Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

Summary

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

Keywords

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

Eligibility

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

Locations

  • Moores UC San Diego Cancer Center accepting new patients
    San Diego California 92093 United States
  • Pacific Shores Medical Group accepting new patients
    Long Beach California 90813 United States
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010 United States
  • LAC-USC Medical Center/Kenneth Norris Jr Cancer Hospital accepting new patients
    Los Angeles California 90033 United States
  • Comprehensive Cancer Center of Nevada accepting new patients
    Las Vegas Nevada 89169 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
ID
NCT02760485
Phase
Phase 1/2
Study Type
Interventional
Last Updated
March 23, 2018