Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05429268 | Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND) | PHASE3 | ACTIVE NOT_RECRUITING | 82 | — | — | Dec 23, 2022 | Apr 1, 2027 | May 5, 2026 | 61 | Bulgaria, Croatia +12 |
| NCT06760156 | Tafasitamab and Lenalidomide as First Salvage Therapy for Residual Large B Cell Lym | PHASE2 | RECRUITING | 28 | — | — | Mar 19, 2025 | Jan 1, 2028 | Apr 3, 2026 | 1 | United States |
Percentage of participants having best response of Complete Response (CR) or Partial Response (PR) as per Independent Review Committee and investigator's assessment.
Complete Response Rate (CRR) is defined as the proportion of patients with a Complete Response (CR)
| Arm | Type | Description |
|---|---|---|
| Tafasitamab and Lenalidomide | EXPERIMENTAL | 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 and Lenalidomide Treatment | EXPERIMENTAL | Participants will receive the study drug, Tafasitamab, intravenously on a weekly basis for the first three 28-day cycles (Cycles 1-3) and then every 2 weeks starting at Cycle 4 onwards. Participants will take the study drug, Lenalidomide, once daily for 21 days out of each 28-day cycle for 6 cycles. |
| Name | Type | Description |
|---|---|---|
| Tafasitamab | DRUG | 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. |
| Lenalidomide | DRUG | Participants will self-administer lenalidomide capsules orally on Days 1-21 of each 28-day cycle, up to 12 cycles. |
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 lymp...