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Purpose

The purpose of this study is to evaluate the safety and efficacy of two parsaclisib treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL) who are naive to or were previously treated with 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 or older (except in South Korea, aged 19 or older). - Histologically confirmed marginal zone lymphoma, including extranodal, nodal, and splenic subtypes. - Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest transverse diameter and ≥ 1.0 cm in the longest perpendicular diameter. - Participants with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed. - Participants must be willing to undergo an incisional or excisional lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue. - Eastern Cooperative Oncology Group performance status 0 to 2.

Exclusion Criteria

  • Evidence of diffuse large B-cell transformation. - History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease. - 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 the first dose of study treatment. - 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.

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- Closed to Further enrollment 		Participants who have received prior ibrutinib.
  • Drug: Parsaclisib
    Parsaclisib at the protocol-defined dose.
    Other names:
    • INCB050465
Experimental
Cohort 2 		Participants who have not received a prior BTK inhibitor.
  • Drug: Parsaclisib
    Parsaclisib at the protocol-defined dose.
    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.