Clinical Trials /

An Open-Label Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)

NCT03126019

Description:

The purpose of this study is to assess the objective response rate of parsaclisib treatment in subjects with relapsed or refractory follicular lymphoma.

Related Conditions:
  • Follicular Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: An Open-Label Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)
  • Official Title: A Phase 2, Multicenter, Open-Label Study of INCB050465, a PI3Kδ Inhibitor in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)

Clinical Trial IDs

  • ORG STUDY ID: INCB 50465-203 (CITADEL-203)
  • SECONDARY ID: Parsaclisib
  • NCT ID: NCT03126019

Conditions

  • Lymphoma

Interventions

DrugSynonymsArms
ParsaclisibINCB050465Group B
ParsaclisibINCB050465Group A

Purpose

The purpose of this study is to assess the objective response rate of parsaclisib treatment in subjects with relapsed or refractory follicular lymphoma.

Trial Arms

NameTypeDescriptionInterventions
Group AExperimentalParsaclisib once daily (QD) for 8 weeks followed by Parsaclisib once weekly
  • Parsaclisib
Group BExperimentalParsaclisib QD
  • Parsaclisib

Eligibility Criteria

        Inclusion Criteria:

          -  Aged 18 years or older.

          -  Histologically confirmed, relapsed or refractory, follicular B-cell NHL (follicular
             lymphoma) Grade 1, 2, and 3a.

          -  Ineligible for hematopoietic stem cell transplant.

          -  Must have been treated with at least 2 prior systemic therapies.

          -  Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined
             as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest dimension and ≥
             1.0 cm in the longest perpendicular dimension as assessed by computed tomography or
             magnetic resonance imaging.

          -  Must be willing to undergo an incisional, excisional, or core needle lymph node or
             tissue biopsy or provide a lymph node or tissue biopsy from the most recent available
             archival tissue.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

        Exclusion Criteria:

          -  Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.

          -  History of central nervous system lymphoma (either primary or metastatic).

          -  Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K
             inhibitor.

          -  Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).

          -  Allogeneic stem cell transplant within the last 6 months, or autologous stem cell
             transplant within the last 3 months before the date of study treatment administration.

          -  Active graft-versus-host disease.

          -  Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be
             eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody
             will be eligible if they are negative for HCV-RNA.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate with parsaclisib based on Lugano classification response criteria
Time Frame:Weeks 8, 16, and 24, then every 12 weeks through Week 96, and then every 24 Weeks thereafter until disease progression, up to approximately 12 months.
Safety Issue:
Description:Defined as the percentage of subjects with a complete response (CR) or partial response (PR) as determined by an independent review committee.

Secondary Outcome Measures

Measure:Complete response rate with parsaclisib based on Lugano classification response criteria
Time Frame:Up to approximately 12 months per subject
Safety Issue:
Description:Defined as the percentage of subjects with a CR as determined by an independent review committee.
Measure:Duration of response
Time Frame:Up to approximately 24 months per subject
Safety Issue:
Description:Defined as the time from first documented evidence of CR or PR until disease progression or death from any cause among subjects who achieve an objective response.
Measure:Progression-free survival with parsaclisib
Time Frame:Up to approximately 24 months per subject (approximately 12 months for median)
Safety Issue:
Description:Defined as the time from the date of first dose of study treatment until the earliest date of disease progression or death from any cause.
Measure:Overall survival with parsaclisib
Time Frame:Up to approximately 36 months per subject
Safety Issue:
Description:Defined as the time from the date of first dose of study treatment until death from any cause.
Measure:Safety and tolerability of parsaclisib measured by adverse events (AEs)
Time Frame:Baseline through 30-35 days after end of treatment, up to approximately 12 months per subject
Safety Issue:
Description:Defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study treatment.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • Follicular lymphoma
  • non-Hodgkin lymphoma (NHL)
  • phosphatidylinositol 3-kinase (PI3K) δ inhibitor

Last Updated

September 11, 2019