Clinical Trials /

Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)

NCT04434937

Description:

The purpose of this study is to assess the efficacy and safety of parsaclisib in Japanese participants with relapsed or refractory follicular lymphoma

Related Conditions:
  • Grade 1 Follicular Lymphoma
  • Grade 2 Follicular Lymphoma
  • Grade 3 Follicular Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)
  • Official Title: A Phase 2, Multicenter, Open-Label Study of Parsaclisib, a PI3Kδ Inhibitor, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)

Clinical Trial IDs

  • ORG STUDY ID: INCB 50465-213
  • NCT ID: NCT04434937

Conditions

  • Lymphoma

Interventions

DrugSynonymsArms
parsaclisibINCB050465parsaclisib

Purpose

The purpose of this study is to assess the efficacy and safety of parsaclisib in Japanese participants with relapsed or refractory follicular lymphoma

Trial Arms

NameTypeDescriptionInterventions
parsaclisibExperimentalparsaclisib will be taken orally QD with water without regard to food except on mornings of PK clinic visits
  • parsaclisib

Eligibility Criteria

        Inclusion Criteria:

          -  Male or female Japanese participant who must be ≥ 18 years of age

          -  Histologically confirmed, relapsed or refractory, FL Grade 1, 2, and 3a

          -  Ineligible for HSCT

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

          -  ECOG performance status 0 to 2

          -  Life expectancy ≥ 12 weeks

          -  Female participants agree to use medically acceptable contraceptive measures, should
             not be breastfeeding, and must have a negative pregnancy test before the start of
             study drug administration.

          -  Female participants of childbearing potential must understand and accept that
             pregnancy must be avoided during participation in the study.

          -  Male participants should avoid fathering children from screening through at least 90
             days after the last dose of study treatment.

        Exclusion Criteria:

          -  Known histological transformation from indolent NHL to DLBCL

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

          -  Prior treatment with the following:

               1. Selective PI3Kδ or pan-PI3K inhibitors (eg, idelalisib, copanlisib, duvelisib,
                  etc).

               2. Bruton's tyrosine kinase inhibitor (eg, ibrutinib).

          -  Allogeneic SCT within the last 6 months, or autologous SCT within the last 3 months
             before the date of study treatment administration

          -  Active graft-versus-host disease

          -  Use of immunosuppressive therapy within 28 days of the date of study treatment
             administration

          -  Concurrent anticancer therapy

          -  Significant concurrent, uncontrolled medical condition including, but not limited to,
             renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological,
             cerebral, or psychiatric disease

          -  Current or previous other malignancy within 3 years of study entry, except cured basal
             or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial
             neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy
             without sponsor approval.

          -  Hepatitis B (HBV) or HCV infection

          -  Current New York Heart Association Class II to IV congestive heart failure or
             uncontrolled arrhythmia
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:Up to approximately 2 years
Safety Issue:
Description:Defined as the percentage of participants with a CR or PR as defined by revised response criteria for lymphoma (Cheson et al 2014), as determined by an IRC

Secondary Outcome Measures

Measure:Complete response rate (CRR)
Time Frame:Up to approximately 2 years
Safety Issue:
Description:Defined as the percentage of participants with a CR as defined by revised response criteria for lymphomas (Cheson et al 2014), as determined by an IRC.
Measure:Duration of response (DOR)
Time Frame:Up to approximately 2 years
Safety Issue:
Description:Defined as the time from first documented evidence of CR or PR until disease progression or death from any cause among participants who achieve an objective response, as determined by radiographic disease assessment provided by an IRC.
Measure:Progression-free survival (PFS)
Time Frame:Up to approximately 2 years
Safety Issue:
Description:Defined as the time from the date of the first dose of study treatment until the earliest date of disease progression, as determined by radiographic disease assessment provided by an IRC, or death from any cause.
Measure:Overall survival
Time Frame:Up to approximately 2 years
Safety Issue:
Description:Defined as the time from the date of the first dose of study treatment until death from any cause
Measure:Best percentage change in target lesion size
Time Frame:Up to approximately 2 years
Safety Issue:
Description:Best percentage change in target lesion size from baseline, where target lesion size is measured by the sum of the product of the diameters of all target lesion sizes.
Measure:Number of participants with treatment-emergent adverse events (TEAEs)
Time Frame:Up to approximately 2 years
Safety Issue:
Description:TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Biosciences Japan GK

Trial Keywords

  • Follicular Lymphoma
  • Parsaclisib
  • PI3Kδ Inhibitor

Last Updated

October 6, 2020