Clinical Trials /

A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)

NCT03235544

Description:

This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in subjects with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.

Related Conditions:
  • Mantle Cell Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)
  • Official Title: A Phase 2, Open-Label, 2-Cohort, Multicenter Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)

Clinical Trial IDs

  • ORG STUDY ID: INCB 50465-205 (CITADEL-205)
  • SECONDARY ID: Parsaclisib
  • NCT ID: NCT03235544

Conditions

  • Lymphoma

Interventions

DrugSynonymsArms
ParsaclisibINCB050465Cohort 1- Parsaclisib

Purpose

This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in subjects with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.

Trial Arms

NameTypeDescriptionInterventions
Cohort 1- ParsaclisibExperimentalParticipants who have previously received ibrutinib.
  • Parsaclisib
Cohort 2 - ParsaclisibExperimentalParticipants who have not previously received a BTK inhibitor.
  • Parsaclisib

Eligibility Criteria

        Inclusion Criteria:

          -  Men and women, aged 18 years or older.

          -  Documented failure to achieve at least PR with, or documented disease progression
             after, the most recent treatment regimen.

          -  Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

        Exclusion Criteria:

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

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

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

          -  Active graft-versus-host disease.

          -  Liver 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
Time Frame:Protocol-defined timepoints throughout the treatment period, up to approximately 16 months per participant.
Safety Issue:
Description:Defined as the percentage of participants with a complete response (CR) or partial response (PR) as determined by computed tomography (CT)-based response criteria for lymphomas.

Secondary Outcome Measures

Measure:Duration of response
Time Frame:Protocol-defined timepoints throughout the treatment period, up to approximately 16 months per participant.
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:Complete response rate
Time Frame:Protocol-defined timepoints throughout the treatment period, up to approximately 16 months per participant.
Safety Issue:
Description:Defined as the percentage of participants with a CR as defined by response criteria for lymphomas.
Measure:Progression-free survival
Time Frame:Protocol-defined timepoints throughout the treatment period, up to approximately 16 months per participant.
Safety Issue:
Description:Defined as the time from the date of the first dose of study treatment until the earliest date of disease progression or death from any cause.
Measure:Overall survival
Time Frame:Protocol-defined timepoints throughout the treatment period, up to approximately 26 months.
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 from baseline
Time Frame:Protocol-defined timepoints throughout the treatment period, up to approximately 16 months per participant.
Safety Issue:
Description:Target lesion size measured by the sum of the product of diameters of all target lesion sizes.
Measure:Safety and tolerability of parsaclisib as measured by adverse events (AEs)
Time Frame:Up to approximately 16 months per participant.
Safety Issue:
Description:An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent.

Details

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

Trial Keywords

  • Mantle cell lymphoma
  • non-Hodgkin lymphoma
  • Bruton's tyrosine kinase (BTK)
  • phosphatidylinositol 3-kinase (PI3K)

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