A trial looking at fludarabine and cyclophosphamide with or without rituximab for chronic lymphocytic leukaemia (REACH BO 17072)

Cancer type:

Blood cancers

Chronic leukaemia

Chronic lymphocytic leukaemia (CLL)

Leukaemia

Status:

Results

Phase:

Phase 3

This trial looked at whether giving rituximab (Mabthera) as well as fludarabine and cyclophosphamide is a useful treatment for chronic lymphocytic leukaemia (CLL).

Doctors often treat CLL with chemotherapy. But unfortunately it doesn’t always work very well, and sometimes the leukaemia starts to grow again.

Doctors often use the chemotherapy drugs fludarabine and cyclophosphamide to treat CLL that has not responded to treatment, or has started to grow again.

In this trial, some people had a biological therapy called rituximab (Mabthera) as well as chemotherapy. Doctors hoped that rituximab, fludarabine and cyclophosphamide would be better than just fludarabine and cyclophosphamide.

The aim of the trial was to see which combination of treatment is better for CLL that has not responded to treatment, or has come back after treatment.

Summary of results

The research team found that giving rituximab combined with fludarabine and cyclophosphamide was helpful for chronic lymphocytic leukaemia (CLL).

This trial recruited 552 people with CLL that had not responded to treatment or had come back after treatment. Of these

276 had fludarabine and cyclophosphamide (FC)
276 had rituximab, fludarabine and cyclophosphamide (R-FC)

The research team looked at how long it was before the leukaemia came back. The average time was

Nearly 21 months for people who had FC
Nearly 31 months for people who had R-FC

They also looked at how many people in each group responded to treatment. They found that

58 out of 100 people (58%) who had FC responded to treatment, and the leukaemia went away completely in 13% (this means that it could not be detected with routine blood and bone marrow tests)
70 out of 100 people (70%) who had R-FC responded to treatment, and the leukaemia went away completely in 24%

A few more people in the R-FC group had side effects, including some serious side effects, but not many more than in the FC group. The most common side effect was a drop in blood cells.

The research team concluded that the combination of rituximab, fludarabine and cyclophosphamide (R-FC) was useful and safe for CLL.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.