Back to resultsTo Evaluate Efficacy and Safety of Parsaclisib Plus Either Rituximab or Obinutuzumab in R/R Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL) (CITADEL-302)
Primary Purpose
Follicular Lymphoma ( FL), Marginal Zone Lymphoma (MZL)
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
parsaclisib
rituximab
obinutuzumab
Sponsored by
About this trial
This is an interventional treatment trial for Follicular Lymphoma ( FL) focused on measuring parsaclisib, Relapsed/Refractory, obinutuzumab, rituximab
Eligibility Criteria
Inclusion Criteria:
- Male and female participants aged 18 years or older (Japan, aged 20 years or older).
- Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL
- Prior systemic treatment with at least 1 anti-CD20 mAb (either as monotherapy or in combination as chemoimmunotherapy)
- Documented disease that has relapsed or progressed or was refractory after the most recent prior systemic therapy. Note: Participants must not be refractory to anti-CD20 mAb
- Radiographically (CT, MRI) measurable lymphadenopathy per the Lugano criteria for response assessment (Cheson et al 2014).
- ECOG PS of 0 to 2
- Adequate organ functions including hematopoiesis, liver, and kidney
- Willingness to avoid pregnancy or fathering children
Exclusion Criteria:
- Women who are pregnant or breastfeeding.
- Known histological transformation from indolent NHL to an aggressive NHL (eg, diffuse large B-cell lymphoma).
- Presence of CNS lymphoma (either primary or secondary) or leptomeningeal disease.
- Prior treatment with PI3K inhibitors.
- Inadequate washout of immunosuppressive therapy, anticancer medications and investigational drugs.
- Significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, GI, endocrine, pulmonary, neurological, cerebral, cardiac, infectious, or psychiatric disease.
- Known HIV infection.
- HBV or HCV infection: Participants positive for HBsAg or anti-HBc will be eligible if they are negative for HBV-DNA; these participants must receive prophylactic antiviral therapy. Participants positive for HCV antibody will be eligible if they are negative for HCV-RNA.
- History of other malignancy within 2 years of study entry.
- Any condition that would, in the investigator's judgment, interfere with full participation in the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment Group A
Treatment Group B
Arm Description
Participants will be administered with parsaclisib in combination with investigator choice of rituximab or obinutuzumab.
Participants will be administered with placebo in combination with investigator choice of rituximab or obinutuzumab
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS) in R/R FL and MZL participants
Defined as the time from the date of randomization until the first documented disease progression as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014) or death from any cause, whichever occurs first.
Secondary Outcome Measures
Progression Free Survival (PFS) in R/R FL participants
Defined as the time from the date of randomization until the first documented disease progression as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014) or death from any cause, whichever occurs first.
Overall Response Rate (ORR)
Defined as the proportion of participants with a CR or PR as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014).
Overall Survival (OS)
Defined as the time from the date of randomization until death from any cause.
Progression Free Survival (PFS) in R/R MZL participants
Defined as the time from the date of randomization until the first documented disease progression as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014) or death from any cause, whichever occurs first.
Complete Response Rate (CRR)
Defined as the proportion of participants with a CR as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014).
Duration of Response (DOR)
Defined as the time from the date of first documented evidence of CR or PR until the first documented disease progression or death from any cause, whichever occurs first, among participants who achieve an objective response as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014).
Disease Control Rate (DCR)
Defined as the proportion of participants who achieve best overall response of CR, PR, or SD (Cheson et al 2014) as determined by IRC.
Event Free Survival (EFS)
Defined as the time from the date of randomization to the first documented disease progression as determined by radiographic disease assessment provided by IRC, the initiation of a new antilymphoma therapy, or death from any cause, whichever occurs first.
Time To Next antiLymphoma Therapy (TTNLT)
Defined as the time from the date of randomization to the first documented administration of a new antilymphoma therapy.
Progression-Free Survival on next antilymphoma therapy (PFS2)
Defined as the time from the date of randomization to the first documented disease progression as reported by the investigator after the initiation of a new antilymphoma therapy, death from any cause, or start of a third antilymphoma therapy since randomization in the study, whichever occurs first.
Number of Treatment Emergent Adverse Events (TEAE's)
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04796922
Brief Title
To Evaluate Efficacy and Safety of Parsaclisib Plus Either Rituximab or Obinutuzumab in R/R Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL) (CITADEL-302)
Official Title
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Parsaclisib Plus Investigator's Choice of Either Rituximab or Obinutuzumab in Participants With Relapsed or Refractory Follicular Lymphoma and Marginal Zone Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Withdrawn
Why Stopped
This study was withdrawn due to a business decision.
Study Start Date
December 30, 2022 (Anticipated)
Primary Completion Date
December 20, 2028 (Anticipated)
Study Completion Date
August 25, 2032 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study of parsaclisib plus investigator's choice of either rituximab or obinutuzumab versus placebo plus investigator's choice of rituximab or obinutuzumab for the treatment of participants with R/R FL or MZL. The Participants will be stratified in a 1:1 randomization ratio by investigator's choice of rituximab or obinutuzumab prior to randomization, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (MZL or FL) .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphoma ( FL), Marginal Zone Lymphoma (MZL)
Keywords
parsaclisib, Relapsed/Refractory, obinutuzumab, rituximab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
double blinded
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group A
Arm Type
Experimental
Arm Description
Participants will be administered with parsaclisib in combination with investigator choice of rituximab or obinutuzumab.
Arm Title
Treatment Group B
Arm Type
Placebo Comparator
Arm Description
Participants will be administered with placebo in combination with investigator choice of rituximab or obinutuzumab
Intervention Type
Drug
Intervention Name(s)
parsaclisib
Other Intervention Name(s)
INCB050465
Intervention Description
parsaclisib will be administered once daily at 20 mg for 8 weeks followed by 2.5 mg once daily.
Intervention Type
Drug
Intervention Name(s)
rituximab
Intervention Description
rituximab will be administered intravenously on select days as per protocol.
Intervention Type
Drug
Intervention Name(s)
obinutuzumab
Intervention Description
obinutuzumab will be administered intravenously on select days as per protocol.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) in R/R FL and MZL participants
Description
Defined as the time from the date of randomization until the first documented disease progression as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014) or death from any cause, whichever occurs first.
Time Frame
62 months
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS) in R/R FL participants
Description
Defined as the time from the date of randomization until the first documented disease progression as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014) or death from any cause, whichever occurs first.
Time Frame
62 months
Title
Overall Response Rate (ORR)
Description
Defined as the proportion of participants with a CR or PR as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014).
Time Frame
62 months
Title
Overall Survival (OS)
Description
Defined as the time from the date of randomization until death from any cause.
Time Frame
10 years
Title
Progression Free Survival (PFS) in R/R MZL participants
Description
Defined as the time from the date of randomization until the first documented disease progression as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014) or death from any cause, whichever occurs first.
Time Frame
62 months
Title
Complete Response Rate (CRR)
Description
Defined as the proportion of participants with a CR as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014).
Time Frame
62 months
Title
Duration of Response (DOR)
Description
Defined as the time from the date of first documented evidence of CR or PR until the first documented disease progression or death from any cause, whichever occurs first, among participants who achieve an objective response as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014).
Time Frame
62 months
Title
Disease Control Rate (DCR)
Description
Defined as the proportion of participants who achieve best overall response of CR, PR, or SD (Cheson et al 2014) as determined by IRC.
Time Frame
62 months
Title
Event Free Survival (EFS)
Description
Defined as the time from the date of randomization to the first documented disease progression as determined by radiographic disease assessment provided by IRC, the initiation of a new antilymphoma therapy, or death from any cause, whichever occurs first.
Time Frame
62 months
Title
Time To Next antiLymphoma Therapy (TTNLT)
Description
Defined as the time from the date of randomization to the first documented administration of a new antilymphoma therapy.
Time Frame
62 months
Title
Progression-Free Survival on next antilymphoma therapy (PFS2)
Description
Defined as the time from the date of randomization to the first documented disease progression as reported by the investigator after the initiation of a new antilymphoma therapy, death from any cause, or start of a third antilymphoma therapy since randomization in the study, whichever occurs first.
Time Frame
62 months
Title
Number of Treatment Emergent Adverse Events (TEAE's)
Description
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Time Frame
62 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female participants aged 18 years or older (Japan, aged 20 years or older).
Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL
Prior systemic treatment with at least 1 anti-CD20 mAb (either as monotherapy or in combination as chemoimmunotherapy)
Documented disease that has relapsed or progressed or was refractory after the most recent prior systemic therapy. Note: Participants must not be refractory to anti-CD20 mAb
Radiographically (CT, MRI) measurable lymphadenopathy per the Lugano criteria for response assessment (Cheson et al 2014).
ECOG PS of 0 to 2
Adequate organ functions including hematopoiesis, liver, and kidney
Willingness to avoid pregnancy or fathering children
Exclusion Criteria:
Women who are pregnant or breastfeeding.
Known histological transformation from indolent NHL to an aggressive NHL (eg, diffuse large B-cell lymphoma).
Presence of CNS lymphoma (either primary or secondary) or leptomeningeal disease.
Prior treatment with PI3K inhibitors.
Inadequate washout of immunosuppressive therapy, anticancer medications and investigational drugs.
Significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, GI, endocrine, pulmonary, neurological, cerebral, cardiac, infectious, or psychiatric disease.
Known HIV infection.
HBV or HCV infection: Participants positive for HBsAg or anti-HBc will be eligible if they are negative for HBV-DNA; these participants must receive prophylactic antiviral therapy. Participants positive for HCV antibody will be eligible if they are negative for HCV-RNA.
History of other malignancy within 2 years of study entry.
Any condition that would, in the investigator's judgment, interfere with full participation in the study.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency
Learn more about this trial
To Evaluate Efficacy and Safety of Parsaclisib Plus Either Rituximab or Obinutuzumab in R/R Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL) (CITADEL-302)
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