A study looking at adding treatment to chemotherapy for acute lymphoblastic leukaemia that has not responded, or has come back after treatment (MARALL)

Cancer type:

Acute leukaemia

Acute lymphoblastic leukaemia (ALL)

Leukaemia

Status:

Results

Phase:

Phase 1/2

This study looked at veltuzumab and epratuzumab with chemotherapy for acute lymphoblastic leukaemia (ALL) that has not responded to treatment, or has come back. This study was supported by Cancer Research UK.

More about this trial

The main treatment for acute lymphoblastic leukaemia is chemotherapy. Your leukaemia is in remission Open a glossary item if tests after treatment show that you have no leukaemia cells in your blood and bone marrow .

Your leukaemia is refractory Open a glossary item if tests show that you still have high numbers of leukaemia cells in your blood and bone marrow after treatment. A relapse is when it comes back after treatment. Doctors would like to improve treatment for ALL that has relapsed or is refractory.

This study looked at two treatments called veltuzumab and epratuzumab. They are both types of targeted cancer drugs called monoclonal antibodies. Monoclonal antibodies are a type of immunotherapy. They can seek out cancer cells by looking for particular proteins on the cell’s surface.

Veltuzumab seeks out a protein called CD20, and epratuzumab looks for the CD22 protein. When these antibodies attach to the protein, they kill the cell.

Veltuzumab and epratuzumab had already been studied in clinical trials, but not in people with ALL.

The main aim of this study was to see if adding veltuzumab and epratuzumab to chemotherapy for relapsed ALL is safe.

Summary of results

This trial recruited 27 people with acute lymphoblastic leukaemia (ALL). They’d all had treatment for their leukaemia already.

The research team had hoped to recruit more people, but the pharmaceutical company were unable to supply enough veltuzumab. So unfortunately they had to stop the trial earlier than planned. They were still able to do some analysis, and these are the results.

Of the 27 people who took part:

3 people had veltuzumab and chemotherapy (group A)
3 people had epratuzumab and chemotherapy (group B)
21 people had veltuzumab, epratuzumab and chemotherapy (group C)

The research team looked at the side effects of people in group C. They found that 7 out of 21 people (33%) had side effects caused by the treatment that could be classed as serious. The side effects were varied, and included a blood clot, liver changes and infection or fever. Another 7 people taking part had problems that were not related to the trial treatment.

The team also looked at how well the treatment worked in 20 of the people in group C. They found that the ALL had gone away completely in 8 out of 20 people (40%). Doctors call this complete remission.

They are unable to draw any firm conclusions because of the small number of patients who took part in the trial.

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item

) but may not have been published in a medical journal. The figures we quote above were provided by the research team. We have not analysed the data ourselves.