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INCB050465 in Combination With Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)

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ClinicalTrials.gov Identifier: NCT03424122
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of parsaclisib when combined with rituximab, bendamustine and rituximab, or ibrutinib in participants with relapsed or refractory B-cell lymphoma.

Condition or disease Intervention/treatment Phase
B-cell Lymphoma Drug: Parsaclisib Drug: Rituximab Drug: Bendamustine Drug: Ibrutinib Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Dose-Finding Study of INCB050465 in Combination With Investigator Choice of Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)
Actual Study Start Date : June 7, 2018
Estimated Primary Completion Date : December 13, 2019
Estimated Study Completion Date : December 13, 2020


Arm Intervention/treatment
Experimental: Treatment A
Parsaclisib + Rituximab
Drug: Parsaclisib
Parsaclisib administered orally once daily for 8 weeks followed by once weekly.
Other Name: INCB050465

Drug: Rituximab
Rituximab administered intravenously at the protocol-defined dose regimen according to treatment group.
Other Name: Rituxan

Experimental: Treatment B
Parsaclisib + Bendamustine + Rituximab
Drug: Parsaclisib
Parsaclisib administered orally once daily for 8 weeks followed by once weekly.
Other Name: INCB050465

Drug: Rituximab
Rituximab administered intravenously at the protocol-defined dose regimen according to treatment group.
Other Name: Rituxan

Drug: Bendamustine
Bendamustine administered intravenously on Days 1 and 2 of each cycle for up to 6 cycles.
Other Name: Treanda, Bendeka

Experimental: Treatment C
Parsaclisib + Ibrutinib
Drug: Parsaclisib
Parsaclisib administered orally once daily for 8 weeks followed by once weekly.
Other Name: INCB050465

Drug: Ibrutinib
Ibrutinib administered orally once daily.
Other Name: Imbruvica




Primary Outcome Measures :
  1. Number of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to approximately 12 months. ]
    A TEAE is any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment.


Secondary Outcome Measures :
  1. Apparent clearance of parsaclisibin combination with rituximab, bendamustine and rituximab, or ibrutinib [ Time Frame: Up to approximately 1 month. ]
    Measured to assess the plasma pharmacokinetic profile of parsaclisib in combination with rituximab, bendamustine and rituximab, and ibrutinib.

  2. Apparent volume of distribution of parsaclisib in combination with rituximab, bendamustine and rituximab, or ibrutinib [ Time Frame: Up to approximately 1 month. ]
    Measured to assess the plasma pharmacokinetic profile of parsaclisib in combination with rituximab, bendamustine and rituximab, and ibrutinib.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women, aged 18 years or older on the day of signing the Informed Consent Form (ICF).
  • Histologically confirmed indolent/aggressive DLBCL, FL, MZL, or MCL.
  • Participants with DLBCL, MZL or MCL must have received at least 1 prior line of systemic therapy with documented progression or documented failure to achieve CR or PR after the most recent systemic treatment regimen.
  • Participants with FL must have received at least 2 prior lines of systemic therapy with documented progression or documented failure to achieve CR or PR after the most recent systemic treatment regimen.
  • Ineligible for stem cell transplant.
  • Participants with DLBCL must have failed or refused stem cell transplantation or failed first-line salvage therapy if ineligible for transplantation.
  • Must be willing to undergo an incisional or excisional lymph node or tissue biopsy or to provide a lymph node or tissue biopsy from the most recent available archival tissue.
  • Life expectancy of > 3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 (see Appendix D).
  • Willingness to avoid pregnancy or fathering a child.
  • Ability to comprehend and willingness to sign an ICF

Exclusion Criteria:

  • Evidence of transformed non-Hodgkin lymphoma histologies (with the exception of FL).
  • Histologically confirmed rare non-Hodgkin B-cell subtypes.
  • History of or central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
  • Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K inhibitor.
  • For participants to be treated with bendamustine (Treatment B), prior treatment with bendamustine (within 12 months of the start of study treatment). Participants 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 response (PR) or complete response (CR) to the bendamustine regimen of at least 12 months in duration before relapse/progression.
    • Experienced progression following a regimen containing an alkylating agent.
  • For participants to be treated with ibrutinib (Treatment C), prior treatment with a Bruton's tyrosine kinase (BTK) inhibitor.
  • Allogeneic stem cell transplant within the last 6 months or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment.
  • Active graft-versus-host disease following allogeneic transplant.
  • Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03424122


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 globalmedinfo@incyte.com

Locations
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United States, Arizona
University of Arizona Cancer Center- Out Pt Recruiting
Tucson, Arizona, United States, 85719
Contact: Study Coordinator    520-626-5683      
United States, Indiana
Indiana Blood and Marrow Transplantation Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Study Coordinator    317-528-7298      
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Study Coordinator    702-952-3400      
United States, Texas
Texas Oncology Recruiting
Austin, Texas, United States, 78705
Contact: Study Coordinator    512-421-4100      
Baylor Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Study Coordinator    214-370-1000      
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Study Coordinator    713-798-2950      
Smith Clinic Recruiting
Houston, Texas, United States, 77054
Contact: Study Coordinator    713-798-2950      
Cancer Care Centers of South Texas Recruiting
San Antonio, Texas, United States, 78217
Contact: Study Coordinator    210-656-7177      
Texas Oncology San Antonio Recruiting
San Antonio, Texas, United States, 78240
Contact: Study Coordinator    210-595-5300      
Italy
Asst Spedali Civili Di Brescia Recruiting
Brescia, Italy, 25123
Contact: Study Coordinator    +390303998571      
Azienda Ospedaliera San Gerardo DI Monza Recruiting
Monza, Italy, 20052
Contact: Study Coordinator    +390392339553      
Azienda Ospedaliera Universitaria Pisana Recruiting
Pisa, Italy, 56126
Contact: Study Coordinator    +39 050993025      
Ospedale Delle Croci - Ematologia Ravenna Recruiting
Ravenna, Italy, 48121
Contact: Study Coordinator    +39 057 758 6798      
Spain
Hospital Germans Trias I Pujol Recruiting
Badalona, Spain, 08916
Contact: Study Coordinator    +34 93 497 8728      
Hospital General Universitari Vall D Hebron Recruiting
Barcelona, Spain, 08035
Contact: Study Coordinator    +34 93 274 6100      
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Study Coordinator    34 93 238 1661      
Fundacion Jimenez Diaz University Hospital Recruiting
Madrid, Spain, 28040
Contact: Study Coordinator    3491550480      
Hospital Universitario HM Sanchinarro Recruiting
Madrid, Spain, 28050
Contact: Study Coordinators    34923291100      
Hospital Clinico Universitario De Salamanca Recruiting
Salamanca, Spain, 37007
Contact: Study Coordinator    +34 923291100      
Hospital Universitario Virgen Del Rocio Recruiting
Sevilla, Spain, 41013
Contact: Study Coordinator    (346) 393-4839      
Hospital Universitari Y Politecnic La Fe Recruiting
Valencia, Spain, 46026
Contact: Study Coordinator    +34 96 1244 190      
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Cinthya Coronado, MD Incyte Corporation

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03424122     History of Changes
Other Study ID Numbers: INCB 50465-112 (CITADEL-112)
Parsaclisib ( Other Identifier: Incyte Corporation )
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Diffuse large B-cell lymphoma (DLBCL)
follicular lymphoma (FL)
marginal zone lymphoma (MZL)
mantle cell lymphoma (MCL)
phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor
Additional relevant MeSH terms:
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Bendamustine Hydrochloride
Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action