A Study of Itacitinib (INCB039110) in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Completed · Phase 1/Phase 2

Conditions studied: Lymphoma

In brief

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)

Key facts

Study ID

NCT02760485

Run by

Incyte Corporation

People needed

33

Starts

2016-12-29

Expected to finish

2022-06-06

Last updated by the study team

2023-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• City of Hope National Medical Center — Duarte, California, United States
• Pacific Shores Medical Group — Long Beach, California, United States
• LAC-USC Medical Center/Kenneth Norris Jr Cancer Hospital — Los Angeles, California, United States
• Moores UC San Diego Cancer Center — San Diego, California, United States
• Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States
• Georgia Regents Research Institute — Augusta, Georgia, United States
• University of Maryland Cancer Center — Baltimore, Maryland, United States
• University of Michigan Cancer Center — Ann Arbor, Michigan, United States
• Michigan State University Breslin Cancer Center — Lansing, Michigan, United States
• St Vincent Frontier Cancer Center — Billings, Montana, United States
• Comprehensive Cancer Center of Nevada — Las Vegas, Nevada, United States
• Regional Cancer Center Associates, LLC — Little Silver, New Jersey, United States
• Roswell Cancer Center — Buffalo, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Toledo Clinic Cancer Centers — Toledo, Ohio, United States
• Tulsa Cancer Center — Tulsa, Oklahoma, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States
• Houston Methodist Cancer Center — Houston, Texas, United States
• Northwest Medical Specialists & Research Institute — Puyallup, Washington, United States

Full record on ClinicalTrials.gov

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