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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03235544




Registration number
NCT03235544
Ethics application status
Date submitted
27/07/2017
Date registered
1/08/2017

Titles & IDs
Public title
A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor
Scientific title
A Phase 2, Open-Label, 2-Cohort, Multicenter Study of INCB050465, a PI3Kd Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)
Secondary ID [1] 0 0
Parsaclisib
Secondary ID [2] 0 0
INCB 50465-205 (CITADEL-205)
Universal Trial Number (UTN)
Trial acronym
(CITADEL-205)
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: Treatment A (Exposed to Ibrutinib) - Participants received parsaclisib 20 mg tablets, orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks.

Participants who were exposed to ibrutinib before enrollment were included in this group.

Experimental: Cohort 1: Treatment B (Exposed to Ibrutinib) - Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks.

Participants who were exposed to ibrutinib before enrollment were included in this group.

Experimental: Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) - Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks.

Participants who had not received a BTK inhibitor previously were included in this group.

Experimental: Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) - Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks.

Participants who had not received a BTK inhibitor previously were included in this group.


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 (ORR)
Timepoint [1] 0 0
Up to 1016 days
Secondary outcome [1] 0 0
Duration of Response (DOR)
Timepoint [1] 0 0
Up to 1016 days
Secondary outcome [2] 0 0
Complete Response Rate (CRR)
Timepoint [2] 0 0
Up to 1016 days
Secondary outcome [3] 0 0
Progression-Free Survival (PFS)
Timepoint [3] 0 0
Up to 1016 days
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
Up to 2017 days
Secondary outcome [5] 0 0
Best Percent Change From Baseline in Target Lesion Size
Timepoint [5] 0 0
Up to 1016 days
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 2045 days

Eligibility
Key inclusion criteria
* Men and women, aged 18 years or older.
* Documented failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent treatment regimen.
* Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy.
* Eastern Cooperative Oncology Group (ECOG) performance status of = 2.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.
* Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of first dose of study treatment.
* Active graft-versus-host disease.
* Liver 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
20/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/04/2024
Sample size
Target
Accrual to date
Final
162
Recruitment in Australia
Recruitment state(s)
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
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
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
Mississippi
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
Belgium
State/province [14] 0 0
Oost-Vlaanderen
Country [15] 0 0
Belgium
State/province [15] 0 0
Brussels
Country [16] 0 0
Belgium
State/province [16] 0 0
La Louviere
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Czechia
State/province [18] 0 0
Hradec Kralove
Country [19] 0 0
Czechia
State/province [19] 0 0
Prague 10
Country [20] 0 0
Czechia
State/province [20] 0 0
Prague 2
Country [21] 0 0
Czechia
State/province [21] 0 0
Prague
Country [22] 0 0
Denmark
State/province [22] 0 0
Aalborg
Country [23] 0 0
Denmark
State/province [23] 0 0
Aarhus
Country [24] 0 0
Denmark
State/province [24] 0 0
Odense C
Country [25] 0 0
Denmark
State/province [25] 0 0
Roskilde
Country [26] 0 0
France
State/province [26] 0 0
Bobigny
Country [27] 0 0
France
State/province [27] 0 0
Clermont-ferrand
Country [28] 0 0
France
State/province [28] 0 0
Creteil
Country [29] 0 0
France
State/province [29] 0 0
Grenoble
Country [30] 0 0
France
State/province [30] 0 0
La Roche Sur Yon
Country [31] 0 0
France
State/province [31] 0 0
La Tronche
Country [32] 0 0
France
State/province [32] 0 0
Le Chesnay
Country [33] 0 0
France
State/province [33] 0 0
Lyon
Country [34] 0 0
France
State/province [34] 0 0
Nice
Country [35] 0 0
France
State/province [35] 0 0
Paris
Country [36] 0 0
France
State/province [36] 0 0
Pierre-Bénite Cedex
Country [37] 0 0
France
State/province [37] 0 0
Poitiers
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France
State/province [38] 0 0
Rouen
Country [39] 0 0
France
State/province [39] 0 0
Tours
Country [40] 0 0
France
State/province [40] 0 0
Villejuif Cedex
Country [41] 0 0
Germany
State/province [41] 0 0
Augsburg
Country [42] 0 0
Germany
State/province [42] 0 0
Essen
Country [43] 0 0
Germany
State/province [43] 0 0
Giessen
Country [44] 0 0
Germany
State/province [44] 0 0
Mainz
Country [45] 0 0
Germany
State/province [45] 0 0
Moenchengladbach
Country [46] 0 0
Germany
State/province [46] 0 0
Munchen
Country [47] 0 0
Germany
State/province [47] 0 0
ULM
Country [48] 0 0
Israel
State/province [48] 0 0
Haifa
Country [49] 0 0
Israel
State/province [49] 0 0
Jerusalem
Country [50] 0 0
Israel
State/province [50] 0 0
Petach Tikva
Country [51] 0 0
Israel
State/province [51] 0 0
Tel Aviv
Country [52] 0 0
Italy
State/province [52] 0 0
MI
Country [53] 0 0
Italy
State/province [53] 0 0
Bologna
Country [54] 0 0
Italy
State/province [54] 0 0
Catania
Country [55] 0 0
Italy
State/province [55] 0 0
Milano
Country [56] 0 0
Italy
State/province [56] 0 0
Modena
Country [57] 0 0
Italy
State/province [57] 0 0
Napoli
Country [58] 0 0
Italy
State/province [58] 0 0
Novara
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Italy
State/province [59] 0 0
Palermo
Country [60] 0 0
Italy
State/province [60] 0 0
Rome
Country [61] 0 0
Italy
State/province [61] 0 0
Siena
Country [62] 0 0
Italy
State/province [62] 0 0
Torino
Country [63] 0 0
Poland
State/province [63] 0 0
Bielsko-biala
Country [64] 0 0
Poland
State/province [64] 0 0
Brzozow
Country [65] 0 0
Poland
State/province [65] 0 0
Gdansk
Country [66] 0 0
Poland
State/province [66] 0 0
Krakow
Country [67] 0 0
Poland
State/province [67] 0 0
Tomaszow Mazowiecki
Country [68] 0 0
Poland
State/province [68] 0 0
Warszawa
Country [69] 0 0
Spain
State/province [69] 0 0
Barcelona
Country [70] 0 0
Spain
State/province [70] 0 0
Burgos
Country [71] 0 0
Spain
State/province [71] 0 0
Madrid
Country [72] 0 0
Spain
State/province [72] 0 0
Murcia
Country [73] 0 0
Spain
State/province [73] 0 0
Pamplona
Country [74] 0 0
Spain
State/province [74] 0 0
Salamanca
Country [75] 0 0
Spain
State/province [75] 0 0
Sevilla
Country [76] 0 0
Spain
State/province [76] 0 0
Valencia
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Birmingham
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Edinburgh
Country [79] 0 0
United Kingdom
State/province [79] 0 0
London
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Plymouth
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Sheffield

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


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/NCT03235544