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 : November 24, 2023
|Condition or disease||Intervention/treatment||Phase|
|Large B-Cell Lymphoma Diffuse Large B-Cell Lymphoma||Drug: Tafasitamab Drug: Lenalidomide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||81 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single-arm, open-label, multicenter|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||December 23, 2022|
|Estimated Primary Completion Date :||December 24, 2025|
|Estimated Study Completion Date :||December 24, 2026|
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.
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.
Participants will self-administer lenalidomide capsules orally on Days 1-21 of each 28-day cycle, up to 12 cycles.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05429268
|Contact: Incyte Corporation Call Center (US)||firstname.lastname@example.org|
|Contact: Incyte Corporation Call Center (ex-US)||+800 email@example.com|
|Study Director:||Oliver Manzke, MD||Incyte Corporation|