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

• ClinicalTrials.gov Identifier: NCT05429268
• Recruitment Status: Recruiting
• First Posted: June 23, 2022
• Last Update Posted: May 3, 2024
• Sponsor: Incyte Corporation
• Information provided by (Responsible Party): Incyte Corporation

Tracking Information

• First Submitted Date: June 17, 2022
• First Posted Date: June 23, 2022
• Last Update Posted Date: May 3, 2024
• Actual Study Start Date: December 23, 2022
• Estimated Primary Completion Date: December 24, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)
• 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
• 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: Interventional
• Study Phase: Phase 3

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Single-arm, open-label, multicenter

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Large B-Cell Lymphoma
• Diffuse Large B-Cell Lymphoma

Intervention

• 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

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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 17, 2022): 81
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 24, 2026
• Estimated Primary Completion Date: December 24, 2025 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 99 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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: Bulgaria, Croatia, Czechia, Denmark, Finland, Hungary, Ireland, Israel, Norway, Poland, Romania, Serbia, Turkey, United Kingdom

Administrative Information

• NCT Number: NCT05429268
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Incyte Corporation
• Original Responsible Party: Same as current
• Current Study Sponsor: Incyte Corporation
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Oliver Manzke, MD; Incyte Corporation

• PRS Account: Incyte Corporation
• Verification Date: May 2024