Study Evaluating Safety and Efficacy of INCB050465 Combined With Bendamustine and Obinutuzumab in Relapsed or Refractory Follicular Lymphoma (CITADEL-102)
NCT ID: NCT03039114
Last Updated: 2025-08-21
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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COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2017-02-15
2021-03-30
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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Parsaclisib + Hexal and Gazyvaro
Parsaclisib
Parsaclisib at the protocol-defined starting dose administered once daily for 8 weeks followed by once weekly.
Hexal
Bendamustine 90 mg/m\^2 administered intravenously at protocol-defined timepoints.
Gazyvaro
Obinutuzumab 1000 mg by intravenous infusion at protocol-defined timepoints.
Interventions
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Parsaclisib
Parsaclisib at the protocol-defined starting dose administered once daily for 8 weeks followed by once weekly.
Hexal
Bendamustine 90 mg/m\^2 administered intravenously at protocol-defined timepoints.
Gazyvaro
Obinutuzumab 1000 mg by intravenous infusion at protocol-defined timepoints.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented CD20+ FL.
* Relapsed or refractory to any prior rituximab-containing regimen.
* Previously treated with a maximum of 4 cancer-directed treatment regimens.
* At least 1 measurable lesion \> 1.5 cm in at least 1 dimension by computed tomography or magnetic resonance imaging.
* Must be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy or provide the most recent, available archived tumor biopsy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Exclusion Criteria
* History of central nervous system lymphoma (either primary or metastatic).
* Allogeneic stem cell transplant within the last 6 months, or active graft-versus-host disease following allogeneic transplant or autologous stem cell transplant within the last 3 months before the date of the first dose of study drug administration.
* Use of any potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug.
* Prior treatment with a selective PI3Kδ inhibitor or a pan PI3K inhibitor.
* Prior treatment with bendamustine (within 12 months of the start of study treatment). Subjects with prior bendamustine treatment (\> 12 months before the start of study treatment) are eligible if they meet the following criteria:
* Did not discontinue because of tolerability concerns.
* Achieved either partial or CR to the bendamustine regimen of at least 12 months in duration before relapse/progression.
* Experienced progression following a regimen containing an alkylating agent.
* Received prior obinutuzumab.
* Received rituximab within 4 weeks of study start.
* Prior treatment-related toxicities that have not resolved to ≤ Grade 1 before the date of study drug administration except for stable chronic toxicities (≤ Grade 2) not expected to resolve (eg, stable Grade 2 peripheral neurotoxicity).
* Received any prior monoclonal antibody (except an anti-CD20 antibody) within 90 days before the date of study start.
* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (eg, subjects in whom re-administration with rituximab would be contraindicated for safety reasons).
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Fitzroy Dawkins, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Banner Health
Gilbert, Arizona, United States
University of California, San Diego
La Jolla, California, United States
University of Kansas Cancer Center
Fairway, Kansas, United States
Center for Cancer and Blood Disorders (CCBD) - Bethesda
Bethesda, Maryland, United States
Clinical Research Alliance
Lake Success, New York, United States
Froedtert & Medical College of Wisconsin & Affiliated Hospitals
Milwaukee, Wisconsin, United States
FN Ostrava / Ostrava
Ostrava, , Czechia
Aarhus University Hospital
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
The Finsen Centre, National Hospital
Copenhagen, , Denmark
Semmelweis Egyetem
Budapest, , Hungary
Centro di Riferimento Oncologico
Aviano, , Italy
Azienda Ospedaliero Universitaria Di Bologna
Bologna, , Italy
Policlinico S. Orsola-Ematologia LA Seragnoli
Bologna, , Italy
A.O. Spedali Civili
Brescia, , Italy
UO Ematologia ASST Spedali Civili
Brescia, , Italy
Hospital Germans Trias Pujol
Barcelona, , Spain
Hospital Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Countries
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Other Identifiers
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Parsaclisib
Identifier Type: OTHER
Identifier Source: secondary_id
2016-002829-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 50465-102 (CITADEL-102)
Identifier Type: -
Identifier Source: org_study_id
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