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Posted by on Feb 28, 2019 in Non-Hodgkin lymphoma | 0 comments

In a nutshell

This study aimed to investigate the safety and effectiveness of ibrutinib (Imbruvica) combined with umbralisib for patients with released/unresponsive mantle cell lymphoma (MCL). This study concluded that the combination of umbralisib and ibrutinib is well tolerated and effective in these patients. 

Some background

Mantle cell lymphoma (MCL) is a type of non-Hodgkin's lymphoma. It is often treated with targeted therapy such as ibrutinib. However, some patients do not get a lasting benefit from this treatment. Umbralisib is an experimental targeted therapy. 

It was not known if umbralisib used along with ibrutinib in patients with relapsed/unresponsive MCL would be safe and effective.

Methods & findings

This study involved 42 patients with blood cancers. 21 patients had relapsed/unresponsive MCL. Patients had an average of two previous treatments. Patients received umbralisib once a day in a dose of 400, 600 or 800mg. All patients also received 560mg ibrutinib once a day. Patients were treated until disease progression or unacceptable side effects.

No dose-limiting side effects were observed. The maximum tolerated dose of umbralisib was not reached. The maximum tolerated dose is the highest dose of a drug that does not cause unacceptable side effects. The recommended dose of umbralisib when given in combination with ibrutinib was 800mg once a day.

The most common side effects were diarrhea, nausea, infection, and fatigue. Serious side effects occurred in 29% of the 42 patients. These included lipase elevation (damage to pancreatic cells), abnormal heartbeat and low level of phosphate in the blood causing weakness and breathing problems. 

Overall, 67% of the 21 patients with MCL responded to treatment. The average survival without cancer growing or spreading for patients with MCL after 2 years was 49%. The average 2-year overall survival was 58%.

The bottom line

This study concluded that the combination of umbralisib and ibrutinib is well tolerated and effective in relapsed/unresponsive MCL. 

The fine print

This was the first study of its kind, with a small number of patients. Further studies are needed to test this treatment combination.

Published By :

The Lancet. Haematology

Date :

Dec 14, 2018

Original Title :

Umbralisib in combination with ibrutinib in patients with relapsed or refractory chronic lymphocytic leukaemia or mantle cell lymphoma: a multicentre phase 1-1b study.

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