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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07502872 | TPG: Tafasitamab, Polatuzumab Vedotin, and Glofitamab as First-line Therapy for Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma | PHASE2 | NOT YET_RECRUITING | 30 | — | — | May 1, 2026 | Dec 1, 2029 | Mar 31, 2026 | 1 | United States |
• Complete response (CR) rate after 4 cycles of TPG therapy, evaluated by PET-CT using Lugano criteria
Occurrence and severity of adverse events will be examined throughout the treatment using the Common Terminology Criteria for Adverse Events (CTCAE) v6.0, except cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) will be assessed using the American Society of Transplantation and Cellular Therapy (ASTCT) criteria
| Arm | Type | Description |
|---|---|---|
| TPG therapy | EXPERIMENTAL | All enrolled patients will receive the same study therapy for the first four 21-day cycles, followed by the primary endpoint evaluation, and subsequent response-adapted therapy. After 4 cycles, the primary endpoint will be assessed by using positron emission tomography/computed tomography (PET-CT) based Lugano criteria. Subsequent therapy will be determined at that time, guided by the response assessment. Patients in complete response or with a partial metabolic response and a negative minimal residual disease (MRD) assay will continue with subsequent cycles of TPG immunotherapy. Patients who do not achieve these criteria will transition to standard immunochemotherapy, which will be delivered according to institutional standards. |
| Name | Type | Description |
|---|---|---|
| Tafasitamab | DRUG | Cytolytic monoclonal antibody targeting CD19. |
| Polatuzumab vedotin | DRUG | CD79b-targeting antibody-drug conjugate |
| Glofitamab | DRUG | CD20xCD3 bispecific antibody |
| Obinutuzumab | DRUG | Anti-CD20 monoclonal antibody |
Inclusion Criteria: 1. Ability to understand and the willingness to sign a written informed consent document and to comply with the study protocol procedures. 2. Age ≥18 years. 3. Histologically confirmed diagnosis of DLBCL, or HGBL, according to 5th edition WHO classification. Eligible WHO entitie...