Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND) (firmMIND)

March 13, 2024 updated by: Incyte Corporation

A Phase 3, Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

The purpose of this study is to assess the efficacy and safety of of tafasitamab plus lenalidomide in adults with diffuse large B-cell lymphoma (DLBCL) who have relapsed or are refractory to at least 1 but no more than 3 previous systemic DLBCL treatment regimens and who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

81

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Incyte Corporation Call Center (ex-US)
  • Phone Number: +800 00027423
  • Email: eumedinfo@incyte.com

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria, 04000
        • Recruiting
        • Medical University Plovdiv
      • Sofia, Bulgaria, 01431
        • Recruiting
        • UMHAT Sv. Ivan Rilski EAD
      • Sofia, Bulgaria, 01756
        • Recruiting
        • Specialized Hospital For Active Treatment of Oncological Diseases - Sofia District Eood
      • Sofia, Bulgaria, 01407
        • Recruiting
        • Acibadem Cityclinica Mhat Tokuda
      • Sofia, Bulgaria, 01431
        • Recruiting
        • Umhat Alexandrovska Sofia
  • Croatia
      • Zagreb, Croatia, 10000
        • Recruiting
        • University Hospital Centre Zagreb
      • Zagreb, Croatia, 10000
        • Recruiting
        • Clinical Hospital Dubrava
      • Zagreb, Croatia, 10000
        • Not yet recruiting
        • Clinical Hospital Merkur
  • Czechia
      • Olomouc, Czechia, 779 00
        • Recruiting
        • Fakultní nemocnice Olomouc
      • Prague 2, Czechia, 128 00
        • Recruiting
        • Všeobecná fakultní nemocnice
  • Denmark
      • Aarhus, Denmark, 08200
        • Recruiting
        • Aarhus University Hospital
      • Odense, Denmark, 05000
        • Recruiting
        • Odense University Hospital
  • Finland
      • Helsinki, Finland, FI-00029
        • Recruiting
        • Helsinki University Central Hospital
      • Kuopio, Finland, 70210
        • Recruiting
        • Kuopio University Hospital
      • Oulu, Finland, 90420
        • Recruiting
        • Oulu University Hospital
      • Tampere, Finland, 33520
        • Recruiting
        • Tampere University Hospital
      • Turku, Finland, 20520
        • Recruiting
        • Turku University Hospital
  • Hungary
      • Budapest, Hungary, 01088
        • Recruiting
        • Semmelweis Egyetem
      • Budapest, Hungary, 01122
        • Recruiting
        • National Institute of Oncology
      • Debrecen, Hungary, 04032
        • Recruiting
        • University of Debrecen
      • Eger, Hungary, 03300
        • Recruiting
        • Markhot Ferenc Korhaz
      • Kaposvar, Hungary, 07400
        • Recruiting
        • Somogy Medyei Kaposi Mor Oktato Korhaz
      • Szeged, Hungary, 06725
        • Recruiting
        • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
  • Ireland
      • Cork, Ireland, T12 DV56
        • Recruiting
        • Bon Secours Hospital
      • Dublin 7, Ireland, D07AX57
        • Recruiting
        • Mater Misericordiae University Hospital
      • Galway, Ireland, H91 YR71
        • Not yet recruiting
        • University Hospital Galway
  • Israel
      • Haifa, Israel, 31096
        • Recruiting
        • Rambam Health Care Campus
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek MC
      • Jerusalem, Israel, 92210
        • Recruiting
        • Hadassah University Hospital
      • Kefar Sava, Israel, 44281
        • Recruiting
        • Meir Medical Center
  • Norway
      • Lorenskog, Norway, 01478
        • Recruiting
        • Akershus University Hospital
      • Trondheim, Norway, 07006
        • Not yet recruiting
        • Universitetssykehuset I Trondheim - St. Olavs Hospital
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Recruiting
        • Szpital Uniwersytecki nr 2 im dr. Jana Biziela
      • Gdansk, Poland, 80-211
        • Recruiting
        • Medical University of Gdansk
      • Gdynia, Poland, 81-519
        • Recruiting
        • Szpital Morski Im. Pck Sp. Z O.O
      • Lublin, Poland, 20-081
        • Recruiting
        • University Public Hospital Nr 1
      • Olsztyn, Poland, 10-228
        • Completed
        • Oddzia Kliniczny Hematologii
      • Skórzewo, Poland, 60-185
        • Recruiting
        • Pratia Poznań
      • Warszawa, Poland, 02-0781
        • Recruiting
        • Maria Sklodowska-Curie National Research Institute of Oncology
      • Wroclaw, Poland, 50-367
        • Recruiting
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
  • Romania
      • Bucharest, Romania, 30167
        • Recruiting
        • Coltea Clinical Hospital
      • Cluj-napoca, Romania, 400015
        • Recruiting
        • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
      • Iasi, Romania, 700483
        • Recruiting
        • Institutul Regional de Oncologie Iasi
      • Targu Mures, Romania, 540136
        • Recruiting
        • Spitalul Clinic Judetean de Urgenta Targu Mures
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinic For Hematology, University Clinical Center Serbia
      • Kragujevac, Serbia, 34000
        • Recruiting
        • Clinical Center Kragujevac
      • Novi Sad, Serbia, 21000
        • Recruiting
        • Clinic of Hematology Clinical Center of Vojvodina
      • Sremska Kamenica, Serbia, 21204
        • Recruiting
        • Institute for pulmonary diseases of Vojvodina
  • Turkey
      • Ankara, Turkey, 06560
        • Recruiting
        • Gazi University Hospital Gazi University Faculty of Medicine
      • Ankara, Turkey, 06680
        • Recruiting
        • Ozel Liv Hospital Onkoloji Klinigi
      • Ankara, Turkey, 06629
        • Recruiting
        • Ankara University Medical Faculty
      • Ankara, Turkey, 06230
        • Recruiting
        • Hacettepe University Cancer Institute Clinical Oncology Department
      • Istanbul, Turkey, 34365
        • Recruiting
        • Vkf American Hospital
      • Istanbul, Turkey, 34899
        • Recruiting
        • Marmara Universitesi Pendik Egitim
      • Izmir, Turkey, 35040
        • Not yet recruiting
        • Ege University Hospital
      • Kayseri, Turkey, 38039
        • Not yet recruiting
        • Ercyes University Medical School
      • Merkez, Turkey, 59030
        • Recruiting
        • Tekrda-Nk Tp Fakltesi
      • Mersin, Turkey, 33000
        • Recruiting
        • Mersin University Medical Faculty
      • Yenimahalle, Turkey, 06200
        • Recruiting
        • Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospitalerciyes Universitesi Tip Faklutesi
  • United Kingdom
      • Antrim, United Kingdom, BT41 2RL
        • Not yet recruiting
        • Antrim Area Hospital Northern Health Social Care Trust
      • Belfast, United Kingdom, BT9 7AB
        • Not yet recruiting
        • Belfast Health and Social Care Trust, of Trust Headquarters

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically-confirmed diagnosis of any of the following:

    1. Diffuse large B-cell lymphoma not otherwise specified
    2. T cell/histiocyte-rich large B-cell lymphoma
    3. Epstein-Barr virus positive DLBCL of the elderly
    4. Grade 3b follicular lymphoma
    5. Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse
    6. Evidence of histological transformation from an earlier diagnosis of low grade lymphoma (ie, an indolent pathology such as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia) into DLBCL, with a subsequent DLBCL relapse
  • Willingness to undergo tumor biopsy requirements for the study, (or have archival lymph node or tissue block from the most recent biopsy, not to exceed 3 years prior to C1D1).
  • Willingness to undergo bone marrow biopsy/aspirate collections.
  • History of relapsed/progressive/recurrent disease according to the International Working Group response criteria after the most recent systemic therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Adequate hematologic, hepatic, and renal function,
  • Left ventricular ejection fraction (LVEF) ≥ 50%,
  • Willingness to avoid pregnancy or fathering children,

Exclusion Criteria:

  • Any other histological type of lymphoma according to the WHO 2016 classification of lymphoid neoplasms, including:

    1. primary mediastinal (thymic) large B-cell lymphoma,
    2. Burkitt lymphoma,
    3. Primary refractory diffuse large B-cell lymphoma (DLBCL),
    4. History of double- or triple-hit DLBCL.

  • Participants who, within 30 days prior to Cycle 1 Day 1, have:

    1. Not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma-specific therapy
    2. Undergone major surgery or suffered from significant traumatic injury
    3. Received live vaccines or have an anticipated need for such vaccination while receiving study treatment
    4. Required parenteral antimicrobial therapy for active, intercurrent infections
  • Have undergone ASCT within the period ≤ 3 months prior to signing consent.
  • Have undergone previous allogenic stem cell transplantation.
  • Inadequate recovery (> Grade 1) from prior treatment toxicity and/or complications from major surgery before Cycle 1 Day 1.
  • Have a history of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia or are at high risk for a thromboembolic event in the opinion of the investigator and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period.
  • Prior history of malignancies other than DLBCL, unless disease-free for ≥ 5 years prior to screening.
  • Clinically significant cardiac disease, including unstable angina, acute myocardial infarction, New York Heart Association Class II to IV congestive heart failure, uncontrolled arrhythmia, and/or cardiac conduction issues, within 6 months of Cycle 1 Day 1.

  • Any of the following positive tests:

    1. Known seropositive for or history of active viral infection with HIV.
    2. Known positive test result for hepatitis C (HCV antibody serology testing) and a positive test result for HCV RNA.
    3. Known positive test results for chronic HBV infection (defined by HBsAg positivity). Participants with occult or prior HBV infection (defined as negative HBsAg and positive total HBcAb) may be included if HBV DNA was undetectable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tafasitamab and Lenalidomide
Tafasitamab and lenalidomide will be coadministered for up to 12 cycles (28 days per cycle).followed by tafasitamab monotherapy (in participants with stable disease or better) until treatment withdrawal criteria are met.
Drug: Tafasitamab
Tafasitamab will be administered intravenously in 28-day cycles. During Cycles 1 through 3, tafasitamab will be administered weekly on Days 1, 8, 15, and 22; an additional loading dose will be administered on Cycle 1 Day 4. Starting with Cycle 4, tafasitamab will be administered on Days 1 and 15 of each cycle.
Other Names:
  • MOR00208
  • INCMOR00208
Drug: Lenalidomide
Participants will self-administer lenalidomide capsules orally on Days 1-21 of each 28-day cycle, up to 12 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: Approximately 24 months
Percentage of participants having best response of Complete Response (CR) or Partial Response (PR) as per Independent Review Committee and investigator's assessment.
Approximately 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR)
Time Frame: Approximately 24 months
Defined as the time from the first documented CR or PR until the date of first documented disease progression or death due to any cause, whichever occurs first, among participants who achieve CR or PR per Independent Review Committee (IRC) assessment and investigator's assessment.
Approximately 24 months
Progression Free Survial (PFS)
Time Frame: Approximately 24 months
Defined as the time from the date of first dose until the first documented disease progression, or death due to any cause, whichever occurs first per IRC assessment and investigator's assessment.
Approximately 24 months
Disease Control Rate (DCR)
Time Frame: Approximately 24 months
Defined as the percentage of participants who achieve CR, PR, or SD as per IRC assessment and investigator's assessment.
Approximately 24 months
Time to Next Treatment (TTNT)
Time Frame: Approximately 24 months
Defined as the time from first dose until the initiation of new anticancer therapy or death due to any reason, whichever occurs first.
Approximately 24 months
Overall Survival (OS)
Time Frame: Approximately 24 months
Defined as the time from the date of first dose until death due to any cause.
Approximately 24 months
Number of treatment-emergent adverse events
Time Frame: Approximately 24 months
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 90 days after last dose of study treatment.
Approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Investigators

  • Study Director: Oliver Manzke, MD, Incyte Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2022

Primary Completion (Estimated)

December 24, 2025

Study Completion (Estimated)

December 24, 2026

Study Registration Dates

First Submitted

June 17, 2022

First Submitted That Met QC Criteria

June 17, 2022

First Posted (Actual)

June 23, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCMOR 0208-305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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