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History of Changes for Study: NCT05429268
Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND) (firmMIND)
Latest version (submitted May 2, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 17, 2022 None (earliest Version on record)
2 September 13, 2022 Study Status
3 November 7, 2022 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 November 14, 2022 Contacts/Locations and Study Status
5 November 15, 2022 Contacts/Locations and Study Status
6 January 12, 2023 Study Status and Contacts/Locations
7 June 7, 2023 Contacts/Locations and Study Status
8 June 23, 2023 Contacts/Locations and Study Status
9 June 30, 2023 Contacts/Locations and Study Status
10 August 17, 2023 Study Status and Contacts/Locations
11 August 31, 2023 Contacts/Locations and Study Status
12 September 6, 2023 Contacts/Locations and Study Status
13 September 27, 2023 Contacts/Locations and Study Status
14 October 3, 2023 Study Status and Contacts/Locations
15 October 18, 2023 Contacts/Locations and Study Status
16 November 14, 2023 Study Status and Contacts/Locations
17 November 21, 2023 Contacts/Locations and Study Status
18 November 29, 2023 Contacts/Locations and Study Status
19 January 31, 2024 Study Status and Contacts/Locations
20 March 13, 2024 Study Status and Contacts/Locations
21 April 18, 2024 Study Status and Contacts/Locations
22 May 2, 2024 Study Status and Contacts/Locations
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Study NCT05429268
Submitted Date:  June 17, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: INCMOR 0208-305
Brief Title: Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND) (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
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2022
Overall Status: Not yet recruiting
Study Start: August 24, 2022
Primary Completion: December 16, 2026 [Anticipated]
Study Completion: December 16, 2026 [Anticipated]
First Submitted: June 17, 2022
First Submitted that
Met QC Criteria:
June 17, 2022
First Posted: June 23, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
June 17, 2022
Last Update Posted: June 23, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Incyte Corporation
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma
Keywords: MOR00208
INCMOR00208
tafasitamab
lenalidomide
firmMIND
Diffuse Large B-Cell Lymphoma
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Single Group Assignment
Single-arm, open-label, multicenter
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 81 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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:
  • INCMOR00208
  • MOR00208
Drug: Lenalidomide
Participants will self-administer lenalidomide capsules orally on Days 1-21 of each 28-day cycle, up to 12 cycles.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
Secondary Outcome Measures:
1. 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.
2. 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.
3. 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.
4. 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.
5. Overall Survival (OS)
[ Time Frame: Approximately 24 months ]

Defined as the time from the date of first dose until death due to any cause.
6. 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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 99 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Incyte Corporation Call Center (US)
Telephone: 1.855.463.3463
Email: globalmedinfo@incyte.com
Central Contact Backup: Incyte Corporation Call Center (ex-US)
Telephone: +800 00027423
Email: eumedinfo@incyte.com
Study Officials: Oliver Manzke, MD
Study Director
Incyte Corporation
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services