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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
Date last updated
17/07/2024

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
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Louisiana
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Michigan
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Missouri
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Nevada
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New York
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Texas
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Washington
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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
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Haifa
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Israel
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Jerusalem
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Israel
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Petach Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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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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Monza
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Italy
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Palermo
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Italy
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Pescara
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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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Krakow
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Warsaw
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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
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Spain
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Salamanca
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United Kingdom
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Birmingham
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United Kingdom
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Maidstone
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United Kingdom
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Norwich
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United Kingdom
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Southampton

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 evaluate the safety and efficacy of two parsaclisib treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL) who are naive to or were previously treated with a Bruton's tyrosine kinase (BTK) inhibitor.
Trial website
https://clinicaltrials.gov/study/NCT03144674
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03144674