for people ages 18 years and up (full criteria)
study started
estimated completion



The purpose of this study is to evaluate the safety/tolerability and efficacy of itacitinib in combination with ibrutinib in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

Official Title

An Open-Label Phase 1/2 Study of Itacitinib (INCB039110) in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma


Lymphoma Diffuse large B-cell lymphoma Relapsed Diffuse large B-cell lymphoma Refractory Diffuse large B-cell lymphoma activated B cell germinal center B-cell non-Hodgkin lymphoma JAK1 inhibitor Bruton's tyrosine kinase (BTK) inhibitor Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse itacitinib ibrutinib itacitinib + ibrutinib


You can join if…

Open to people ages 18 years and up

  • Histologically documented diagnosis of DLBCL.
  • Phase 1: any DLBCL subtype.
  • Phase 2: activated B-cell or unclassifiable subtypes confirmed by immunohistochemistry using the Hans algorithm
  • Relapsed or refractory DLBCL, defined as having received at least 1 but no more than 3 prior treatment regimens and ineligible for high-dose chemotherapy/autologous stem cell transplant.
  • Fluorodeoxyglucose-avid disease (based on local evaluation) per the Lugano Classification. Fluorodeoxyglucose-avid disease is defined as disease with a 5-point scale score of 4 or 5.
  • Archived tumor tissue (block or 15-20 unstained slides) available, or be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy (or, in less accessible lymph nodes, 4 to 8 core biopsies).
  • At least 1 measurable (≥ 2 cm in longest dimension) lesion on CT scan or magnetic resonance imaging (MRI).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

You CAN'T join if...

  • Transformed DLBCL or DLBCL with coexistent histologies (eg, follicular or mucosa-associated lymphoid tissue lymphoma).
  • Primary mediastinal (thymic) large B-cell lymphoma.
  • Known central nervous system lymphoma (either primary or metastatic).
  • Allogeneic stem cell transplant within the previous 6 months, or active graft versus host disease following allogeneic transplant.
  • Use of immunosuppressive therapy within 28 days of starting study treatment. Immunosuppressive therapy includes but is not limited to cyclosporine A, tacrolimus, or high-dose corticosteroids. Subjects receiving corticosteroids must be at a dose level ≤ 10 mg/day within 7 days of initiating study treatment.
  • Prior or concurrent therapy with a Janus kinase inhibitor or Bruton's tyrosine kinase inhibitor


  • Moores UC San Diego Cancer Center
    San Diego California 92093 United States
  • LAC-USC Medical Center/Kenneth Norris Jr Cancer Hospital
    Los Angeles California 90033 United States
  • Pacific Shores Medical Group
    Long Beach California 90813 United States
  • City of Hope National Medical Center
    Duarte California 91010 United States


in progress, not accepting new patients
Start Date
Completion Date
Incyte Corporation
Phase 1/2 research study
Study Type
At least 33 people participating
Last Updated