A Phase 2 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)

Phase 2

Completed

• Conditions: Lymphoma
• Interventions: Drug: Parsaclisib

• Registration Number: NCT02998476
• Lead Sponsor: Incyte Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-13
• Study First Submitted QC: 2016-12-15
• Study First Posted: 2016-12-20
• Study Start: 2017-03-02
• Primary Completion: 2019-02-22
• Results First Submitted: 2020-02-21
• Results First Submitted QC: 2020-04-14
• Results First Posted: 2020-04-24
• Study Completion: 2021-02-05
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-20
• Last Update Posted: 2025-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A Parsaclisib (no prior BTK inhibitor)	Parsaclisib	Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
Group B Parsaclisib (prior BTK inhibitor)	Parsaclisib	Parsaclisib in subjects who were previously treated with a BTK inhibitor.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate Based on Lugano Classification Criteria in Group A	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 Outcome Measures

Name	Time	Method
Progression-free Survival in Group A	Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months	Defined as the time from the date of the first dose of study drug until the earliest date of disease progression, as determined by radiographic disease assessment as provided by an IRC.
Overall Survival (OS) in Group A	From first dose of study drug until death by any cause; up to 26 months	Defined as the time from the date of the first dose of study drug until death by any cause.
Duration of Response in Group A	Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months	Defined as the time from first documented evidence of complete or partial response until disease progression or death from any cause among subjects who achieve an objective response as determined by IRC.
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	A TEAE is any AE either reported for the first time or worsening of a pre-existing event after the first dose of parsaclisib until 30 days after the last dose administration.

Trial Locations

Locations (70)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Banner MD Anderson Cancer Center; 🇺🇸 Gilbert, Arizona, United States

Arizona Oncology Associates, PC - HAL; 🇺🇸 Tempe, Arizona, United States

Sutter Gould Medical Foundation; 🇺🇸 Modesto, California, United States

Sharp Memorial Hospital; 🇺🇸 San Diego, California, United States

Advanced Pharma CR, LLC; 🇺🇸 Miami, Florida, United States

Asclepes Research Centers; 🇺🇸 Weeki Wachee, Florida, United States

Advocate Medical Group Niles Milwaukee Ave; 🇺🇸 Niles, Illinois, United States

Indiana BMT; 🇺🇸 Beech Grove, Indiana, United States

Parkview Research Center; 🇺🇸 Fort Wayne, Indiana, United States

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