An Open-Label Study of INCB050465 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.

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.

Lead Organization
Incyte Corporation

Primary ID INCB 50465-203 (CITADEL-203)
Secondary IDs NCI-2017-01662, Parsaclisib
Clinicaltrials.gov ID NCT03126019