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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02998476
Ethics application status
Date submitted
13/12/2016
Date registered
20/12/2016
Date last updated
24/04/2020

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 - Defined as the percentage of subjects with a complete or partial response as defined by Lugano Classification criteria for lymphomas (Cheson et al 2014) as determined by IRC.
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 - Defined as the time from first documented evidence of complete or partial response until disease progression or death from any cause among subjects who achieve an objective response as determined by IRC.
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 - Defined as the time from the date of the first dose of study drug until the earliest date of disease progression, as determined by radiographic disease assessment as provided by an IRC.
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 - Defined as the time from the date of the first dose of study drug until death by any cause.
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 - A TEAE is any AE either reported for the first time or worsening of a pre-existing event after the first dose of parsaclisib until 30 days after the last dose administration.
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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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United States of America
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Alabama
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Arizona
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California
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Florida
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Illinois
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Indiana
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Kentucky
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Maryland
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Michigan
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Nebraska
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New Jersey
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New York
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Pennsylvania
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Utah
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Belgium
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Antwerpen
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Belgium
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Leuven
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Belgium
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Roeselare
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Canada
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Ontario
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Ostrava - Poruba
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Czechia
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Praha 5
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France
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Alpes Maritimes
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France
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Calvados
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France
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Cote dÝOr
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France
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Gironde
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France
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Isere
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Maine Et Loire
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France
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Meurthe Et Moselle
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France
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Nord
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France
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Paris
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France
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Rhone
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France
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Sarthe
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France
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Val De Marne
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Italy
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Foggia
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Italy
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Bari
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Korea, Republic of
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Seoul
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Poland
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Brzozów
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Poland
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Gdansk
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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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Sevilla
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United Kingdom
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Greater Manchester
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United Kingdom
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Sutton

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the safety and efficacy of parsaclisib in subjects
with relapsed or refractory diffuse large B-cell lymphoma.
Trial website
https://clinicaltrials.gov/show/NCT02998476
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

Summary results
Other publications