Non Hodgkin Lymphoma Clinical Trial
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)
Summary
The purpose of this single-arm, open-label, Phase 1b/2a, multicenter basket study is to evaluate whether tafasitamab and parsaclisib can be safely combined at the recommended Phase 2 dose (RP2D) and dosing regimen that was established for each of the 2 compounds as a treatment option for adult participants with R/R B-cell malignancies.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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There are 50 Locations for this study
Birmingham Alabama, 35205, United States
Los Angeles California, 90089, United States
Indianapolis Indiana, 46237, United States
Indianapolis Indiana, 46250, United States
Louisville Kentucky, 40202, United States
Bethesda Maryland, 20817, United States
Ann Arbor Michigan, 48109, United States
New Hyde Park New York, 11042, United States
Columbus Ohio, 43210, United States
Philadelphia Pennsylvania, 19107, United States
Linz , A-402, Austria
Salzburg , 05020, Austria
Vienna , 01140, Austria
Brussels , B-107, Belgium
Charleroi , 06000, Belgium
Edegem , 02650, Belgium
Kortrijk , 08500, Belgium
Leuven , 03000, Belgium
Roeselare , 08800, Belgium
Brest , 29609, France
Nantes , 44093, France
Rouen , 76038, France
Villejuif , 94805, France
Freiburg , 79106, Germany
Giessen , 35392, Germany
Mainz , 55131, Germany
Wurzburg , 97080, Germany
Bologna , 40138, Italy
Meldola , 47014, Italy
Milan , 20133, Italy
Milan , 20162, Italy
Naples , 80131, Italy
Palermo , 90146, Italy
Pisa , 56126, Italy
Ravenna , 48121, Italy
Rozzano , 20089, Italy
Alicante , 03010, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 08908, Spain
Granada , 18016, Spain
Madrid , 28041, Spain
Madrid , 28050, Spain
Madrid , 28223, Spain
Majadahonda , 28222, Spain
Oviedo , 33011, Spain
Salamanca , 37007, Spain
Santander , 39008, Spain
Sevilla , 41015, Spain
Valencia , 46014, Spain
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