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



Status:Active, not recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:December 2016
End Date:July 2020

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A Phase 2, Multicenter, International, Open-Label, Safety and Efficacy Study of Parsaclisib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)

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.


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.
We found this trial at
9
sites
7901 Frost Street
San Diego, California 92123
858-939-3400
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Phone: 205-975-2944
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Beech Grove, Indiana
Phone: 317-528-7298
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Beech Grove, IN
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Darlinghurst, New South Wales 2010
Phone: +61293555613
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Darlinghurst,
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Fort Wayne, Indiana 46805
Phone: 260-425-6822
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Fort Wayne, IN
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Gilbert, Arizona 85234
Phone: 480-256-3421
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Gilbert, AZ
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2620 W Faidley Ave
Grand Island, Nebraska 68802
Phone: 308-398-6518
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Grand Island, NE
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Lake Success, New York 11042
Phone: 516-488-2918
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Lake Success, NY
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New Brunswick, New Jersey 08903
Phone: 732-235-6008
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New Brunswick, NJ
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