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Chronic Lymphocytic LeukemiaPhase 1/2topMINDNCT04809467

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)

A Phase 1/2 study testing tafasitamab and parsaclisib in people with Chronic Lymphocytic Leukemia and Non Hodgkin Lymphoma, run by Incyte Corporation at 50 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
tafasitamab and parsaclisib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
50 sitesin 7 countries
Study dates
16 Sep 2021to 22 Oct 2024
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

50 sites in 7 countries.

50 sites in 7 countries

Spain14 sites

  • Hospital General Unviersitario de Alicante

    Alicante, 03010

  • Hospital General Universitario Vall D Hebron

    Barcelona, 08035

  • Hopital Sant Pau

    Barcelona, 08036

  • Ico Institut Catala D Oncologia

    Barcelona, 08908

  • Hospital Universitario San Cecilio

    Granada, 18016

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Centro Integral Oncologico Clara Campal (Ciocc)

    Madrid, 28050

  • Hospital Universitario Quironsalud Madrid

    Madrid, 28223

  • Hospital Puerta de Hierro

    Majadahonda, 28222

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Hospital Universitario Virgen Del Rocio

    Seville, 41015

  • Hospital General Universitario de Valencia

    Valencia, 46014

Other trials in Spain

United States10 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Cancer Center For Blood Disorders

    Bethesda, Maryland, 20817

  • University of Alabama At Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35205

  • Ohio State University

    Columbus, Ohio, 43210

  • Indiana Blood and Marrow Transplantation

    Indianapolis, Indiana, 46237

  • Community Health Network, Inc.

    Indianapolis, Indiana, 46250

  • University of Southern California

    Los Angeles, California, 90089

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • Clinical Research Alliance

    New Hyde Park, New York, 11042

  • Jefferson University Hospitals

    Philadelphia, Pennsylvania, 19107

Other trials in United States

Italy9 sites

  • S Orsolas University Hospital Seragnoli Institute of Hematology

    Bologna, 40138

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori

    Meldola, 47014

  • Fondazione Irccs Istituto Nazionale Dei Tumori

    Milan, 20133

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Istituto Nazionale Tumori Irccs Fondazione Pascale

    Naples, 80131

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

    Palermo, 90146

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

  • Ospedale Santa Maria Delle Croci

    Ravenna, 48121

  • Irccs Istituto Clinico Humanitas

    Rozzano, 20089

Other trials in Italy

Belgium6 sites

  • Institut Jules Bordet

    Brussels, B-1070

  • Grand Hospital de Charleroi

    Charleroi, 06000

  • Universitair Ziekenhuis Antwerpen (Uza)

    Edegem, 02650

  • Az Groeninge Campus Kennedylaan

    Kortrijk, 08500

  • Universitair Ziekenhuis (Uz) Leuven

    Leuven, 03000

  • AZ DELTA

    Roeselare, 08800

Other trials in Belgium

France4 sites

  • University Hospital Brest

    Brest, 29609

  • Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

    Nantes, 44093

  • Centre Henri Becquerel

    Rouen, 76038

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Germany4 sites

  • University Medical Center Freiburg

    Freiburg im Breisgau, 79106

  • Justus-Liebig University

    Giessen, 35392

  • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

    Mainz, 55131

  • University Hospital Wurzburg

    Würzburg, 97080

Other trials in Germany

Austria3 sites

  • Ordensklinikum Linz Gmbh Elisabethinen

    Linz, A-4020

  • Landeskrankenhaus Salzburg

    Salzburg, 05020

  • Hanusch-Krankenhaus Der Wiener Gebietskrankenkasse

    Vienna, 01140

Other trials in Austria

About this study

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

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.

Being tested
tafasitamab, parsaclisib
Keywords
Relapsed or Refractory, Leukemia, tafasitamab, parsaclisib, MOR00208, INCMOR00208
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin, Recurrence, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tafasitamabDrug

    Also called INCMOR00208

    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.

  • parsaclisibDrug

    Also called INCB050465

    parsaclisib will be administered at protocol defined dose for cycles 1 through disease progression.

Study groups in NCT04809467
Study groupRoleWhat they receive
tafasitamab + parsaclisibExperimentalParticipants 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
Receives: Drug: tafasitamab; Drug: parsaclisib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Any Treatment-emergent Adverse Event (TEAE )

    An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 90 days after the last dose of study drug.

    Measured: up to 1092 days

  2. Number of Participants With Any ≥Grade 3 TEAE

    An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 90 days after the last dose of study drug. The severity of AEs was assessed using CTCAE v5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.

    Measured: up to 1092 days

  3. Number of Participants With Dose-limiting Toxicities (DLTs)

    A DLT was defined as the occurrence of any protocol-defined toxicity up to and including Day 28 (Cycle 1/Day 28), except those with a clear alternative explanation.

    Measured: up to 28 days

  4. Objective Response Rate Based on Investigator Assessment: Percentage of Participants With CR/CMR or PR/PMR According to Lugano Criteria for NHL and International Working Group for Chronic Lymphocytic Leukemia (iwCLL) Criteria for CLL

    Lugano complete response/complete metabolic response (CR/CMR): target nodes/masses of lymph nodes/extralymphatic sites (LNs/ELSs) regressed to ≤1.5 cm; no non-measured lesions; organ enlargement regressed to normal; no new lesions (NNLs); normal bone marrow. Lugano partial response/partial metabolic response (PR/PMR): LNs/ELSs, ≥50% decrease in the product of perpendicular diameters sum for multiple lesions; no/regressed non-measured lesions, no increase; organ enlargement; NNLs. iwCLL CR: no LNs ≥1.5 cm; spleen size <13 cm/liver size normal; no constitutional symptoms; normal circulating lymphocyte count (CLC); ≥100 × 10^9 platelets/L; hemoglobin ≥11 g/dL; normocellular, no CLL cells, no B-lymphoid nodules in marrow. iwCLL PR decrease of ≥50% in lymph nodes, liver and/or spleen, and CLC from baseline; constitutional symptoms; ≥100 × 10^9 platelets/L or increase of ≥50% over baseline in platelet count and hemoglobin; presence of CLL cells, or of B-lymphoid nodules, or not done.

    Measured: up to 1002 days

Secondary outcomes (8)

  1. Cmax of Tafasitamab When Given in Combination With Parsaclisib

    Cmax was defined as the maximum observed plasma or serum concentration of tafasitamab.

    Measured: Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion

  2. Tmax of Tafasitamab When Given in Combination With Parsaclisib

    tmax was defined as the time to the maximum concentration of tafasitamab.

    Measured: Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion

  3. AUClast of Tafasitamab When Given in Combination With Parsaclisib

    AUClast was defined as the area under the plasma concentration-time curve from time zero to the time of the last measurable concentration.

    Measured: Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion

  4. AUC0-inf of Tafasitamab When Given in Combination With Parsaclisib

    AUC0-inf was defined as the area under the plasma concentration-time curve from time zero to infinity (time that the drug is no longer present in the body).

    Measured: Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion

  5. Clast of Tafasitamab When Given in Combination With Parsaclisib

    AUC0-inf was defined as the last measurable plasma drug concentration.

    Measured: Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion

  6. t1/2 of Tafasitamab When Given in Combination With Parsaclisib

    t1/2 was defined as the drug's elimination half-life, which is the time it takes for the concentration of a drug in the body to decrease by 50%.

    Measured: Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion

  7. CL of Tafasitamab When Given in Combination With Parsaclisib

    CL was defined as the apparent total body clearance of drug from plasma.

    Measured: Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion

  8. VZ of Tafasitamab When Given in Combination With Parsaclisib

    Vz was defined as the volume of distribution.

    Measured: Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2021
  2. Study start16 Sep 2021
  3. Primary completion22 Oct 2024
  4. Study completion22 Oct 2024

Why it stopped: A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04809467
Sponsor's protocol ID
INCMOR 0208-101
Other IDs
2020-005591-35
Acronym
topMIND
Status last verified
Feb 2026
First submitted
19 Mar 2021
Last updated
4 Feb 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing tafasitamab and parsaclisib in people with Chronic Lymphocytic Leukemia and Non Hodgkin Lymphoma, run by Incyte Corporation at 50 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in Spain, United States, Italy, Belgium, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) (time frame: up to 1092 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04809467.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.

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