Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
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.
Phase
Phase 2
Funding Agency/Sponsor
Industrial
Disease
Lymphoma
Enrollment Eligibility
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.