Clinical trial NCT05429268: Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND)
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma
Keywords: MOR00208
INCMOR00208
tafasitamab
lenalidomide
firmMIND
Diffuse Large B-Cell Lymphoma
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2022-06-23
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm, open-label, multicenter
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Approximately 24 months
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: Approximately 24 months
measure: Progression Free Survial (PFS)
timeFrame: Approximately 24 months
measure: Disease Control Rate (DCR)
timeFrame: Approximately 24 months
measure: Time to Next Treatment (TTNT)
timeFrame: Approximately 24 months
measure: Overall Survival (OS)
timeFrame: Approximately 24 months
measure: Number of treatment-emergent adverse events
timeFrame: Approximately 24 months
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: Medical University Plovdiv
city: Sofia
country: Bulgaria
facility: Acibadem Cityclinica Mhat Tokuda
city: Sofia
country: Bulgaria
facility: Umhat Alexandrovska Sofia
city: Sofia
country: Bulgaria
facility: Umhat Sv. Ivan Rilski Ead
city: Sofia
country: Bulgaria
facility: Specialized Hospital For Active Treatment of Oncological Diseases - Sofia District Eood
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava
city: Zagreb
country: Croatia
facility: Clinical Hospital Merkur
city: Zagreb
country: Croatia
facility: University Hospital Centre Zagreb
city: Olomouc
country: Czechia
facility: Fakultni Nemocnice Olomouc
city: Prague 2
country: Czechia
facility: Vseobecna Fakultni Nemocnice
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: National Institute of Oncology
city: Debrecen
country: Hungary
facility: University of Debrecen
city: Eger
country: Hungary
facility: Markhot Ferenc Korhaz
city: Kaposvar
country: Hungary
facility: Somogy Medyei Kaposi Mor Oktato Korhaz
city: Szeged
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
city: Cork
country: Ireland
facility: Bon Secours Hospital
city: Dublin 7
country: Ireland
facility: Mater Misericordiae University Hospital
city: Galway
country: Ireland
facility: University Hospital Galway
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Shaare Zedek Mc
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
city: Kefar Sava
country: Israel
facility: Meir Medical Center
city: Lorenskog
country: Norway
facility: Akershus University Hospital
city: Trondheim
country: Norway
facility: Universitetssykehuset I Trondheim - St. Olavs Hospital
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr 2 Im Dr. Jana Biziela
city: Gdansk
country: Poland
facility: Medical University of Gdansk
city: Gdynia
country: Poland
facility: Szpital Morski Im. Pck Sp. Z O.O
city: Lublin
country: Poland
facility: University Public Hospital Nr 1
city: Olsztyn
country: Poland
facility: Oddzia Kliniczny Hematologii
city: Skórzewo
country: Poland
facility: Pratia Poznan
city: Warszawa
country: Poland
facility: Maria Sklodowska-Curie National Research Institute of Oncology
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego
city: Bucharest
country: Romania
facility: Coltea Clinical Hospital
city: Cluj-napoca
country: Romania
facility: Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iasi
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Targu Mures
city: Belgrade
country: Serbia
facility: Clinic For Hematology, University Clinical Center Serbia
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Novi Sad
country: Serbia
facility: Clinic of Hematology Clinical Center of Vojvodina
city: Sremska Kamenica
country: Serbia
facility: Institute For Pulmonary Diseases of Vojvodina
city: Ankara
country: Turkey
facility: Hacettepe University Cancer Institute Clinical Oncology Department
city: Ankara
country: Turkey
facility: Gazi University Hospital Gazi University Faculty of Medicine
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Ankara
country: Turkey
facility: Ozel Liv Hospital Onkoloji Klinigi
city: Istanbul
country: Turkey
facility: Vkf American Hospital
city: Istanbul
country: Turkey
facility: Marmara Universitesi Pendik Egitim
city: Izmir
country: Turkey
facility: Ege University Hospital
city: Kayseri
country: Turkey
facility: Ercyes University Medical School
city: Merkez
country: Turkey
facility: Tekrda-Nk Tp Fakltesi
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
city: Yenimahalle
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospitalerciyes Universitesi Tip Faklutesi
city: Antrim
country: United Kingdom
facility: Antrim Area Hospital Northern Health Social Care Trust
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust, of Trust Headquarters
Study officials:
affiliation: Incyte Corporation
name: Oliver Manzke, MD
role: STUDY_DIRECTOR
References: