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Purpose

This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in participants 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 partial response (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 phosphatidylinositol 3-kinase delta (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: Participants positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for hepatitis B virus-deoxyribonucleic acid (HBV-DNA). Participants positive for anti-hepatitis C virus (HCV) antibody will be eligible if they are negative for HCV-ribonucleic acid (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: Treatment A (Exposed to Ibrutinib) 		Participants received parsaclisib 20 mg tablets, orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
  • Drug: Parsaclisib
    Parsaclisib tablets administered orally with water and without regard to food.
    Other names:
    • INCB050465
Experimental
Cohort 1: Treatment B (Exposed to Ibrutinib) 		Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
  • Drug: Parsaclisib
    Parsaclisib tablets administered orally with water and without regard to food.
    Other names:
    • INCB050465
Experimental
Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) 		Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who had not received a BTK inhibitor previously were included in this group.
  • Drug: Parsaclisib
    Parsaclisib tablets administered orally with water and without regard to food.
    Other names:
    • INCB050465
Experimental
Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) 		Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who had not received a BTK inhibitor previously were included in this group.
  • Drug: Parsaclisib
    Parsaclisib tablets administered orally with water and without regard to food.
    Other names:
    • INCB050465

More Details

Status
Active, not recruiting
Sponsor
Incyte Corporation

Study Contact

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.