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 Southern California
🇺🇸Los Angeles, California, United States
Indiana Blood and Marrow Transplantation
🇺🇸Indianapolis, Indiana, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Institut Jules Bordet
🇧🇪Brussels, Belgium
Jefferson University Hospitals
🇺🇸Philadelphia, Pennsylvania, United States
Ordensklinikum Linz Gmbh Elisabethinen
🇦🇹Linz, Austria
Clinical Research Alliance
🇺🇸New Hyde Park, New York, United States
Hanusch-Krankenhaus Der Wiener Gebietskrankenkasse
🇦🇹Vienna, Austria
Community Health Network, Inc.
🇺🇸Indianapolis, Indiana, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
Landeskrankenhaus Salzburg
🇦🇹Salzburg, Austria
S Orsolas University Hospital Seragnoli Institute of Hematology
🇮🇹Bologna, Italy
Istituto Nazionale Tumori Irccs Fondazione Pascale
🇮🇹Naples, Italy
Institut Gustave Roussy
🇫🇷Villejuif, France
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
🇫🇷Nantes, France
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
🇮🇹Palermo, Italy
Hospital General Universitario Vall D Hebron
🇪🇸Barcelona, Spain
Hopital Sant Pau
🇪🇸Barcelona, Spain
University Medical Center Freiburg
🇩🇪Freiburg, Germany
Centre Henri Becquerel
🇫🇷Rouen, France
Centro Integral Oncologico Clara Campal (Ciocc)
🇪🇸Madrid, Spain
Hospital Universitario Quironsalud Madrid
🇪🇸Madrid, Spain
Az Groeninge Campus Kennedylaan
🇧🇪Kortrijk, Belgium
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
🇮🇹Milan, Italy
Hospital Puerta de Hierro
🇪🇸Majadahonda, Spain
Ico Institut Catala D Oncologia
🇪🇸Barcelona, Spain
Hospital Universitario San Cecilio
🇪🇸Granada, Spain
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori
🇮🇹Meldola, Italy
Hospital Clinico Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Hospital General Unviersitario de Alicante
🇪🇸Alicante, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Grand Hospital de Charleroi
🇧🇪Charleroi, Belgium
Universitair Ziekenhuis Antwerpen (Uza)
🇧🇪Edegem, Belgium
University of Alabama At Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Fondazione Irccs Istituto Nazionale Dei Tumori
🇮🇹Milan, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
Ospedale Santa Maria Delle Croci
🇮🇹Ravenna, Italy
Irccs Istituto Clinico Humanitas
🇮🇹Rozzano, Italy
Hospital Universitario Marques de Valdecilla
🇪🇸Santander, Spain
Justus-Liebig University
🇩🇪Giessen, Germany
University Hospital Wurzburg
🇩🇪Wurzburg, Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
🇩🇪Mainz, Germany
Cancer Center For Blood Disorders
🇺🇸Bethesda, Maryland, United States
AZ DELTA
🇧🇪Roeselare, Belgium
University Hospital Brest
🇫🇷Brest, France
Hospital Universitario Virgen Del Rocio
🇪🇸Sevilla, Spain
Universitair Ziekenhuis (Uz) Leuven
🇧🇪Leuven, Belgium