Welcome to Medivizor!

You're browsing our sample library. Feel free to continue browsing. You can also sign up for free to receive medical information specific to your situation.

Posted by on Feb 28, 2019 in Leukemia | 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 chronic lymphocytic leukemia (CLL).

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

Some background

Chronic lymphocytic leukemia (CLL) is often treated with ibrutinib. This is a targeted therapy used for CLL. But 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 CLL would be safe and effective.

Methods & findings

This study involved 42 patients with blood cancers. 21 patients had relapsed/unresponsive CLL. 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 420mg 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, 90% of the 21 patients with CLL responded to treatment. The average survival without cancer growing or spreading for patients with CLL after 2 years was 90%. The average 2-year overall survival was 95%.

The bottom line

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

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.

click here to get personalized updates