Description:
This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of
2 parsaclisib treatment regimens in subjects with relapsed or refractory mantle cell lymphoma
(MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.
Title
- Brief Title: A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)
- Official Title: A Phase 2, Open-Label, 2-Cohort, Multicenter Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)
Clinical Trial IDs
- ORG STUDY ID:
INCB 50465-205 (CITADEL-205)
- SECONDARY ID:
Parsaclisib
- NCT ID:
NCT03235544
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Parsaclisib | INCB050465 | Cohort 1- Parsaclisib |
Purpose
This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of
2 parsaclisib treatment regimens in subjects with relapsed or refractory mantle cell lymphoma
(MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.
Trial Arms
Name | Type | Description | Interventions |
---|
Cohort 1- Parsaclisib | Experimental | Participants who have previously received ibrutinib. | |
Cohort 2 - Parsaclisib | Experimental | Participants who have not previously received a BTK inhibitor. | |
Eligibility Criteria
Inclusion Criteria:
- Men and women, aged 18 years or older.
- Documented failure to achieve at least PR with, or documented disease progression
after, the most recent treatment regimen.
- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
Exclusion Criteria:
- History of central nervous system lymphoma (either primary or metastatic).
- Prior treatment with idelalisib, other selective PI3Kδ 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 first dose of study treatment.
- Active graft-versus-host disease.
- Liver 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective response rate |
Time Frame: | Protocol-defined timepoints throughout the treatment period, up to approximately 16 months per participant. |
Safety Issue: | |
Description: | Defined as the percentage of participants with a complete response (CR) or partial response (PR) as determined by computed tomography (CT)-based response criteria for lymphomas. |
Secondary Outcome Measures
Measure: | Duration of response |
Time Frame: | Protocol-defined timepoints throughout the treatment period, up to approximately 16 months per participant. |
Safety Issue: | |
Description: | 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. |
Measure: | Complete response rate |
Time Frame: | Protocol-defined timepoints throughout the treatment period, up to approximately 16 months per participant. |
Safety Issue: | |
Description: | Defined as the percentage of participants with a CR as defined by response criteria for lymphomas. |
Measure: | Progression-free survival |
Time Frame: | Protocol-defined timepoints throughout the treatment period, up to approximately 16 months per participant. |
Safety Issue: | |
Description: | Defined as the time from the date of the first dose of study treatment until the earliest date of disease progression or death from any cause. |
Measure: | Overall survival |
Time Frame: | Protocol-defined timepoints throughout the treatment period, up to approximately 26 months. |
Safety Issue: | |
Description: | Defined as the time from the date of the first dose of study treatment until death from any cause. |
Measure: | Best percentage change in target lesion size from baseline |
Time Frame: | Protocol-defined timepoints throughout the treatment period, up to approximately 16 months per participant. |
Safety Issue: | |
Description: | Target lesion size measured by the sum of the product of diameters of all target lesion sizes. |
Measure: | Safety and tolerability of parsaclisib as measured by adverse events (AEs) |
Time Frame: | Up to approximately 16 months per participant. |
Safety Issue: | |
Description: | An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Incyte Corporation |
Trial Keywords
- Mantle cell lymphoma
- non-Hodgkin lymphoma
- Bruton's tyrosine kinase (BTK)
- phosphatidylinositol 3-kinase (PI3K)
Last Updated
August 17, 2021