A Study of Itacitinib (INCB039110) in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
NCT ID: NCT02760485
Last Updated: 2023-06-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
33 participants
INTERVENTIONAL
2016-12-29
2022-06-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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itacitinib + ibrutinib
itacitinib
Phase 1 will evaluate itacitinib at the protocol-specified starting dose, with a possible increase or decrease depending on tolerability. Phase 2 will evaluate the recommended dose determined in Phase 1.
ibrutinib
Interventions
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itacitinib
Phase 1 will evaluate itacitinib at the protocol-specified starting dose, with a possible increase or decrease depending on tolerability. Phase 2 will evaluate the recommended dose determined in Phase 1.
ibrutinib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Langmuir, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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INCB 39110-206
Identifier Type: -
Identifier Source: org_study_id
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