Status:
COMPLETED
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)
Lead Sponsor:
Incyte Corporation
Conditions:
Chronic Lymphocytic Leukemia
Non Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2024
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04809467
Start Date
September 16 2021
End Date
October 22 2024
Last Update
August 3 2025
Active Locations (50)
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1
University of Alabama At Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35205
2
University of Southern California
Los Angeles, California, United States, 90089
3
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, United States, 46237
4
Community Health Network, Inc.
Indianapolis, Indiana, United States, 46250