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)
- Conditions
- Chronic Lymphocytic LeukemiaNon Hodgkin Lymphoma
- Interventions
- Registration Number
- NCT04809467
- Lead Sponsor
- Incyte Corporation
- 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 dosing regimen that was established for each of the 2 compounds as a treatment option for adult participants with R/R B-cell malignancies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description tafasitamab + parsaclisib tafasitamab Participants will be assigned to disease specific cohorts based on the histology of their underlying disease. Cohort 1: R/R DLBCL Cohort 2: R/R MCL Cohort 3: R/R FL Cohort 4: R/R MZL Cohort 5: R/R CLL/SLL tafasitamab + parsaclisib parsaclisib Participants will be assigned to disease specific cohorts based on the histology of their underlying disease. Cohort 1: R/R DLBCL Cohort 2: R/R MCL Cohort 3: R/R FL Cohort 4: R/R MZL Cohort 5: R/R CLL/SLL
- Primary Outcome Measures
Name Time Method Phase 1b : Number of Treatment Emergent Adverse Events Up to 25 months Any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Phase 1b : Incidence of Dose Limiting Toxicities 28 Days Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol. All DLTs will be assessed for severity by the investigator using CTCAE v5.0 criteria.
- Secondary Outcome Measures
Name Time Method Phase 2a : Overall Response Rate Up to 25 months Defined as the percentage of participants experiencing a best response of Complete Response/Complete Metabolic Response (CR/CMR) or Partial Response/Partial Metabolic Response (PR/PMR) according to the Lugano criteria (Cheson et al 2014) for NHL and the iwCLL criteria (Hallek et al 2018) for CLL.
Pharmacokinetics Parameter : Cmax of tafasitamab Up to 24 months Maximum Observed Plasma Concentration of tafasitamab
Pharmacokinetics Parameter : Cmin of tafasitamab Up to 24 months Minimum Observed Plasma Concentration of tafasitamab
Pharmacokinetics Parameter : Tmax of tafasitamab Up to 24 months Time to reach maximum plasma concentration of tafasitamab
Pharmacokinetics Parameter : AUC(t) of tafasitamab Up to 24 months Area under the concentration-time curve from time zero to time of tafasitamab
Pharmacokinetics Parameter : Ctrough of tafasitamab Up to 24 months C trough concentration of tafasitamab
Trial Locations
- Locations (50)
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
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