
"I am glad that taking part in a trial might help others on their own cancer journey.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at new combinations of treatment for acute lymphoblastic leukaemia (ALL). In particular, it is looking at treatments for adults between 25 and 65 years old who have recently been diagnosed with acute lymphoblastic leukaemia, and for people between 19 and 65 who have ALL with the Philadelphia chromosome.
This trial is supported by Cancer Research UK.
Doctors usually treat acute lymphoblastic leukaemia (ALL), including ALL with the , with several different chemotherapy drugs. They often use high doses of chemotherapy, sometimes alongside a stem cell transplant.
In this trial, the research team are looking at changing the treatment in several different ways. They are
The aim of this trial is to see if they can improve treatment for adults with ALL.
Please note - part of the trial also looked at comparing 2 doses of a drug called palifermin to see if it helped stop people having a stem cell transplant getting a sore mouth (mucositis). But from April 2016, this treatment was no longer included in this trial.
You can enter this trial if you
You cannot enter this trial if you
This is a phase 3 trial and will recruit about 720 people. The trial team estimate that about 4 out of 5 people taking part will have B cell ALL, and 1 out of 5 will have T cell ALL.
Some parts of the trial are randomised. The people taking part will be put into groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
Treatment for leukaemia is intensive and will last for several months. It is too complicated to go into detail here, but below is an outline of the trial. Your doctor will be able to tell you more about it.
The first part of treatment for leukaemia is called remission induction. The aim is to destroy the leukaemia cells.
Everyone taking part will have several chemotherapy drugs as part of induction. Those with B cell ALL will be randomised to have rituximab or no rituximab. And those with T cell ALL will be randomised to have nelarabine or no nelarabine.
Treatment after that depends on factors such as how well the induction treatment works, and how old you are when you join the trial. Below, there is a brief summary of treatment for different situations.
If your ALL goes away completely, you have a brother or sister who can donate stem cells, and are 40 or younger, you will have intense chemotherapy followed by a stem cell transplant. Some people also had the growth factor palifermin before their transplant, but this treatment is no longer part of this trial.
If your ALL goes away completely, you have a brother or sister who can donate stem cells, and are over 40, you will have less intense chemotherapy followed by a stem cell transplant.
If tests show that there is a high risk that your ALL will come back, you don’t have a brother or sister to donate stem cells, and you are 40 or less, you will have intensive chemotherapy followed by a stem cell transplant using stem cells from a donor you are not related to (a MUD, or matched unrelated donor transplant). Some people were randomised to have the growth factor palifermin. But they won't be giving this treatment to any more people as part of this trial.
If tests show that there is a high risk that your ALL will come back, you don’t have a brother or sister who can donate stem cells, and you are over 40, you will have less intensive chemotherapy and then a matched unrelated donor (MUD) stem cell transplant.
If tests show that there is a medium risk (or standard risk) that your ALL will come back, you will have chemotherapy in 2 parts. They are called consolidation (to stop the leukaemia coming back) and maintenance (to keep the leukaemia away long term).
You will see the doctors and have some tests before you join the trial. The tests include
You will see the doctors and have blood and bone marrow tests regularly during and after your treatment. If you have a stem cell transplant you will also have a CT scan.
If you are in the ‘standard risk’ group you will see the doctors every 3 months during maintenance treatment, and then yearly once you finish treatment. If you have a stem cell transplant, you will see the doctors every 3 months for 2 years, and then yearly after that.
Treatment for leukaemia is very intensive and you are likely to be in hospital on and off for several months whether you take part in this trial or have ‘standard’ treatment.
The side effects of treatment for acute lymphoblastic leukaemia can be severe. But that is likely to be the case whether you take part in this trial or not.
The chemotherapy drugs used to treat ALL include daunorubicin, vincristine, methotrexate, asparaginase, cyclophosphamide, cytarabine and etoposide. The most common side effects of these drugs are
The most common side effects of rituximab (Mabthera) include
The most common side effects of nelarabine (Atriance) include
The most common side effects of a stem cell transplant are
There is more about side effects of treatment for ALL and you will find more information about side effects of specific drugs if you click on the links above.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Adele Fielding
Cancer Research UK
Cancer Research UK & UCL Cancer Trials Unit
Chugai Pharma UK Ltd
Baxalta
Novartis Pharmaceuticals UK Ltd
NIHR Clinical Research Network: Cancer
Roche
Sigma Tau
Swedish Orphan Biovitrum
This is Cancer Research UK trial number CRUK/09/006.
We have more information on the work of Professor Adele Fielding.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”