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

Completed · Phase 2

Conditions studied: Lymphoma

In brief

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.

Key facts

Study ID: NCT02998476
Run by: Incyte Corporation
People needed: 60
Starts: 2017-03-02
Expected to finish: 2021-02-05
Last updated by the study team: 2025-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

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
University of Kentucky Hospital — Lexington, Kentucky, United States
St. Agnes Hospital — Baltimore, Maryland, United States
Karmanos Cancer Institute — Detroit, Michigan, United States
St. John Hospital and Medical Center — Detroit, Michigan, United States
CHI Health - St. Francis Medical Center — Grand Island, Nebraska, United States
Summit Medical Group — Morristown, New Jersey, United States
Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
Clinical Research Alliance — Lake Success, New York, United States
Abington Memorial Hospital — Abington, Pennsylvania, United States
Utah Cancer Specialists- Network — Salt Lake City, Utah, United States
St Vincent's Hospital Sydney — Darlinghurst, New South Wales, Australia
Westmead Hospital — Westmead, New South Wales, Australia
Flinders Medical Centre — Bedford Park, South Australia, Australia
Ballarat Base Hospital — Ballarat, Victoria, Australia
Sunshine Hospital — St Albans, Victoria, Australia
University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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