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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03144674




Registration number
NCT03144674
Ethics application status
Date submitted
5/05/2017
Date registered
9/05/2017

Titles & IDs
Public title
A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)
Scientific title
A Phase 2, Open-Label, 2-Cohort Study of INCB050465, a PI3Kd Inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma With or Without Prior Exposure to a BTK Inhibitor (CITADEL-204)
Secondary ID [1] 0 0
Parsaclisib
Secondary ID [2] 0 0
INCB 50465-204 (CITADEL-204)
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: Cohort 1- Closed to Further enrollment - Participants who have received prior ibrutinib.

Experimental: Cohort 2 - Participants who have not received a prior BTK inhibitor.


Treatment: Drugs: Parsaclisib
Parsaclisib at the protocol-defined dose.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) Based on Lugano Classification Criteria
Timepoint [1] 0 0
Up to approximately 161 weeks
Secondary outcome [1] 0 0
Duration of Response (DOR)
Timepoint [1] 0 0
Up to approximately 161 weeks
Secondary outcome [2] 0 0
Complete Response Rate (CRR) Based on Lugano Classification Criteria
Timepoint [2] 0 0
Up to approximately 161 weeks
Secondary outcome [3] 0 0
Progression-Free Survival (PFS)
Timepoint [3] 0 0
Up to approximately 161 weeks
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
Up to approximately 161 weeks
Secondary outcome [5] 0 0
Best Percent Change From Baseline in Target Lesion Size
Timepoint [5] 0 0
Up to approximately 161 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 161 weeks

Eligibility
Key inclusion criteria
* Men and women, aged 18 or older (except in South Korea, aged 19 or older).
* Histologically confirmed marginal zone lymphoma, including extranodal, nodal, and splenic subtypes.
* Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of = 1 lesion that measures > 1.5 cm in the longest transverse diameter and = 1.0 cm in the longest perpendicular diameter.
* Participants with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed.
* Participants must be willing to undergo an incisional or excisional lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
* 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
* Evidence of diffuse large B-cell transformation.
* History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
* Prior treatment with idelalisib, other selective PI3Kd inhibitors, or a pan-PI3K inhibitor.
* Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment.
* Active graft versus host disease.
* Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-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
18/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/05/2024
Sample size
Target
Accrual to date
Final
110
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
Icon Cancer Care - Auchenflower
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Calvary North Adelaide Hospital - North Adelaide
Recruitment postcode(s) [1] 0 0
04066 - Auchenflower
Recruitment postcode(s) [2] 0 0
05000 - Adelaide
Recruitment postcode(s) [3] 0 0
05006 - North Adelaide
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
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
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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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United States of America
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South Carolina
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United States of America
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Texas
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United States of America
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Washington
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United States of America
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Wisconsin
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Argentina
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Rosario
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Belgium
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Brussels
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Belgium
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Gent
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Belgium
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Leuven
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Denmark
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Aalborg
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Denmark
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Roskilde
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France
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Bobigny
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France
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Creteil
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France
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Limoges Cedex
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France
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Paris
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France
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Pierre-benite
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France
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Rouen
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France
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Villejuif
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Germany
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Essen
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Germany
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Gottingen
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Germany
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Kiel
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Germany
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Ludwigshafen
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Germany
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Mainz
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Germany
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ULM
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Israel
State/province [38] 0 0
Haifa
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Israel
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Jerusalem
Country [40] 0 0
Israel
State/province [40] 0 0
Petach Tikva
Country [41] 0 0
Israel
State/province [41] 0 0
Ramat Gan
Country [42] 0 0
Israel
State/province [42] 0 0
Tel Aviv
Country [43] 0 0
Italy
State/province [43] 0 0
Bologna
Country [44] 0 0
Italy
State/province [44] 0 0
Meldola
Country [45] 0 0
Italy
State/province [45] 0 0
Milano
Country [46] 0 0
Italy
State/province [46] 0 0
Monza
Country [47] 0 0
Italy
State/province [47] 0 0
Palermo
Country [48] 0 0
Italy
State/province [48] 0 0
Pescara
Country [49] 0 0
Italy
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Ravenna
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Italy
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Rome
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Poland
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Gdansk
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Poland
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Krakow
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Poland
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Warsaw
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Poland
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Warszawa
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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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Majadahonda
Country [58] 0 0
Spain
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Salamanca
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Birmingham
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Maidstone
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Norwich
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Southampton

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
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)?
No
No/undecided IPD sharing reason/comment


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/NCT03144674