Last updated on March 2019

A Phase 2, Multicenter, Open-Label, Randomized Study Comparing INCB050465, a PI3Kd Inhibitor, to Idelalisib in Relapsed or Refractory Follicular Lymphoma

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 years or older (except in South Korea, aged 19 or older).
  • Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (NHL) (FL) 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.
  • Subjects 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.
  • 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 phosphatidylinositol 3-kinase (PI3K) d 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 randomization.
  • Active graft-versus-host disease.
  • Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation: HBV DNA and HCV RNA must be undetectable.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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