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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/NCT03144674
Registration number
NCT03144674
Ethics application status
Date submitted
5/05/2017
Date registered
9/05/2017
Date last updated
5/02/2024
Titles & IDs
Public title
A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)
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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)
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Secondary ID [1]
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Parsaclisib
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Secondary ID [2]
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INCB 50465-204 (CITADEL-204)
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Universal Trial Number (UTN)
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Trial acronym
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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: 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.
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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 (ORR) Based on Lugano Classification 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),assign 5mm×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 161 weeks
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Secondary outcome [1]
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Duration of Response (DOR)
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Assessment method [1]
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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 [1]
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Up to approximately 161 weeks
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Secondary outcome [2]
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Complete Response Rate (CRR) Based on Lugano Classification Criteria
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Assessment method [2]
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CRR is defined as the percentage of participants with a CR 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 [2]
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Up to approximately 161 weeks
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Secondary outcome [3]
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Progression-Free Survival (PFS)
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Assessment method [3]
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PFS is 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 161 weeks
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Secondary outcome [4]
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Overall Survival (OS)
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Assessment method [4]
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OS is 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 161 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 nonmissing 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 161 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 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. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug regardless of starting new anti-lymphoma therapy. A 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 161 weeks
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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.
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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
- 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.
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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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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
18/12/2017
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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
31/05/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
110
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Recruitment in Australia
Recruitment state(s)
QLD,SA
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Recruitment hospital [1]
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Icon Cancer Care - Auchenflower
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Recruitment hospital [2]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [3]
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Calvary North Adelaide Hospital - North Adelaide
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04066 - Auchenflower
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Recruitment postcode(s) [2]
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05000 - Adelaide
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Recruitment postcode(s) [3]
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05006 - North Adelaide
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Recruitment outside Australia
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Norwich
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Funding & Sponsors
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Commercial sector/Industry
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Name
Incyte Corporation
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03144674
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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
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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/NCT03144674
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