Inotuzumab ozogamicin and mini-hyper-CVD with or without blinatumomab in relapsed/refractory acute lymphoblastic leukemia

This study aimed to investigate the combination of inotuzumab ozogamicin (InO; Besponsa) and mini-hyper-CVD (cyclophosphamide and dexamethasone at 50% dose reduction, no anthracycline, methotrexate at 75% dose reduction, cytarabine at 0.5 g/m2  x 4 doses) with or without blinatumomab (Blincyto) in patients with relapsed/refractory (r/r) acute myeloid leukemia (ALL).  

This study concluded that this combination was effective in these patients.  

Patients with r/r ALL have poorer outcomes. New combinations are needed for these patients. InO and blinatumomab are immunotherapies that have shown good responses in patients with r/r ALL. Low-intensity mini-hyper-CVD involves reduced doses of chemotherapy. The combination of InO and low-intensity mini-hyper-CVD has previously shown good responses in the short term.

However, it was unknown if adding blinatumomab to InO and mini-hyper-CVD would improve outcomes over longer term for patients with r/r ALL. 

This study involved 96 patients with R/R ALL. Patients were treated with InO and low-intensity mini-hyper-CVD. Some patients received blinatumomab in addition. The average follow-up period was 36 months.

80% of patients had a response to therapy and 57% of these achieved a complete response (CR; no signs of cancer). In patients who responded to treatment, 83% did not have any measurable residual disease (no cancer cells left after treatment).

10% of patients experienced veno-occlusive disease (VOD). VOD is when the blood vessels into and inside the liver become blocked.  

This study concluded that the combination of InO and low-intensity mini-hyper-CVD chemotherapy with or without blinatumomab showed sustained effectiveness in patients with r/r ALL. 

Patients were not randomly assigned to blinatumomab. There was no comparison with other regimens. Further studies are needed.