NCT02998476CompletedPhase 2
A Phase 2, Multicenter, International, Open-Label, Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Incyte Corporation
- Enrollment
- 60
- Locations
- 70
- Primary Endpoint
- Objective Response Rate Based on Lugano Classification Criteria in Group A
Study Overview
Brief Summary
The purpose of this study is to assess the safety and efficacy of parsaclisib in subjects with relapsed or refractory diffuse large B-cell lymphoma.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eligible 19 years and older in South Korea
- •Relapsed or refractory DLBCL, which has been histologically documented, defined as having received at least 2 but no more than 5 prior treatment regimens and ineligible for high-dose chemotherapy supported by autologous stem cell transplant.
- •Must have ≥ 1 measurable lesion (≥2 cm in longest dimension) or ≥ 1 measurable extranodal lesion (≥1 cm in longest dimension) on computed tomography (CT) scan or magnetic resonance imaging (MRI).
- •Subjects must be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy or provide the most recent, available archived tumor biopsy.
- •Eastern Cooperative Oncology Group performance status 0 to 2.
Exclusion Criteria
- •Primary mediastinal (thymic) large B-cell lymphoma.
- •Known brain or central nervous system metastases or history of uncontrolled seizures.
- •Allogeneic stem cell transplant within the last 6 months, or active graft versus host disease following allogeneic transplant, or autologous stem cell transplant within the last 3 months.
- •Use or expected use during the study of any prohibited medications, including potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half lives (whichever is longer) before the first dose of study drug.
- •Prior treatment with the following:
- •Group A: Prior treatment with a selective phosphatidylinositol 3-kinase (PI3K) δ inhibitor (eg, idelalisib), a pan-PI3K inhibitor, or a BTK inhibitor (eg, ibrutinib).
- •Group B: Prior treatment with a selective PI3Kδ inhibitor (eg, idelalisib) or a pan PI3K inhibitor.
Arms & Interventions
Group A Parsaclisib (no prior BTK inhibitor)
Experimental
Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
Intervention: Parsaclisib (Drug)
Group B Parsaclisib (prior BTK inhibitor)
Experimental
Parsaclisib in subjects who were previously treated with a BTK inhibitor.
Intervention: Parsaclisib (Drug)
Outcomes
Primary Outcomes
Objective Response Rate Based on Lugano Classification Criteria in Group A
Time Frame: Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months
Defined as the percentage of subjects with a complete or partial response as defined by Lugano Classification criteria for lymphomas (Cheson et al 2014) as determined by IRC.
Secondary Outcomes
- Progression-free Survival in Group A(Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months)
- Overall Survival (OS) in Group A(From first dose of study drug until death by any cause; up to 26 months)
- Safety as Assessed by Percentage of Subjects With Adverse Events in Group A and Group B(Screening through 35 days after end of treatment, up to 42 months)
- Duration of Response in Group A(Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months)
Investigators
Study Sites (70)
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