Clareo Health | 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)
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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Incyte Corporation
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
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.
You may not be if
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.
