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



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/18/2018
Start Date:December 2016
End Date:July 2019
Contact:Incyte Corporation Call Center
Phone:1.855.463.3463

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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

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)


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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
We found this trial at
21
sites
Houston, Texas 77030
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Ann Arbor, Michigan 48109
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Augusta, Georgia 30912
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Baltimore, Maryland 21201
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Baltimore, MD
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Billings, Montana 59102
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Billings, MT
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665 Elm Street
Buffalo, New York 14263
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Buffalo, NY
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Danville, PA
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Duarte, CA
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401 West Greenlawn Avenue
Lansing, Michigan 48910
(517) 975-9500
Michigan State University - Breslin Cancer Center This busy clinic provides care to thousands of...
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Lansing, MI
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Las Vegas, Nevada 89169
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Las Vegas, NV
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180 White Road
Little Silver, New Jersey 07739
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Little Silver, NJ
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Long Beach, California 90813
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Long Beach, CA
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2051 Marengo St
Los Angeles, California 90033
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Los Angeles, CA
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Miami Beach, Florida 33140
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Miami Beach, FL
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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2920 South Meridian
Puyallup, Washington 98373
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Puyallup, WA
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3855 Health Sciences Drive
San Diego, California 92093
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San Diego, CA
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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4126 North Holland Sylvania Road
Toledo, Ohio 43623
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Toledo, OH
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12697 East 51st Street South
Tulsa, Oklahoma 74146
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Tulsa, OK
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