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)
Stopped early · Phase 1/Phase 2
Conditions studied: Chronic Lymphocytic Leukemia, Non Hodgkin Lymphoma
In brief
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.
Key facts
- Study ID
- NCT04809467
- Run by
- Incyte Corporation
- People needed
- 54
- Starts
- 2021-09-16
- Expected to finish
- 2024-10-22
- Last updated by the study team
- 2026-02-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 qualify 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
Where it is running
- University of Alabama At Birmingham Comprehensive Cancer Center — Birmingham, Alabama, United States
- University of Southern California — Los Angeles, California, United States
- Indiana Blood and Marrow Transplantation — Indianapolis, Indiana, United States
- Community Health Network, Inc. — Indianapolis, Indiana, United States
- Norton Cancer Institute — Louisville, Kentucky, United States
- Cancer Center For Blood Disorders — Bethesda, Maryland, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Clinical Research Alliance — New Hyde Park, New York, United States
- Ohio State University — Columbus, Ohio, United States
- Jefferson University Hospitals — Philadelphia, Pennsylvania, United States
- Ordensklinikum Linz Gmbh Elisabethinen — Linz, Austria
- Landeskrankenhaus Salzburg — Salzburg, Austria
- Hanusch-Krankenhaus Der Wiener Gebietskrankenkasse — Vienna, Austria
- Institut Jules Bordet — Brussels, Belgium
- Grand Hospital de Charleroi — Charleroi, Belgium
- Universitair Ziekenhuis Antwerpen (Uza) — Edegem, Belgium
- Az Groeninge Campus Kennedylaan — Kortrijk, Belgium
- Universitair Ziekenhuis (Uz) Leuven — Leuven, Belgium
- AZ DELTA — Roeselare, Belgium
- University Hospital Brest — Brest, France
- Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu — Nantes, France
- Centre Henri Becquerel — Rouen, France
- Institut Gustave Roussy — Villejuif, France
- University Medical Center Freiburg — Freiburg im Breisgau, Germany
- Justus-Liebig University — Giessen, Germany
Full record on ClinicalTrials.gov
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