Table 5 Ongoing clinical trials of blinatumomab in combination with other therapeutic approaches
From: The landscape of bispecific T cell engager in cancer treatment
Clinical Trials.gov identifier | Phase | Patient/Disease | Combination regimen | Class of combination drugs | Estimated enrollment | Primary endpoint | Status |
|---|---|---|---|---|---|---|---|
NCT04554485 | 2 | Adultswith newly diagnosed Ph-negative CD19+ B-ALL | Single cycle of blinatumomab followed by high-dose chemotherapy in the induction phase | Chemotherapy | 45 | CMR | Recruiting |
NCT03518112 | 2 | Adults with R/R Ph-negative B-ALL | Concurrent blinatumomab and low-intensity chemotherapy | Chemotherapy | 44 | EFS | Recruiting |
NCT03480438 | 2 | Older adults with newly diagnosed CD19+ Ph-negative B-ALL | Sequential dose reduced chemotherapy and blinatumomab | Chemotherapy | 50 | CHR and CMR | Recruiting |
NCT02877303 | 2 | Children and adults with newly diagnosed B-ALL | Sequential chemotherapy and blinatumomab | Chemotherapy | 60 | RFS | Recruiting |
NCT03523429 | 2 | Adults with high-risk CD19 + Ph-negative B-ALL | Blinatumomab added to consolidation phase with chemotherapy | Chemotherapy | 38 | MRD negative response | Recruiting |
NCT03541083 | 2 | Adults with newly diagnosed CD19+ B-ALL | Blinatumomab added to prephase and consolidation phase with chemotherapy | Chemotherapy | 80 | MRD negative response | Recruiting |
NCT03367299 | 2 | Adults with newly diagnosed or R/R CD19 + Ph-negative B-ALL | Sequential chemotherapy and blinatumomab | Chemotherapy | 149 | MRD negative response | Recruiting |
NCT03914625 | 3 | Children and adultswith newly diagnosed B-ALL | Addition of 2 cycles of blinatumomab to standard chemotherapy | Chemotherapy | 6720 a | DFS | Recruiting |
NCT02003222 | 3 | Adults with newly diagnosed Ph-negative B-ALL | Sequential chemotherapy and blinatumomab | Chemotherapy | 488 | OS | Active, not recruiting |
NCT02744768 | 2 | Adults with newly diagnosed Ph + B-ALL | Sequential dasatinib and blinatumomab | TKI | 60 | MRD negative response | Recruiting |
NCT02997761 | 2 | Adults with R/R Ph-negative B-ALL | Concurrent Ibrutinib and blinatumomab | TKI | 20 | CR | Recruiting |
NCT04530565 | 3 | Adults with newly diagnosed Ph + B-ALL | Concurrent TKI and blinatumomab | TKI | 330 | OS | Recruiting |
NCT04524455 | 1 | Adults with R/R B-ALL | Blinatumomab in combination with AMG 404 (anti-PD-1) | ICI | 21 | DLTs and toxicity | Recruiting |
NCT03605589 | 1 | Children and adults with R/R CD19+ Ph-negative B-ALL | Blinatumomab in combination with pembrolizumab (anti-PD-1) | ICI | 24 | DLTs and toxicity | Suspended |
NCT02879695 | 1 | Children and adults with poor-risk R/R CD19+ B-ALL | Blinatumomab in combination with nivolumab with or without ipilimumab (anti-CTLA-4) | ICI | 36 | Toxicity and MTD | Recruiting |
NCT03340766 | 1 | Adults R/R DLBCL | Blinatumomab in combination with pembrolizumab | ICI | 70 | DLTs | Recruiting |
NCT03160079 | 1/2 | Adultswith R/R CD19+ Ph-negative B-ALL with high marrow lymphoblasts (≥50%) | Blinatumomab in combination with pembrolizumab | ICI | 24 | ORR | Recruiting |
NCT03512405 | 1/2 | Adultswith R/R CD19+ B-ALL | Blinatumomab in combination with pembrolizumab | ICI | 36 | Toxicity and ORR | Recruiting |
NCT04546399 | 2 | Children and adults with first relapse CD19+ B-ALL | Blinatumomab in combination with nivolumab (anti-PD-1) | ICI | 550 | MRD negative second response and EFS | Recruiting |
NCT02143414 | 2 | Older adults with newly diagnosed Ph-negative B-ALL (Cohort 1) and Ph + B-ALL (Cohort 2) | Blinatumomab followed by chemotherapy (Cohort 1) or dasatinib followed by blinatumomab (Cohort 2) | Chemotherapy or TKI | 58 | DLTs and OS | Recruiting |
NCT03263572 | 2 | Adults with Ph + B-ALL | Concurrent blinatumomab, chemotherapy, and ponatinib | Chemotherapy and TKI | 60 | CMR, ORR, RFS, EFS, and OS | Recruiting |
NCT03147612 | 2 | Adults with Ph + B-ALL | Sequential low-Intensity chemotherapy and ponatinib followed by blinatumomab and ponatinib | Chemotherapy and TKI | 60 | CMR and ORR | Recruiting |
NCT02568553 | 1 | Adults with R/R CD19+ B-NHL | Concurrent lenalidomide and blinatumomab | Others | 44 | Toxicity | Recruiting |
NCT03751709 | 1 | Adults (≥18 years) with R/R CD19+ B-ALL | Blinatumomab in combination with HLA-Mismatched Cellular Therapy | Others | 10 | DLTs | Recruiting |
NCT03739814 | 2 | Adults with newly diagnosed or R/R CD22+ Ph-negative B-ALL | Inotuzumab ozogamicin followed by blinatumomab | Others | 64 | EFS | Recruiting |
NCT03982992 | 2 | Adults with treatment-resistant MC or MRD of CD19+ B-ALL after HSCT | Blinatumomab in combination with donor lymphocyte infusion | Others | 12 | Toxicity | Recruiting |