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 |
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.
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
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
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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2620 W Faidley Ave
Grand Island, Nebraska 68802
Grand Island, Nebraska 68802
Phone: 308-398-6518
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