A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL)
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
Histologically confirmed R/R B-cell malignancy: DLBCL (THRLBCL, EBV-positive DLBCL of the elderly, Grade 3b FL, HGBL with MYC and BCL2 and/or BCL6 rearrangements, transformed lymphoma); MCL ((with cyclin D1 overexpression or t(11;14); FL (Grade 1, 2, 3a); MZL (extranodal, nodal, splenic) ; CLL, or SLL
Willingness to undergo biopsy
At least 2 prior systemic treatment regimens, including prior treatment with an anti-CD20 antibody (all cohorts) or prior treatment with a BTK inhibitor (CLL/SLL)
Relapsed, progressive, or refractory NHL or CLL
For NHL/SLL: Radiographically measurable nodal or extranodal disease (all cohorts except CLL)
ECOG-PS 0 - 2
LVEF ≥ 50%
Adequate renal, hepatic, bone marrow function
You may not be if
Any other histological type of lymphoma
Primary or secondary CNS lymphoma
Anticancer and/or investigational therapy within the past 30 days or 5 half-lives
Allogeneic stem cell transplantation within the past 6 months, or ASCT within 3 months before C1D1
Previous treatment with CD19-targeted therapy or PI3K inhibitors
Clinically significant cardiac disease
Other malignancy within the past 3 years
Active graft-versus-host disease
Stroke or intracranial hemorrhage within the past 6 months
Chronic or current active infectious disease
Positive virus serology for HCV, HBV, HIV
Currently pregnant or breastfeeding
Clareo Health | A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL)
