Back to resultsA 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) (topMIND)
Primary Purpose
Chronic Lymphocytic Leukemia, Non Hodgkin Lymphoma
Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
tafasitamab
parsaclisib
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring Relapsed or Refractory, Leukemia, tafasitamab, parsaclisib, MOR00208, INCMOR00208
Eligibility Criteria
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
Sites / Locations
- University of Alabama At Birmingham Comprehensive Cancer Center
- University of Southern California
- Indiana Blood and Marrow Transplantation
- Community Health Network, Inc.
- Norton Cancer Institute
- Cancer Center For Blood Disorders
- University of Michigan
- Clinical Research Alliance
- Ohio State University
- Jefferson University Hospitals
- Ordensklinikum Linz Gmbh Elisabethinen
- Landeskrankenhaus Salzburg
- Hanusch-Krankenhaus Der Wiener Gebietskrankenkasse
- Institut Jules Bordet
- Grand Hospital de Charleroi
- Universitair Ziekenhuis Antwerpen (Uza)
- Az Groeninge Campus Kennedylaan
- Universitair Ziekenhuis (Uz) Leuven
- AZ DELTA
- University Hospital Brest
- Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
- Centre Henri Becquerel
- Institut Gustave Roussy
- University Medical Center Freiburg
- Justus-Liebig University
- Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
- University Hospital Wurzburg
- S Orsolas University Hospital Seragnoli Institute of Hematology
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori
- Fondazione Irccs Istituto Nazionale Dei Tumori
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
- Istituto Nazionale Tumori Irccs Fondazione Pascale
- Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
- Azienda Ospedaliero Universitaria Pisana
- Ospedale Santa Maria Delle Croci
- Irccs Istituto Clinico Humanitas
- Hospital General Unviersitario de Alicante
- Hospital General Universitario Vall D Hebron
- Hopital Sant Pau
- Ico Institut Catala D Oncologia
- Hospital Universitario San Cecilio
- Hospital Universitario 12 de Octubre
- Centro Integral Oncologico Clara Campal (Ciocc)
- Hospital Universitario Quironsalud Madrid
- Hospital Puerta de Hierro
- Hospital Universitario Central de Asturias
- Hospital Clinico Universitario de Salamanca
- Hospital Universitario Marques de Valdecilla
- Hospital Universitario Virgen Del Rocio
- Hospital General Universitario de Valencia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
tafasitamab + parsaclisib
Arm Description
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
Outcomes
Primary Outcome Measures
Phase 1b : Number of Treatment Emergent Adverse Events
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
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
Phase 2a : Overall Response Rate
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
Maximum Observed Plasma Concentration of tafasitamab
Pharmacokinetics Parameter : Cmin of tafasitamab
Minimum Observed Plasma Concentration of tafasitamab
Pharmacokinetics Parameter : Tmax of tafasitamab
Time to reach maximum plasma concentration of tafasitamab
Pharmacokinetics Parameter : AUC(t) of tafasitamab
Area under the concentration-time curve from time zero to time of tafasitamab
Pharmacokinetics Parameter : Ctrough of tafasitamab
C trough concentration of tafasitamab
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04809467
Brief Title
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)
Acronym
topMIND
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 16, 2021 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Non Hodgkin Lymphoma
Keywords
Relapsed or Refractory, Leukemia, tafasitamab, parsaclisib, MOR00208, INCMOR00208
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
N/A
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tafasitamab + parsaclisib
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
tafasitamab
Other Intervention Name(s)
INCMOR00208
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
parsaclisib
Other Intervention Name(s)
INCB050465
Intervention Description
parsaclisib will be administered at protocol defined dose for cycles 1 through disease progression.
Primary Outcome Measure Information:
Title
Phase 1b : Number of Treatment Emergent Adverse Events
Description
Any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Time Frame
Up to 25 months
Title
Phase 1b : Incidence of Dose Limiting Toxicities
Description
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.
Time Frame
28 Days
Secondary Outcome Measure Information:
Title
Phase 2a : Overall Response Rate
Description
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.
Time Frame
Up to 25 months
Title
Pharmacokinetics Parameter : Cmax of tafasitamab
Description
Maximum Observed Plasma Concentration of tafasitamab
Time Frame
Up to 24 months
Title
Pharmacokinetics Parameter : Cmin of tafasitamab
Description
Minimum Observed Plasma Concentration of tafasitamab
Time Frame
Up to 24 months
Title
Pharmacokinetics Parameter : Tmax of tafasitamab
Description
Time to reach maximum plasma concentration of tafasitamab
Time Frame
Up to 24 months
Title
Pharmacokinetics Parameter : AUC(t) of tafasitamab
Description
Area under the concentration-time curve from time zero to time of tafasitamab
Time Frame
Up to 24 months
Title
Pharmacokinetics Parameter : Ctrough of tafasitamab
Description
C trough concentration of tafasitamab
Time Frame
Up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Manzke, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama At Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Facility Name
Indiana Blood and Marrow Transplantation
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Community Health Network, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Cancer Center For Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Clinical Research Alliance
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Jefferson University Hospitals
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Ordensklinikum Linz Gmbh Elisabethinen
City
Linz
ZIP/Postal Code
A-4020
Country
Austria
Facility Name
Landeskrankenhaus Salzburg
City
Salzburg
ZIP/Postal Code
05020
Country
Austria
Facility Name
Hanusch-Krankenhaus Der Wiener Gebietskrankenkasse
City
Vienna
ZIP/Postal Code
01140
Country
Austria
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
B-1070
Country
Belgium
Facility Name
Grand Hospital de Charleroi
City
Charleroi
ZIP/Postal Code
06000
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen (Uza)
City
Edegem
ZIP/Postal Code
02650
Country
Belgium
Facility Name
Az Groeninge Campus Kennedylaan
City
Kortrijk
ZIP/Postal Code
08500
Country
Belgium
Facility Name
Universitair Ziekenhuis (Uz) Leuven
City
Leuven
ZIP/Postal Code
03000
Country
Belgium
Facility Name
AZ DELTA
City
Roeselare
ZIP/Postal Code
08800
Country
Belgium
Facility Name
University Hospital Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
University Medical Center Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Justus-Liebig University
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
University Hospital Wurzburg
City
Wurzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
S Orsolas University Hospital Seragnoli Institute of Hematology
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Fondazione Irccs Istituto Nazionale Dei Tumori
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
City
Milan
ZIP/Postal Code
20162
Country
Italy
Facility Name
Istituto Nazionale Tumori Irccs Fondazione Pascale
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Ospedale Santa Maria Delle Croci
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
Irccs Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Hospital General Unviersitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital General Universitario Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hopital Sant Pau
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Ico Institut Catala D Oncologia
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Universitario San Cecilio
City
Granada
ZIP/Postal Code
18016
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Centro Integral Oncologico Clara Campal (Ciocc)
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitario Quironsalud Madrid
City
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hospital Puerta de Hierro
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Clinico Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41015
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency
Learn more about this trial
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)
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