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

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ClinicalTrials.gov Identifier: NCT05429268
Recruitment Status : Recruiting
First Posted : June 23, 2022
Last Update Posted : June 6, 2024
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE June 17, 2022
First Posted Date  ICMJE June 23, 2022
Last Update Posted Date June 6, 2024
Actual Study Start Date  ICMJE December 23, 2022
Estimated Primary Completion Date December 24, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2022)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2022)
  • 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.
  • 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.
  • 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.
  • 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.
  • Overall Survival (OS) [ Time Frame: Approximately 24 months ]
    Defined as the time from the date of first dose until death due to any cause.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Single-arm, open-label, multicenter
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Large B-Cell Lymphoma
  • Diffuse Large B-Cell Lymphoma
Intervention  ICMJE
  • 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:
    • INCMOR00208
    • MOR00208
  • Drug: Lenalidomide
    Participants will self-administer lenalidomide capsules orally on Days 1-21 of each 28-day cycle, up to 12 cycles.
Study Arms  ICMJE 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.
Interventions:
  • Drug: Tafasitamab
  • Drug: Lenalidomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 17, 2022)
81
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 24, 2026
Estimated Primary Completion Date December 24, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Incyte Corporation Call Center (US) 1.855.463.3463 globalmedinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 eumedinfo@incyte.com
Listed Location Countries  ICMJE Bulgaria,   Croatia,   Czechia,   Denmark,   Finland,   Hungary,   Ireland,   Israel,   Norway,   Poland,   Romania,   Serbia,   Turkey,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05429268
Other Study ID Numbers  ICMJE INCMOR 0208-305
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Incyte Corporation
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Incyte Corporation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Oliver Manzke, MD Incyte Corporation
PRS Account Incyte Corporation
Verification Date June 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP