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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

Tracking Information
First Submitted Date  ICMJE January 25, 2018
First Posted Date  ICMJE February 6, 2018
Last Update Posted Date September 13, 2019
Actual Study Start Date  ICMJE June 7, 2018
Estimated Primary Completion Date December 13, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03424122 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2018)
  • Apparent clearance of INCB050465 in combination with rituximab, bendamustine and rituximab, or ibrutinib [ Time Frame: Up to approximately 1 month. ]
    Measured to assess the plasma pharmacokinetic profile of INCB050465 in combination with rituximab, bendamustine and rituximab, and ibrutinib.
  • Apparent volume of distribution of INCB050465 in combination with rituximab, bendamustine and rituximab, or ibrutinib [ Time Frame: Up to approximately 1 month. ]
    Measured to assess the plasma pharmacokinetic profile of INCB050465 in combination with rituximab, bendamustine and rituximab, and ibrutinib.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE INCB050465 in Combination With Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE B-cell Lymphoma
Intervention  ICMJE
  • 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
  • Drug: Ibrutinib
    Ibrutinib administered orally once daily.
    Other Name: Imbruvica
Study Arms  ICMJE
  • Experimental: Treatment A
    Parsaclisib + Rituximab
    Interventions:
    • Drug: Parsaclisib
    • Drug: Rituximab
  • Experimental: Treatment B
    Parsaclisib + Bendamustine + Rituximab
    Interventions:
    • Drug: Parsaclisib
    • Drug: Rituximab
    • Drug: Bendamustine
  • Experimental: Treatment C
    Parsaclisib + Ibrutinib
    Interventions:
    • Drug: Parsaclisib
    • Drug: Ibrutinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 31, 2018)
81
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 13, 2020
Estimated Primary Completion Date December 13, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Italy,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03424122
Other Study ID Numbers  ICMJE INCB 50465-112 (CITADEL-112)
Parsaclisib ( Other Identifier: Incyte Corporation )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Incyte Corporation
Study Sponsor  ICMJE Incyte Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Cinthya Coronado, MD Incyte Corporation
PRS Account Incyte Corporation
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP