An Open-Label Study of Parsaclisib in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)
Status: | Recruiting |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/23/2019 |
Start Date: | June 29, 2017 |
End Date: | October 2021 |
Contact: | Incyte Corporation Call Center (US) |
Email: | medinfo@incyte.com |
Phone: | 1.855.463.3463 |
A Phase 2, Multicenter, Open-Label Study of Parsaclisib, a PI3Kδ Inhibitor in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)
The purpose of this study is to assess the objective response rate of parsaclisib treatment
in subjects with relapsed or refractory follicular lymphoma.
in subjects with relapsed or refractory follicular lymphoma.
Inclusion Criteria:
- Aged 18 years or older.
- Histologically confirmed, relapsed or refractory, follicular B-cell NHL (follicular
lymphoma) Grade 1, 2, and 3a.
- Ineligible for hematopoietic stem cell transplant.
- Must have been treated with at least 2 prior systemic therapies.
- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined
as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest dimension and ≥
1.0 cm in the longest perpendicular dimension as assessed by computed tomography or
magnetic resonance imaging.
- Must be willing to undergo an incisional, excisional, or core needle lymph node or
tissue biopsy or provide a lymph node or tissue biopsy from the most recent available
archival tissue.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
Exclusion Criteria:
- Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.
- History of central nervous system lymphoma (either primary or metastatic).
- Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K
inhibitor.
- Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).
- Allogeneic stem cell transplant within the last 6 months, or autologous stem cell
transplant within the last 3 months before the date of study treatment administration.
- Active graft-versus-host disease.
- Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be
eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody
will be eligible if they are negative for HCV-RNA.
We found this trial at
22
sites
Philadelphia, Pennsylvania 19104
Phone: 215-615-4312
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Albury, New South Wales
Phone: 61 2 6064 1496
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1100 Charlotte Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Phone: 615-524-4469
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825 Eastlake Avenue East
Seattle, Washington 98109
Seattle, Washington 98109
Phone: 206-606-6721
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15111 Whittier Boulevard
Whittier, California 90603
Whittier, California 90603
Phone: 562-693-4477
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