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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03126019




Registration number
NCT03126019
Ethics application status
Date submitted
20/04/2017
Date registered
24/04/2017

Titles & IDs
Public title
A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma
Scientific title
A Phase 2, Multicenter, Open-Label Study of INCB050465, a PI3Kd Inhibitor in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)
Secondary ID [1] 0 0
Parsaclisib
Secondary ID [2] 0 0
INCB 50465-203 (CITADEL-203)
Universal Trial Number (UTN)
Trial acronym
CITADEL-203
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: Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW - Participants received parsaclisib 20 mg once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.

Experimental: Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD - Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.


Treatment: Drugs: Parsaclisib
Parsaclisib tablets administered orally with water and without regard to food
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate With Parsaclisib Based on Lugano Classification Response Criteria
Timepoint [1] 0 0
Up to approximately 148 weeks
Secondary outcome [1] 0 0
Complete Response Rate With Parsaclisib Based on Lugano Classification Response Criteria
Timepoint [1] 0 0
Up to approximately 148 weeks
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Up to approximately 148 weeks
Secondary outcome [3] 0 0
Progression-free Survival (PFS) With Parsaclisib
Timepoint [3] 0 0
Up to approximately 148 weeks
Secondary outcome [4] 0 0
Overall Survival (OS) With Parsaclisib
Timepoint [4] 0 0
Up to approximately 148 weeks
Secondary outcome [5] 0 0
Best Percent Change From Baseline in Target Lesion Size
Timepoint [5] 0 0
Up to approximately 148 weeks
Secondary outcome [6] 0 0
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timepoint [6] 0 0
From first dose of study drug up to approximately 148 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 (PI3Kd) 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).

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
Other
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
14/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/06/2024
Sample size
Target
Accrual to date
Final
126
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Western Health - St Albans
Recruitment hospital [2] 0 0
Border Medical Oncology - Wodonga
Recruitment hospital [3] 0 0
St Vincent'S Hospital Sydney - Darlinghurst
Recruitment postcode(s) [1] 0 0
03021 - St Albans
Recruitment postcode(s) [2] 0 0
03690 - Wodonga
Recruitment postcode(s) [3] 0 0
02010 - Darlinghurst
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
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Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
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United States of America
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Michigan
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United States of America
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Mississippi
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United States of America
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Missouri
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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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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
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Canada
State/province [18] 0 0
New Brunswick
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
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Canada
State/province [20] 0 0
Quebec
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Czechia
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Hradec Kralove
Country [22] 0 0
Czechia
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Ostrava
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Czechia
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Prague
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Czechia
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Praha 5
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Czechia
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Praha
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Denmark
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Aalborg
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Denmark
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Odense C
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Germany
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Dresden
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Germany
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Freiburg
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Germany
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Mainz
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Germany
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Mannheim
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Kaposvar
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Israel
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Hadera
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Israel
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Haifa
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Israel
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Netanya
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Israel
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Ramat Gan
Country [39] 0 0
Israel
State/province [39] 0 0
Tel Aviv-yafo
Country [40] 0 0
Italy
State/province [40] 0 0
Aviano
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Italy
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Bari
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Italy
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Bologna
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Italy
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Meldola
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Italy
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Milano
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Italy
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Modena
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Italy
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Napoli
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Italy
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Novara
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Italy
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Palermo
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Italy
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Rome
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Italy
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San Giovanni Rotondo
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Italy
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Torino
Country [52] 0 0
Italy
State/province [52] 0 0
Vicenza
Country [53] 0 0
Poland
State/province [53] 0 0
Gdansk
Country [54] 0 0
Poland
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Krakow
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Poland
State/province [55] 0 0
Opole
Country [56] 0 0
Poland
State/province [56] 0 0
Warszawa
Country [57] 0 0
Spain
State/province [57] 0 0
Barcelona
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Spain
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Madrid
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Spain
State/province [59] 0 0
San Cristobal de La Laguna
Country [60] 0 0
Spain
State/province [60] 0 0
Sevilla
Country [61] 0 0
Sweden
State/province [61] 0 0
Stockholm
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Birmingham
Country [63] 0 0
United Kingdom
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London
Country [64] 0 0
United Kingdom
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Sheffield
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United Kingdom
State/province [65] 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
Fred Zheng, MD, PhD
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Available to whom?
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
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.incyte.com/our-company/compliance-and-transparency


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/NCT03126019