Last updated on May 2018

A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: follicular lymphoma | Lymphoma
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Men and women, aged 18 or older (except in South Korea, aged 19 or older).
  • Histologically confirmed marginal zone lymphoma, including extranodal, nodal, and splenic subtypes.
  • Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of 1 lesion that measures > 1.5 cm in the longest transverse diameter and 1.0 cm in the longest perpendicular diameter.
  • Participants with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed.
  • Participants must be willing to undergo an incisional or excisional lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
  • Eastern Cooperative Oncology Group performance status 0 to 2.

Exclusion Criteria:

  • Evidence of diffuse large B-cell transformation.
  • History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
  • Prior treatment with idelalisib, other selective PI3K inhibitors, or a pan-PI3K inhibitor.
  • Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment.
  • Active graft versus host disease.
  • Liver disease: Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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