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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03424122
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : July 20, 2020
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 : June 30, 2021
Estimated Study Completion Date : June 30, 2021


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Show Show 21 study locations
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    
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: July 20, 2020
Last Verified: July 2020
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