Last updated on March 2019

An Open-Label, Dose-Finding, and Cohort-Expansion Phase 1 Study Evaluating Safety and Efficacy of INCB050465 in Combination With Bendamustine and Obinutuzumab in Subjects With Relapsed or Refractory Follicular Lymphoma (CITADEL-102)

Are you eligible to participate in this study?

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

  • Conditions: follicular lymphoma | Follicular Lymphoma
  • Age: 18 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Aged 18 or older.
  • Histologically confirmed FL.
  • Documented CD20+ FL.
  • Relapsed or refractory to any prior rituximab-containing regimen.
  • Previously treated with a maximum of 4 cancer-directed treatment regimens.
  • At least 1 measurable lesion > 1.5 cm in at least 1 dimension by computed tomography (CT) or magnetic resonance imaging (MRI).
  • Subjects must be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy or provide the most recent, available archived tumor biopsy.
  • ECOG performance status of 0 to 2.

Exclusion Criteria:

  • Clinical evidence of transformation to a more aggressive subtype of lymphoma or Grade 3B FL.
  • History of central nervous system lymphoma (either primary or metastatic).
  • Allogeneic stem cell transplant within the last 6 months, or active graft-versus-host disease following allogeneic transplant or autologous stem cell transplant within the last 3 months before the date of the first dose of study drug administration.
  • Use of any potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug.
  • Prior treatment with a selective phosphatidylinositol 3-kinase (PI3K) d inhibitor or a pan-PI3K inhibitor.
  • Prior treatment with bendamustine (within 12 months of the start of study treatment).
  • Received prior obinutuzumab.
  • Received rituximab within 4 weeks of study start.
  • Prior treatment-related toxicities that have not resolved to = Grade 1 before the date of study drug administration date except for stable chronic toxicities (= Grade 2) not expected to resolve (eg, stable Grade 2 peripheral neurotoxicity).
  • Received any prior monoclonal antibody (except an anti-CD20 antibody) within 90 days before the date of study start.
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (eg, subjects in whom re-administration with rituximab would be contraindicated for safety reasons).

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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