The Lancet, Feb22nd 2021. Jeff P Sharman, Mato et al
Patients with chronic lymphocytic leukaemia and high-risk features (TP53mutated, 11qdel, and 17p del) have poorer outcomes on ibrutinib than those without high-risk features. The aim of this study was to assess the benefit of adding ublituximab, an anti-CD20 monoclonal antibody, to ibrutinib therapy in this population.
126 patients were enrolled and randomly assigned to receive ublituximab plus ibrutinib (n=64) or ibrutinib alone (n=62) between Feb 6, 2015, and Dec 19, 2016. After a median follow-up of 41·6 months (IQR 36·7–47·3), the overall response rate was 53 (83%) of 64 patients in the ublituximab plus ibrutinib group and 40 (65%) of 62 patients in the ibrutinib group (p=0·020). Remember these are relapsed and refractory patients.
Two patients in the ublituximab plus ibrutinib group died due to adverse events (one cardiac arrest and one failure to thrive), neither of which were treatment-related. Five patients in the ibrutinib group died due to adverse events, including one cardiac arrest, one cerebral infarction, one intracranial haemorrhage, one Pneumocystis jirovecii pneumonia infection, and one unexplained death; the death due to cardiac arrest was considered to be treatment-related.
The addition of ublituximab to ibrutinib resulted in a statistically higher overall response rate without affecting the safety profile of ibrutinib monotherapy in patients with relapsed or refractory high-risk chronic lymphocytic leukaemia.
This is very exciting! TY for posting this. I am wondering if we will see future trends of multi therapy regimens with slightly lower doses (to minimize side effects) to improve outcomes & prevent cancer resistance.
You say relapsed is had one prior treatment but what was there prior treatment ? Had any been on inbrutinib mono therepy before and then on this trial added the cd 20 ? Thanks Jackie
ECOG score 0-2 is actually the fitter groups of patients not the more frail ones.
GRADE ECOG PERFORMANCE STATUS
0 Fully active, able to carry on all pre-disease performance without restriction
1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
2 Ambulatory and capable of all self care but unable to carry out any work activities; up and about more than 50% of waking hours
3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
Jackie,Using it for children would be so sad and tragic. It was often the admitting diagnosis for nursing home patients in the hospital that I worked at.
But I looked it up and you are correct that it is commonly used for infants and small children 😢
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