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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1- Parsaclisib
Participants who have previously received ibrutinib.
  • Drug: Parsaclisib
    Parsaclisib at the protocol-defined dose.
    Other names:
    • INCB050465
Experimental
Cohort 2 - Parsaclisib
Participants who have not previously received a BTK inhibitor.
  • Drug: Parsaclisib
    Parsaclisib at the protocol-defined dose.
    Other names:
    • INCB050465

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Study Coordinator
205-996-8400

More Details

NCT ID
NCT03235544
Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

Incyte Corporation Call Center (US)
1.855.463.3463
medinfo@incyte.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.