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

Status: Active

Description

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

Eligibility 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.

Locations & Contacts

North Carolina

Durham
Duke University Medical Center
Status: Active
Name Not Available

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: Active
Name Not Available

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Incyte Corporation

Trial IDs

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