topMIND: 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)

Incyte Corporation (Industry)
Overall Status
Recruiting ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Anticipated Enrollment :
100 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Masking Description:
Open Label
Primary Purpose:
Official Title:
A Phase 1b/2a Basket Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Combination Therapy With the Anti CD19 Monoclonal Antibody Tafasitamab and the PI3Kδ Inhibitor Parsaclisib in Adult Participants With Relapsed/Refractory Non Hodgkin Lymphoma or Chronic Lymphocytic Leukemia
Actual Study Start Date :
Sep 16, 2021
Anticipated Primary Completion Date :
Nov 6, 2023
Anticipated Study Completion Date :
Nov 6, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: tafasitamab + 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

Drug: tafasitamab
tafasitamab will be administered at a protocol defined dose once a week for cycles 1-3 and every other week from cycle 4 until progression.
Other Names:
  • INCMOR00208
  • Drug: parsaclisib
    parsaclisib will be administered at protocol defined dose for cycles 1 through disease progression.
    Other Names:
  • INCB050465
  • Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    1. 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.

    2. Pharmacokinetics Parameter : Cmax of tafasitamab [Up to 24 months]

      Maximum Observed Plasma Concentration of tafasitamab

    3. Pharmacokinetics Parameter : Cmin of tafasitamab [Up to 24 months]

      Minimum Observed Plasma Concentration of tafasitamab

    4. Pharmacokinetics Parameter : Tmax of tafasitamab [Up to 24 months]

      Time to reach maximum plasma concentration of tafasitamab

    5. Pharmacokinetics Parameter : AUC(t) of tafasitamab [Up to 24 months]

      Area under the concentration-time curve from time zero to time of tafasitamab

    6. Pharmacokinetics Parameter : Ctrough of tafasitamab [Up to 24 months]

      C trough concentration of tafasitamab

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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

    Contacts and Locations


    Site City State Country Postal Code
    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
    5 Norton Cancer Institute Louisville Kentucky United States 40202
    6 Cancer Center For Blood Disorders Bethesda Maryland United States 20817
    7 University of Michigan Ann Arbor Michigan United States 48109
    8 Clinical Research Alliance New Hyde Park New York United States 11042
    9 Ohio State University Columbus Ohio United States 43210
    10 Jefferson University Hospitals Philadelphia Pennsylvania United States 19107
    11 Ordensklinikum Linz Gmbh Elisabethinen Linz Austria A-4020
    12 Landeskrankenhaus Salzburg Salzburg Austria 05020
    13 Hanusch-Krankenhaus Der Wiener Gebietskrankenkasse Vienna Austria 01140
    14 Institut Jules Bordet Brussels Belgium B-1070
    15 Grand Hospital de Charleroi Charleroi Belgium 06000
    16 Universitair Ziekenhuis Antwerpen (Uza) Edegem Belgium 02650
    17 Az Groeninge Campus Kennedylaan Kortrijk Belgium 08500
    18 Universitair Ziekenhuis (Uz) Leuven Leuven Belgium 03000
    19 AZ DELTA Roeselare Belgium 08800
    20 University Hospital Brest Brest France 29609
    21 Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu Nantes France 44093
    22 Centre Henri Becquerel Rouen France 76038
    23 Institut Gustave Roussy Villejuif France 94805
    24 University Medical Center Freiburg Freiburg Germany 79106
    25 Justus-Liebig University Giessen Germany 35392
    26 Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii Mainz Germany 55131
    27 University Hospital Wurzburg Wurzburg Germany 97080
    28 S Orsolas University Hospital Seragnoli Institute of Hematology Bologna Italy 40138
    29 Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Meldola Italy 47014
    30 Fondazione Irccs Istituto Nazionale Dei Tumori Milan Italy 20133
    31 Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda Milan Italy 20162
    32 Istituto Nazionale Tumori Irccs Fondazione Pascale Naples Italy 80131
    33 Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello Palermo Italy 90146
    34 Azienda Ospedaliero Universitaria Pisana Pisa Italy 56126
    35 Ospedale Santa Maria Delle Croci Ravenna Italy 48121
    36 Irccs Istituto Clinico Humanitas Rozzano Italy 20089
    37 Hospital General Unviersitario de Alicante Alicante Spain 03010
    38 Hospital General Universitario Vall D Hebron Barcelona Spain 08035
    39 Hopital Sant Pau Barcelona Spain 08036
    40 Ico Institut Catala D Oncologia Barcelona Spain 08908
    41 Hospital Universitario San Cecilio Granada Spain 18016
    42 Hospital Universitario 12 de Octubre Madrid Spain 28041
    43 Centro Integral Oncologico Clara Campal (Ciocc) Madrid Spain 28050
    44 Hospital Universitario Quironsalud Madrid Madrid Spain 28223
    45 Hospital Puerta de Hierro Majadahonda Spain 28222
    46 Hospital Universitario Central de Asturias Oviedo Spain 33011
    47 Hospital Clinico Universitario de Salamanca Salamanca Spain 37007
    48 Hospital Universitario Marques de Valdecilla Santander Spain 39008
    49 Hospital Universitario Virgen Del Rocio Sevilla Spain 41015
    50 Hospital General Universitario de Valencia Valencia Spain 46014

    Sponsors and Collaborators

    • Incyte Corporation


    • Study Director: Oliver Manzke, MD, Incyte Corporation

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Incyte Corporation Identifier:
    Other Study ID Numbers:
    • INCMOR 0208-101
    First Posted:
    Mar 22, 2021
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Keywords provided by Incyte Corporation
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 27, 2022