Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies
NCT ID: NCT01905813
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
121 participants
INTERVENTIONAL
2013-06-30
2026-04-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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INCB040093
INCB040093
Escalating doses starting at 100 mg every day (QD)
INCB040093 in combination with itacitinib (INCB039110)
INCB040093 + itacitinib
INCB040093 dose to be determined at completion of Part 1 of the study + itacitinib at a starting dose of 400 mg, QD with escalations planned up to 600 mg QD.
Interventions
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INCB040093
Escalating doses starting at 100 mg every day (QD)
INCB040093 + itacitinib
INCB040093 dose to be determined at completion of Part 1 of the study + itacitinib at a starting dose of 400 mg, QD with escalations planned up to 600 mg QD.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
\*Indolent / aggressive B-cell (NHL) Non- Hodgkin's Lymphoma:
EXCLUDING: Burkitt lymphoma and precursor B-lymphoblastic leukemia/lymphoma
INCLUDING: any non-Hodgkin's B-cell malignancy such as CLL and rare non-Hodgkin's B-cell subtypes such as Hairy Cell Leukemia, Waldenstrom macroglobulinemia, Mantle cell lymphoma, transformed NHL histologies, etc.
\*Hodgkin's lymphoma
* Life expectancy of 12 weeks or longer.
* Subject must have received ≥ 1 prior treatment regimen.
* The subject must not be a candidate for potentially curative therapy, including stem cell transplant.
Exclusion Criteria
* Received any approved anticancer medications within 21 days or 5 half-lives (whichever is longer) prior to receiving their first dose of study drug (42 days for nitrosoureas) EXCEPT steroids at ≤ 10 mg prednisone daily (or equivalent).
* Has any unresolved toxicity ≥ Grade 2 from previous anticancer therapy.
* Has history of brain metastases or spinal cord compression, or lymphoma involving the central nervous system.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 3.
* Received allogeneic hematopoietic stem cell transplant within the last 6 months, or has active graft versus host disease (GVHD) following allogeneic transplant, or is currently receiving immunosuppressive therapy following allogeneic transplant.
* Received autologous hematopoietic stem cell transplant within the last 3 months.
* Laboratory parameters not within the protocol-defined range.
* Current or recent history (\<30 days prior to screening and/or \<45 days prior to dosing) of a clinically meaningful bacterial, fungal, parasitic or mycobacterial infection.
* Current clinically active viral infection.
* Known history of infection with the human immunodeficiency virus (HIV).
* History of active hepatitis or positive serology for hepatitis.
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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Birmingham, Alabama, United States
Jacksonville, Florida, United States
Ann Arbor, Michigan, United States
Rochester, Minnesota, United States
New York, New York, United States
Rochester, New York, United States
Countries
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References
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Phillips TJ, Forero-Torres A, Sher T, Diefenbach CS, Johnston P, Talpaz M, Pulini J, Zhou L, Scherle P, Chen X, Barr PM. Phase 1 study of the PI3Kdelta inhibitor INCB040093 +/- JAK1 inhibitor itacitinib in relapsed/refractory B-cell lymphoma. Blood. 2018 Jul 19;132(3):293-306. doi: 10.1182/blood-2017-10-812701. Epub 2018 Apr 25.
Related Links
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Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies
Other Identifiers
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INCB 40093-102
Identifier Type: -
Identifier Source: org_study_id