An Open-Label Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)

• Status: Active, not recruiting
• Trial end date: 2022-07-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the objective response rate of parsaclisib treatment in subjects with relapsed or refractory follicular lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Idelalisib

Criteria

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.