Clinical Trials /

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

NCT03424122

Description:

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.

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
  • Follicular Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: INCB 50465-112 (CITADEL-112)
  • SECONDARY ID: Parsaclisib
  • NCT ID: NCT03424122

Conditions

  • B-cell Lymphoma

Interventions

DrugSynonymsArms
ParsaclisibINCB050465Treatment A
RituximabRituxanTreatment A
BendamustineTreanda, BendekaTreatment B
IbrutinibImbruvicaTreatment C

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Treatment AExperimentalParsaclisib + Rituximab
  • Parsaclisib
  • Rituximab
Treatment BExperimentalParsaclisib + Bendamustine + Rituximab
  • Parsaclisib
  • Rituximab
  • Bendamustine
Treatment CExperimentalParsaclisib + Ibrutinib
  • Parsaclisib
  • Ibrutinib

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of treatment-emergent adverse events (TEAEs)
Time Frame:Up to approximately 12 months.
Safety Issue:
Description: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

Measure:Apparent clearance of parsaclisibin combination with rituximab, bendamustine and rituximab, or ibrutinib
Time Frame:Up to approximately 1 month.
Safety Issue:
Description:Measured to assess the plasma pharmacokinetic profile of parsaclisib in combination with rituximab, bendamustine and rituximab, and ibrutinib.
Measure:Apparent volume of distribution of parsaclisib in combination with rituximab, bendamustine and rituximab, or ibrutinib
Time Frame:Up to approximately 1 month.
Safety Issue:
Description:Measured to assess the plasma pharmacokinetic profile of parsaclisib in combination with rituximab, bendamustine and rituximab, and ibrutinib.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • Diffuse large B-cell lymphoma (DLBCL)
  • follicular lymphoma (FL)
  • marginal zone lymphoma (MZL)
  • mantle cell lymphoma (MCL)
  • phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor

Last Updated

February 11, 2020