [48] 0 0
Sevilla
Country [49] 0 0
Spain
State/province [49] 0 0
Vitoria
Country [50] 0 0
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