Status:
WITHDRAWN
To Evaluate Efficacy and Safety of Parsaclisib Plus Either Rituximab or Obinutuzumab in R/R Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL) (CITADEL-302)
Lead Sponsor:
Incyte Corporation
Conditions:
Follicular Lymphoma ( FL)
Marginal Zone Lymphoma (MZL)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study of parsaclisib plus investigator's choice of either rituximab or obinutuzumab versus placebo plus investigator's choi...
Eligibility Criteria
Inclusion
- Male and female participants aged 18 years or older (Japan, aged 20 years or older).
- Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL
- Prior systemic treatment with at least 1 anti-CD20 mAb (either as monotherapy or in combination as chemoimmunotherapy)
- Documented disease that has relapsed or progressed or was refractory after the most recent prior systemic therapy. Note: Participants must not be refractory to anti-CD20 mAb
- Radiographically (CT, MRI) measurable lymphadenopathy per the Lugano criteria for response assessment (Cheson et al 2014).
- ECOG PS of 0 to 2
- Adequate organ functions including hematopoiesis, liver, and kidney
- Willingness to avoid pregnancy or fathering children
Exclusion
- Women who are pregnant or breastfeeding.
- Known histological transformation from indolent NHL to an aggressive NHL (eg, diffuse large B-cell lymphoma).
- Presence of CNS lymphoma (either primary or secondary) or leptomeningeal disease.
- Prior treatment with PI3K inhibitors.
- Inadequate washout of immunosuppressive therapy, anticancer medications and investigational drugs.
- Significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, GI, endocrine, pulmonary, neurological, cerebral, cardiac, infectious, or psychiatric disease.
- Known HIV infection.
- HBV or HCV infection: Participants positive for HBsAg or anti-HBc will be eligible if they are negative for HBV-DNA; these participants must receive prophylactic antiviral therapy. Participants positive for HCV antibody will be eligible if they are negative for HCV-RNA.
- History of other malignancy within 2 years of study entry.
- Any condition that would, in the investigator's judgment, interfere with full participation in the study.
Key Trial Info
Start Date :
December 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2032
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04796922
Start Date
December 30 2022
End Date
August 25 2032
Last Update
July 18 2022
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