Table 3.
Summary of Ongoing Trials for Treatment of B-ALL with Blinatumomab
| Title | Trial Details | Preliminary Results |
|---|---|---|
| Phase II Study of Blinatumomab in Patients with B-Cell Acute Lymphoblastic Leukemia (B-ALL) with Positive Measurable Residual Disease (MRD) | Eligible adult patients have MRD 10−4 or greater. Ph- patients receive single agent blinatumomab. Ph+ patients receive blinatumomab plus TKI | MRD negativity achieved in 75% of Ph+ patients and 80% of Ph- patients for first 25 patients enrolled. No significant difference in 2 year RFS or OS by Ph status.31 |
| Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia (NCT02003222) | Phase III trial. Adults with newly diagnosed Ph- disease are randomized to receive induction, intensification, consolidation, and maintenance therapy either with or without blinatumomab | |
| Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia (NCT02143414) | Phase II trial in adults 65 and older. Newly diagnosed Ph- patients receive blinatumomab + POMP. Newly diagnosed Ph+, R/R Ph+ and Ph-like patients receive blinatumomab, dasatinib, and prednisone | 66% CR/Cri rate for newly diagnosed Ph- patients treated with blinatumomab + POMP.40 |
| Dasatinib-Blinatumomab Combination for the Front-Line Treatment of Adult Ph+ ALL Patients. Updated Results of the Gimema LAL2116 D-Alba Trial. | Ongoing phase II multicenter study combining blinatumomab with dasatinib for frontline therapy in patients with Ph+ B-ALL. | Molecular response in 80% of patients after 4 cycles of blinatumomab with a 12 month OS and disease free survival of 94.2% and 87.8%.41 |
| Inotuzumab Ozogamicin and Blinatumomab in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia (NCT03739814) | Phase II trial. Adults with newly diagnosed or R/R CD22+, Ph- disease are treated with inotuzumab followed by blinatumomab | |
| Updated Results from the Phase II Study of Hyper-CVAD in Sequential Combination with Blinatumomab in Newly Diagnosed Adults with B-Cell Acute Lymphoblastic Leukemia (B-ALL). | Adults with newly diagnosed disease receive sequential hyper-CVAD and blinatumomab followed by maintenance POMP plus blinatumomab. | 100% CR rate with 96% achieving MRD negativity of 10−4 or less in first 27 patients. 12 month estimated RFS 76% and OS 89%.42 |
| Preliminary Minimal Residual Disease Analysis of the Australasian Leukaemia & Lymphoma Group (ALLG) ALL8 Study of Front-Line Blinatumomab with Chemotherapy in Adults with Ph Negative B-Cell Acute Lymphoblastic Leukaemia | Phase II trial. Adults with newly diagnosed disease receive blinatumomab alternating with part B hyper-CVAD | Seven of the first ten patients achieved MRD of 10−4 or greater by completion of one consolidation cycle.43 |
| Blinatumomab and Nivolumab With or Without Ipilimumab in Treating Patients With Poor-Risk Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia (NCT02879695) | Phase I trial. Adults with poor-risk, relapsed, or refractory disease are treated with blinatumomab plus either single agent nivolumab or combination nivolumab/ipilimumab | |
| Blinatumomab and Pembrolizumab for Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia With High Marrow Lymphoblasts (NCT03160079) | Phase I/II Trial. Adults with R/R disease and ≥50% blasts in bone marrow are treated with blinatumomab plus pembrolizumab | |
| Pembrolizumab and Blinatumomab in Treating Participants with Recurrent or Refractory Acute Lymphoblastic Leukemia(NCT03512405) | Phase I/II Trial. Adults with R/R disease receive blinatumomab plus pembrolizumab | |
| Pembro + Blina Combination in Pediatric and Young Adult Patients with Relapsed/Refractory Acute Leukemia or Lymphoma (NCT03605589) | Pilot study of blinatumomab plus pembrolizumab in patients age 1–40 with R/R CD19 positive B-ALL or Lymphoma |