Bendamustine, ofatumumab and ibrutinib treatment for chronic lymphocytic leukemia with high tumor load

This study aimed to investigate if the bendamustine debunking (reducing tumor size) followed by ofatumumab and ibrutinib treatment was safe and effective in patients with chronic lymphocytic leukemia and a high tumor load.  

This study concluded that this treatment was safe and effective in these patients.  

Targeted therapies have advanced the treatment of chronic lymphocytic leukemia (CLL). However, only a few patients achieve complete remission (CR) and minimal residual disease (MRD) negativity with ibrutinib (Imbruvica) alone. MRD is the small number of cancer cells that remain after treatment.   

Bendamustine (Treanda) is a chemotherapy drug used in the treatment of CLL. Ofatumumab (Arzerra) is a targeted therapy that has recently received approval for use in treatment of CLL. Ibrutinib is a targeted therapy that can be used to treat CLL. 

It was unknown if the combination of bendamustine, ofatumumab and ibrutinib would provide good outcomes for patients with CLL and a high tumor load. 

This study involved 65 patients with CLL. 60% of patients had not received any treatment for CLL before and 40% of patients had relapsed/unresponsive CLL. 32% of patients had genetic abnormalities and 69% did not. Patients received two cycles of bendamustine for debulking (reducing tumor before other treatment) followed by ofatumumab and ibrutinib induction and maintenance treatment. The main outcome measured was the overall response rate (ORR) at the end of induction treatment.  

At the end of induction, 92% of patients responded to treatment and 14% achieved MRD negativity. It was estimated that after 15 months, 97% of patients would survive without cancer progression. 

No unexpected toxicities occurred. The most common side effects were neutropenia (low level of white blood cells), anemia (low-level red blood cells), infusion-related reactions and diarrhea. 

This study concluded that bendamustine debulking, followed by ofatumumab and ibrutinib was safe and effective in patients with CLL and a high tumor load. 

This study had a small number of participants. Further larger studies are needed.