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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03126019
Ethics application status
Date submitted
20/04/2017
Date registered
24/04/2017
Date last updated
21/03/2019

Titles & IDs
Public title
An Open-Label Study of Parsaclisib in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)
Scientific title
A Phase 2, Multicenter, Open-Label Study of Parsaclisib, a PI3Kd Inhibitor in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)
Secondary ID [1] 0 0
INCB 50465-203 (CITADEL-203)
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
Treatment: Drugs - Parsaclisib

Experimental: Group A - Parsaclisib once daily (QD) for 8 weeks followed by Parsaclisib once weekly

Experimental: Group B - Parsaclisib QD


Treatment: Drugs: Parsaclisib
Parsaclisib at the protocol-defined starting dose for 8 weeks, followed by Parsaclisib at the protocol-defined dose QD

Treatment: Drugs: Parsaclisib
Parsaclisib at the protocol-defined starting dose for 8 weeks, followed by Parsaclisib at the protocol-defined dose once weekly

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 - Defined as the percentage of subjects with a complete response (CR) or partial response (PR) as determined by an independent review committee.
Timepoint [1] 0 0
Weeks 8, 16, and 24, then every 12 weeks through Week 96, and then every 24 Weeks thereafter until disease progression, up to approximately 12 months.
Secondary outcome [1] 0 0
Complete response rate with parsaclisib based on Lugano classification response criteria - Defined as the percentage of subjects with a CR as determined by an independent review committee.
Timepoint [1] 0 0
Up to approximately 12 months per subject
Secondary outcome [2] 0 0
Duration of response - Defined as the time from first documented evidence of CR or PR until disease progression or death from any cause among subjects who achieve an objective response.
Timepoint [2] 0 0
Up to approximately 24 months per subject
Secondary outcome [3] 0 0
Progression-free survival with parsaclisib - Defined as the time from the date of first dose of study treatment until the earliest date of disease progression or death from any cause.
Timepoint [3] 0 0
Up to approximately 24 months per subject (approximately 12 months for median)
Secondary outcome [4] 0 0
Overall survival with parsaclisib - Defined as the time from the date of first dose of study treatment until death from any cause.
Timepoint [4] 0 0
Up to approximately 36 months per subject
Secondary outcome [5] 0 0
Safety and tolerability of parsaclisib measured by adverse events (AEs) - Defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Timepoint [5] 0 0
Baseline through 30-35 days after end of treatment, up to approximately 12 months per subject

Eligibility
Key inclusion criteria
- Aged 18 years or older.

- Histologically confirmed, relapsed or refractory, follicular B-cell 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
Gender
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 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.

- 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
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,VIC
Recruitment hospital [1] 0 0
Border Medical Oncology Research Unit Albury Wodonga Regional Cancer Center - Albury
Recruitment hospital [2] 0 0
St. Vincent's Hospital Sydney The Kinghorn Cancer - Darlinghurst
Recruitment hospital [3] 0 0
Western Health - Sunshine
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
3021 - Sunshine
Recruitment outside Australia
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United States of America
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Arizona
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California
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Connecticut
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Michigan
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Mississippi
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Missouri
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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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Tennessee
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Texas
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Washington
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Aalborg
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Odense
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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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Mannheim
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Budapest
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Debrecen
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Hungary
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Kaposvár
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Israel
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Anastasia Shabalin
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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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Tel Aviv
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Foggia
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Aviano
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Bari
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Bologna
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Meldola
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Milano
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Modena
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Napoli
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Novara
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Palermo
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Vicenza
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Gdansk
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Kraków
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Opole
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Madrid
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Sanchinarro
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Sevilla
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Stockholm
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Birmingham
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Harrow
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Sheffield

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 objective response rate of parsaclisib treatment
in subjects with relapsed or refractory follicular lymphoma.
Trial website
https://clinicaltrials.gov/show/NCT03126019
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
Incyte Corporation Call Center (US)
Address 0 0
Country 0 0
Phone 0 0
1.855.463.3463
Fax 0 0
Email 0 0
medinfo@incyte.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03126019