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

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Acute leukaemia
Acute lymphoblastic leukaemia (ALL)
Blood cancers




Phase 1/2

This study is looking at the safety of adding the drugs veltuzumab and epratuzumab to chemotherapy to treat acute lymphoblastic leukaemia (ALL) that has either not responded to treatment, or has come back. This study is supported by Cancer Research UK.

The main treatment for acute lymphoblastic leukaemia is chemotherapy. If tests after treatment show that you have no leukaemia cells in your blood and bone marrow, doctors say that your leukaemia is in remission Open a glossary item. If it comes back after this, it is called a relapse Open a glossary item. If tests show that you still have high numbers of leukaemia cells in your blood and bone marrow Open a glossary item after treatment, doctors say that your leukaemia is refractory Open a glossary item. Doctors would like to improve treatment for ALL that has relapsed or is refractory.

This study is looking veltuzumab and epratuzumab, which are biological therapies called monoclonal antibodies. Monoclonal antibodies 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 have been studied in clinical trials with chemotherapy, but not in people with ALL. The main aim of this study is to see if adding veltuzumab and epratuzumab to treatment for relapsed ALL is safe. If it is, researchers will plan further trials to help improve the treatment of people with ALL.

Who can enter

You can enter this study if you

  • Have a type of acute lymphoblastic leukaemia (ALL) called Pre (precursor) B cell ALL
  • Had treatment which put your ALL into remission Open a glossary item, but it has come back (your ALL has relapsed) or had treatment for your ALL, but it didn't respond (your ALL is refractory)
  • Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Have satisfactory blood tests
  • Are willing to use reliable contraception during the study treatment and for 3 months afterwards if there is any chance that you or your partner could become pregnant
  • Are at least 16 years old

You cannot enter this study if you have either

  • Had treatment for relapsed ALL (you can still take part if you have taken steroids for fewer than 10 days - please note, you must not stop taking steroids without talking to your doctor first) OR
  • Had chemotherapy in the last 7 days for ALL that has not responded to treatment (refractory ALL), or have not recovered from any side effects of your previous chemotherapy

OR you

  • Have ALL that is Philadelphia chromosome Open a glossary item positive, and you have either not had treatment with a type of drug called a tyrosine kinase inhibitor, or tests show that the number of Philadelphia positive cells that you have has increased after treatment, but this has not yet caused any symptoms
  • Have had treatment with a monoclonal antibody in the last 3 months
  • Have high blood pressure, diabetes, or any other condition which could make you unwell or affect the results of the study – you can check this with your doctor
  • Are having medication as part of another clinical trial
  • Are pregnant or breastfeeding

Trial design

This phase 1/2 study will recruit up to 55 people. You will be put into one of 3 possible groups, depending on when you join the study. The first 2 groups are part of phase 1. If results are promising from this phase, the study team will move to phase 2 and open a third group. Everyone will have the same chemotherapy with either veltuzumab or epratuzumab, or both, depending on the group you are in.

The chemotherapy you have will be one that doctors often use to treat ALL that has come back or has not responded to treatment. Everyone will have one cycle of treatment which takes 29 days. You have

Also, you may have 1 or 2 doses of peg-asparaginase (or a similar drug) either through a drip into a vein, or as an injection into a muscle on days 4 and 18 (whether you have this at all, or the number of doses you have, depends on your age, treatments you have had already and how your leukaemia responded to them).

If you are in group 1, you will have veltuzumab with your chemotherapy. If you are in group 2, you have epratuzumab with your chemotherapy. People in group 3 will have both.

You have veltuzumab or epratuzumab or both as a slow drip (infusion) into a vein, on days 8, 15, 22 and 29 of your chemotherapy cycle. If you are in group 3 you have both drugs on these days, one after the other.

You will have regular blood and urine tests throughout the study.

After the study you continue to see your usual leukaemia doctors in the same way as you did before. With your permission, the study team will check your medical notes regularly for 2 years to see how you are getting on.

Hospital visits

Before you start treatment, you will see the doctor and have some tests. These tests include

You will have blood and urine tests regularly throughout the study, when you come for treatment.

At the end of your treatment you will repeat most of the tests you had at the start.

About 2 months after starting treatment you will see the study doctor and have a blood test. The study team will bring this appointment forward if you are due to start another treatment.

The tests and visits you have for the study are the same as if you were having the chemotherapy for relapsed or refractory ALL outside of the study. But you will give more samples at these visits than you would if you were not in the study.

Side effects

Side effects of veltuzumab and epratuzumab include

You may have a bruise where you have your blood tests. You may also have some bleeding after your bone marrow biopsy.

We have more information about the side effects of vincristine, asparaginase, dexamethasone and methotrexate.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Matthew Smith

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Immunomedics Inc
NIHR Clinical Research Network: Cancer
Queen Mary University of London

Other information

This is Cancer Research UK trial number CRUK/08/040.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 4550

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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