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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03126019
Registration number
NCT03126019
Ethics application status
Date submitted
20/04/2017
Date registered
24/04/2017
Date last updated
5/01/2024
Titles & IDs
Public title
A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma
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Scientific title
A Phase 2, Multicenter, Open-Label Study of INCB050465, a PI3Kd Inhibitor in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)
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Secondary ID [1]
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Parsaclisib
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Secondary ID [2]
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INCB 50465-203 (CITADEL-203)
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Universal Trial Number (UTN)
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Trial acronym
CITADEL-203
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective Response Rate With Parsaclisib Based on Lugano Classification Response Criteria
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Assessment method [1]
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ORR=percentage of participants with complete response(CR) or partial response(PR) per revised response criteria for lymphomas,determined by independent review committee(IRC).Criteria for CR:1.Target nodes/nodal masses of lymph nodes,extralymphatic sites regressed to=1.5cm in longest dimension transverse diameter of lesion(LDi);2.Absence of non-measured lesion;3.Organ enlargement regressed to normal;4.No new lesions;5.Normal bone marrow morphology;if indeterminate,immunohistochemistry negative.Criteria for PR:1.Lymph nodes,extralymphatic sites- =50%decrease in sum of product of perpendicular diameters for multiple lesions(SPD)of up to 6 target measurable nodes,extranodal sites;if lesion is too small to measure on computed tomography(CT),assign5mm×5mm as default;if no longer visible,0×0mm.Node>5mm×5mm but smaller than normal,use actual measurement.2.Absent/regressed non-measured lesions,no increase.3.Organ enlargement-Spleen regressed by>50%in length beyond normal.4.No new lesions.
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Timepoint [1]
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Up to approximately 148 weeks
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Secondary outcome [1]
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Complete Response Rate With Parsaclisib Based on Lugano Classification Response Criteria
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Assessment method [1]
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CRR was defined as the percentage of participants with a CR as defined by revised response criteria for lymphomas as determined by an IRC. The criteria for CR included: 1. Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to = 1.5 cm in LDi; 2. Absence of non-measured lesion; 3. Organ enlargement regressed to normal; 4. No new lesions; 5. Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative.
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Timepoint [1]
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Up to approximately 148 weeks
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Secondary outcome [2]
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Duration of Response (DOR)
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Assessment method [2]
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DOR=time from first documented evidence of CR or PR until disease progression or death from any cause among participants who achieve an objective response as determined by IRC. Criteria for CR: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to = 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative. The criteria for PR included: 1.Lymph nodes and extralymphatic sites- a. =50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; b. when a lesion is too small to measure on CT, assign 5 mm×5 mm as the default; c.when no longer visible, 0×0 mm. For a node >5 mm×5 mm but smaller than normal, use actual measurement. 2.Non-measured lesions- Absent/regressed, but no increase. 3. Organ enlargement-Spleen must have regressed by >50% in length beyond normal. 4.No new lesions.
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Timepoint [2]
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Up to approximately 148 weeks
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Secondary outcome [3]
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Progression-free Survival (PFS) With Parsaclisib
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Assessment method [3]
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PFS was defined as the time from the date of the first dose of study treatment until the earliest date of disease progression, as determined by radiographic disease assessment provided by an IRC, or death from any cause.
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Timepoint [3]
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Up to approximately 148 weeks
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Secondary outcome [4]
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Overall Survival (OS) With Parsaclisib
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Assessment method [4]
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OS was defined as the time from the date of the first dose of study treatment until death from any cause.
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Timepoint [4]
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Up to approximately 148 weeks
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Secondary outcome [5]
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Best Percent Change From Baseline in Target Lesion Size
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Assessment method [5]
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Target lesion size is measured by the sum of the product of diameters of all target lesion sizes and is determined by the IRC. The best percent change from Baseline is defined as the largest decrease, or smallest increase (if no decrease available), from Baseline in target lesion sizes on/before new (next-line) anti-lymphoma therapy during the study. Baseline is the last non-missing measurement obtained before the first administration of study drug. A negative percent change from Baseline indicates improvement.
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Timepoint [5]
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Up to approximately 148 weeks
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Secondary outcome [6]
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Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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Assessment method [6]
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An adverse event (AE) is defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug and within 30 days of last administration of study drug regardless of starting new anti-lymphoma therapy. SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is considered to be an important medical event that may not result in death, be immediately life-threatening, or require hospitalization but may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant or may require medical or surgical intervention.
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Timepoint [6]
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From first dose of study drug up to approximately 148 weeks
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/03/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/07/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
126
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Western Health - St Albans
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Border Medical Oncology - Wodonga
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St Vincent'S Hospital Sydney - Darlinghurst
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03021 - St Albans
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Recruitment postcode(s) [2]
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03690 - Wodonga
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Recruitment postcode(s) [3]
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02010 - Darlinghurst
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Incyte Corporation
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the objective response rate of parsaclisib treatment
in participants with relapsed or refractory follicular lymphoma.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03126019
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Fred Zheng, MD, PhD
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Address
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Incyte Corporation
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03126019
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