Back to resultsA Study of Parsaclisib, a PI3Kδ Inhibitor, in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma (CITADEL-310)
Primary Purpose
Mantle Cell Lymphoma
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
parsaclisib
rituximab
bendamustine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Mantle Cell Lymphoma focused on measuring parsaclisib, newly diagnosed, bendamuastine, rituximab, PI3Kδ
Eligibility Criteria
Inclusion Criteria:
- Male and female participants aged 18 years or older. (Japan aged 20 years or older.)
- Have received no previous systemic anti-lymphoma therapies.
- Pathologically confirmed MCL by local laboratory.
- Histologically confirmed CD20 expression (by flow cytometry or immunohistochemistry) of the MCL cells as assessed by pathology.
- Ineligible for high-dose chemotherapy and autologous stem cell transplantation.
- Radiographically (CT, MRI) measurable lymphadenopathy per the Lugano criteria for response assessment (Cheson et al 2014).
- ECOG PS of 0 to 2.
- Willingness to avoid pregnancy or fathering children.
Exclusion Criteria:
- Presence of any lymphoma other than MCL.
- Presence of CNS lymphoma (either primary or secondary) or leptomeningeal disease.
- Requires treatment with potent inducers and inhibitors of CYP3A4
- Inadequate organ functions including hematopoiesis, liver, and kidney significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, GI, endocrine, pulmonary, neurological, cerebral, or psychiatric disease.
- History of other malignancy within 2 years of study entry.
- Known HIV infection, HBV or HCV.
- 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. Participant's positive for HCV antibody will be eligible if they are negative for HCV-RNA.
- Clinically significant cardiac disease, congestive heart failure, including unstable angina, acute myocardial infarction, or cardiac conduction issues, within 6 months of randomization.
- Abnormal ECG findings that are clinically meaningful per investigator's assessment.
- Women who are pregnant or breastfeeding
- Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Treatment Group A
Treatment group B
Arm Description
Participants will be administered parsaclisib once daily and will receive Bendamustine and Rituximab periodically for 6 months.
Participants will be administered placebo once daily and will receive Bendamustine and Rituximab periodically for 6 months.
Outcomes
Primary Outcome Measures
Progression Free Survival
Defined as the time from the date of randomization until the date of first-documented disease progression, as determined by an Independent Review Committee (IRC) based on the Lugano criteria, or death from any cause, whichever happens first.
Secondary Outcome Measures
Overall Survival
Defined as the time from the date of randomization until death from any cause.
Objective Response Rate
Defined as the proportion of participants with a Complete Response (CR) or Partial Response (PR) as determined by an IRC- provided radiographic disease assessment of response according to response criteria for lymphomas.
Complete Response Rate
Defined as the proportion of participants with a CR as determined by an IRC- provided radiographic disease assessment of response according to response criteria for lymphomas.
Duration of Response
Defined as the time from first-documented evidence of CR or PR until first documented disease progression or death from any cause, whichever happens first, among participants who achieve an objective response, as determined by radiographic disease assessment provided by an IRC.
Duration Of Complete Response
Defined as the time from the first evidence of CR to the date of first documented disease progression or death from any cause, whichever happens first, among participants who achieve a CR, as determined by radiographic disease assessment provided by an IRC.
Disease Control Rate
Defined as the proportion of participants who achieved a response of CR, PR, or Stable Disease (SD) assessed by an IRC.
Event Free Survival
Defined as the time from date of randomization to date of first documented progression, as determined by radiographic disease assessment provided by an IRC, administration of a new anti lymphoma treatment, or death from any cause, whichever happens first.
Time To Next anti-Lymphoma Treatment
Defined as the time from date of randomization to date of first documented administration of a new anti-lymphoma treatment.
Progression-Free Survival on next anti-lymphoma treatment
Defined as the time from the date of randomization to the date of first documented disease progression as reported by investigator after next anti-lymphoma treatment or death from any cause, or start of a third anti-lymphoma treatment since randomization, whichever happens first.
Treatment Emergent Adverse Events
Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study drug/treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04849715
Brief Title
A Study of Parsaclisib, a PI3Kδ Inhibitor, in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma
Acronym
CITADEL-310
Official Title
A Phase 3, Randomized, Double-Blind Study Comparing Parsaclisib, a PI3Kδ Inhibitor, in Combination With Bendamustine and Rituximab (BR), With Placebo and BR for the Treatment of Newly Diagnosed Mantle Cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
business decision; no enrolled patients
Study Start Date
March 11, 2022 (Anticipated)
Primary Completion Date
August 15, 2030 (Anticipated)
Study Completion Date
July 7, 2034 (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 BR versus placebo plus BR as first-line treatment of participants with newly diagnosed MCL.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma
Keywords
parsaclisib, newly diagnosed, bendamuastine, rituximab, PI3Kδ
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group A
Arm Type
Active Comparator
Arm Description
Participants will be administered parsaclisib once daily and will receive Bendamustine and Rituximab periodically for 6 months.
Arm Title
Treatment group B
Arm Type
Placebo Comparator
Arm Description
Participants will be administered placebo once daily and will receive Bendamustine and Rituximab periodically for 6 months.
Intervention Type
Drug
Intervention Name(s)
parsaclisib
Other Intervention Name(s)
INCB050465
Intervention Description
parsaclisib will be administered orally once daily.
Intervention Type
Drug
Intervention Name(s)
rituximab
Other Intervention Name(s)
Rituxan
Intervention Description
rituximab is administered IV on Day 1 of each 28-day cycle for 6 cycles.
Intervention Type
Drug
Intervention Name(s)
bendamustine
Other Intervention Name(s)
Bendeka, Treanda
Intervention Description
bendamustine is administered IV on Day 1 and 2 of each 28-day cycle for 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo will be administered orally once daily
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
Defined as the time from the date of randomization until the date of first-documented disease progression, as determined by an Independent Review Committee (IRC) based on the Lugano criteria, or death from any cause, whichever happens first.
Time Frame
7 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Defined as the time from the date of randomization until death from any cause.
Time Frame
10 years
Title
Objective Response Rate
Description
Defined as the proportion of participants with a Complete Response (CR) or Partial Response (PR) as determined by an IRC- provided radiographic disease assessment of response according to response criteria for lymphomas.
Time Frame
7 Years
Title
Complete Response Rate
Description
Defined as the proportion of participants with a CR as determined by an IRC- provided radiographic disease assessment of response according to response criteria for lymphomas.
Time Frame
7 Years
Title
Duration of Response
Description
Defined as the time from first-documented evidence of CR or PR until first documented disease progression or death from any cause, whichever happens first, among participants who achieve an objective response, as determined by radiographic disease assessment provided by an IRC.
Time Frame
7 Years
Title
Duration Of Complete Response
Description
Defined as the time from the first evidence of CR to the date of first documented disease progression or death from any cause, whichever happens first, among participants who achieve a CR, as determined by radiographic disease assessment provided by an IRC.
Time Frame
7 Years
Title
Disease Control Rate
Description
Defined as the proportion of participants who achieved a response of CR, PR, or Stable Disease (SD) assessed by an IRC.
Time Frame
7 Years
Title
Event Free Survival
Description
Defined as the time from date of randomization to date of first documented progression, as determined by radiographic disease assessment provided by an IRC, administration of a new anti lymphoma treatment, or death from any cause, whichever happens first.
Time Frame
7 Years
Title
Time To Next anti-Lymphoma Treatment
Description
Defined as the time from date of randomization to date of first documented administration of a new anti-lymphoma treatment.
Time Frame
7 Years
Title
Progression-Free Survival on next anti-lymphoma treatment
Description
Defined as the time from the date of randomization to the date of first documented disease progression as reported by investigator after next anti-lymphoma treatment or death from any cause, or start of a third anti-lymphoma treatment since randomization, whichever happens first.
Time Frame
7 Years
Title
Treatment Emergent Adverse Events
Description
Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study drug/treatment.
Time Frame
7 Years
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.)
Have received no previous systemic anti-lymphoma therapies.
Pathologically confirmed MCL by local laboratory.
Histologically confirmed CD20 expression (by flow cytometry or immunohistochemistry) of the MCL cells as assessed by pathology.
Ineligible for high-dose chemotherapy and autologous stem cell transplantation.
Radiographically (CT, MRI) measurable lymphadenopathy per the Lugano criteria for response assessment (Cheson et al 2014).
ECOG PS of 0 to 2.
Willingness to avoid pregnancy or fathering children.
Exclusion Criteria:
Presence of any lymphoma other than MCL.
Presence of CNS lymphoma (either primary or secondary) or leptomeningeal disease.
Requires treatment with potent inducers and inhibitors of CYP3A4
Inadequate organ functions including hematopoiesis, liver, and kidney significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, GI, endocrine, pulmonary, neurological, cerebral, or psychiatric disease.
History of other malignancy within 2 years of study entry.
Known HIV infection, HBV or HCV.
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. Participant's positive for HCV antibody will be eligible if they are negative for HCV-RNA.
Clinically significant cardiac disease, congestive heart failure, including unstable angina, acute myocardial infarction, or cardiac conduction issues, within 6 months of randomization.
Abnormal ECG findings that are clinically meaningful per investigator's assessment.
Women who are pregnant or breastfeeding
Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
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
A Study of Parsaclisib, a PI3Kδ Inhibitor, in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma
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