Lymphoma

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

Incyte Study ID:
INCMOR 0208-305
CT.gov ID:
NCT05429268
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruitment Complete
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Clinical Study Purpose

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).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Lymphoma
    • PRODUCT
  • Drug: Tafasitamab
  • Drug: Lenalidomide
    • COLLABORATORS
    N/A
    DATE
    Dec 2022 - Apr 2026
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    18 - 99 Years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Histologically-confirmed diagnosis of any of the following:
    • a. Diffuse large B-cell lymphoma not otherwise specified

    Exclusion Criteria

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

    Clinical Study Locations

    Location
    Status
    Location
    MEDICAL UNIVERSITY PLOVDIV
    PLOVDIV, Bulgaria, 04000
    Status
    Recruiting
    Location
    SPECIALIZED HOSPITAL FOR ACTIVE TREATMENT OF ONCOLOGICAL DISEASES - SOFIA DISTRICT EOOD
    SOFIA, Bulgaria, 01756
    Status
    Recruiting
    Location
    UMHAT ALEXANDROVSKA SOFIA
    SOFIA, Bulgaria, 01431
    Status
    Recruiting
    Location
    UMHAT SV. IVAN RILSKI EAD
    SOFIA, Bulgaria, 01431
    Status
    Recruiting
    Location
    ACIBADEM CITYCLINICA MHAT TOKUDA
    SOFIA, Bulgaria, 01407
    Status
    Recruiting
    Location
    FAKULTNI NEMOCNICE OLOMOUC
    OLOMOUC, Czech Republic, 779 00
    Status
    Recruiting

    Protocol Summary

    Incyte Study ID:
    INCMOR 0208-305
    Primary Purpose:
    Treatment
    Allocation:
    N/A
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    82
    Primary Outcome
    Open

    Overall Response Rate (ORR)

    Timeframe: Approximately 24 months

    Secondary Outcome
    Open

    Duration of Response (DOR)

    Timeframe: Approximately 24 months

    Progression Free Survial (PFS)

    Timeframe: Approximately 24 months

    Disease Control Rate (DCR)

    Timeframe: Approximately 24 months

    Time to Next Treatment (TTNT)

    Timeframe: Approximately 24 months

    Overall Survival (OS)

    Timeframe: Approximately 24 months

    Number of treatment-emergent adverse events

    Timeframe: Approximately 24 months