A Phase 1/2, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 and Itacitinib in Subjects With Previously Treated B-Cell Malignancies (CITADEL-101)
NCT ID: NCT02018861
Last Updated: 2023-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
88 participants
INTERVENTIONAL
2016-09-22
2021-04-12
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
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Parsaclisib 5 mg QD
Parsaclisib 5 milligrams (mg) as an oral tablet once a day (QD) in 21-day treatment cycles
Parsaclisib
Parsaclisib 10 mg QD
Parsaclisib 10 mg as oral tablets QD in 21-day treatment cycles
Parsaclisib
Parsaclisib 15 mg QD
Parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles
Parsaclisib
Parsaclisib 20 mg QD
Parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles
Parsaclisib
Parsaclisib 30 mg QD
Parsaclisib 30 mg as oral tablets QD in 21-day treatment cycles
Parsaclisib
Parsaclisib 45 mg QD
Parsaclisib 45 mg as oral tablets QD in 21-day treatment cycles
Parsaclisib
Parsaclisib 20 mg + itacitinib (INCB039110) 300 mg
Parsaclisib 20 mg as oral tablets QD and itacitinib (INCB039110) 300 mg as oral tablets QD in 21-day treatment cycles
Parsaclisib
Itacitinib
Parsaclisib 30 mg + itacitinib (INCB039110) 300 mg
Parsaclisib 30 mg as oral tablets QD and itacitinib (INCB039110) 300 mg as oral tablets QD in 21-day treatment cycles
Parsaclisib
Itacitinib
Parsaclisib 15 mg QD + R-ICE
Parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 milligrams per meters squared (mg/m\^2) intravenously (IV) on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m\^2 IV on Day 3 of each cycle, carboplatin area under the curve (AUC) = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m\^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration
Parsaclisib
Rituximab
Ifosfamide
Carboplatin
Etoposide
Parsaclisib 20 mg QD + R-ICE
20 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 mg/m\^2 IV on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m\^2 IV on Day 3 of each cycle, carboplatin AUC = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m\^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
Parsaclisib
Rituximab
Ifosfamide
Carboplatin
Etoposide
Interventions
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Parsaclisib
Itacitinib
Rituximab
Ifosfamide
Carboplatin
Etoposide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Indolent / aggressive B-cell non-Hodgkin's lymphoma (NHL)
* EXCLUDING: Burkitt's lymphoma and precursor B lymphoblastic leukemia/lymphoma
* INCLUDING: any non-Hodgkin's B cell malignancy such as chronic lymphocytic leukemia (CLL) and rare non-Hodgkin's B- cell subtypes such as hairy cell leukemia, Waldenström macroglobulinemia (WM), mantle cell leukemia (MCL), and transformed NHL histologies
2. Hodgkin's lymphoma (HL)
* Life expectancy of 12 weeks or longer
* Subject must have received ≥ 1 prior treatment regimen(s)
* The subject must not be a candidate for potentially curative therapy including hematopoietic stem cell transplantation, except where one of the standard therapy regimen combinations may be used prior to transplantation per standard medical practice
Exclusion Criteria
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 3 (≥ 2 during dose escalation)
* Received allogeneic hematopoietic stem cell transplant within the last 6 months, or has active graft versus host disease (GVHD) following allogeneic transplant, or currently receiving immunosuppressive therapy following allogeneic transplant
* Received autologous hematopoietic stem cell transplant within the last 3 months
* Inadequate marrow reserve assessed by hematologic laboratory parameters
* Inadequate renal or liver function
* Known HIV infection, or hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or at risk for HBV reactivation
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Claudia Corrado, M.D.
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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University of Alabama At Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
University of Michigan Cancer Center
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Nyu Langone Laura and Isaac Perlmutter Cancer Center
New York, New York, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Greenville Health System Cancer Institute
Greenville, South Carolina, United States
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Countries
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References
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Forero-Torres A, Ramchandren R, Yacoub A, Wertheim MS, Edenfield WJ, Caimi P, Gutierrez M, Akard L, Escobar C, Call J, Persky D, Iyer S, DeMarini DJ, Zhou L, Chen X, Dawkins F, Phillips TJ. Parsaclisib, a potent and highly selective PI3Kdelta inhibitor, in patients with relapsed or refractory B-cell malignancies. Blood. 2019 Apr 18;133(16):1742-1752. doi: 10.1182/blood-2018-08-867499. Epub 2019 Feb 25.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Plain Language Summary of Results
Other Identifiers
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Parsaclisib
Identifier Type: OTHER
Identifier Source: secondary_id
INCB 50465-101 (CITADEL-101)
Identifier Type: -
Identifier Source: org_study_id
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