A study to find more about acute lymphoblastic leukaemia (UKALL14 sub study)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This study is open to people who are newly diagnosed with B cell or T cell acute lymphoblastic leukaemia (ALL) and haven’t started treatment. It is a sub study of the original UKALL14 trial.
In particular, it is for
- adults between 25 and 65 years old with B cell or T cell acute lymphoblastic leukaemia
- and for people between 19 and 65 who have ALL with the Philadelphia chromosome.
Cancer Research UK supports this study.
More about this trial
The UKALL14 trial is looking at different treatments for ALL.
The team would now like to do a sub study to find out more about the genes of the leukaemic cells. They also want to find out more about whether they can predict how well treatment will work based on these changes.
In this study you have the standard chemotherapy treatment for ALL at your hospital. The study team will ask for small amount of your bone marrow sample that is taken before starting your treatment.
They are looking for a substance (biomarker) in the sample they can use to follow how well your leukaemia responds to treatment. They are also looking for any gene changes in the cells of your leukaemia.
Who can enter
The following bullet points list the entry conditions for this study. Talk to your doctor or the study if you are unsure about any of these. They will be able to advise you.
You may be able to join this study if all of the following apply. You:
- have recently been diagnosed with acute lymphoblastic leukaemia (ALL) and have not yet had any treatment apart from steroids
- are between 25 and 65 years old (inclusive)
or
you are between 19 and 65 and you have ALL with the Philadelphia chromosome
You cannot join this study if any of these apply. You:
- have a mature B cell leukaemia such as Burkitt type ALL
- are in the blast transformation stage
- have chronic myeloid leukaemia (CML)
- are known to be HIV positive
- are known to have hepatitis B or hepatitis C
- are pregnant or breastfeeding
Trial design
The study team need about 250 people to join this study.
Samples
Before starting treatment you have a bone marrow sample. This is a routine sample. The study team will ask for a small amount of this sample.
The team will ask for a blood sample if there isn’t enough of the bone marrow sample for them.
You then have treatment as normal. The main treatment for ALL is chemotherapy. Your doctor will decide the best treatment for you. This is likely to be based on the standard treatment given at your local hospital.
There are different phases of ALL treatment:
- induction
- consolidation
- maintenance
You have your induction treatment in 2 parts. The team collect another bone marrow sample after each part of the treatment.
You might have a stem cell transplant or bone marrow transplant if you have a suitable donor and your ALL is at a high risk of coming back after chemotherapy.
If your leukaemia comes back (relapses) the team will take a bone marrow sample.
You give a sample of the cells from the inside of your cheek using a swab (a buccal swab). The team test the cells for gene changes. They want to identify the link between the gene changes and your type of cancer.
You don't have to agree to do the buccal swab.
Hospital visits
There are no extra hospitals visits.
Side effects
Your doctor will talk to you about the side effects of your chemotherapy treatment.
We have information about of the side effects of chemotherapy for ALL.
We have information about stem cell transplants and bone marrow transplants.
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.
Chief Investigator
Professor Adele Fielding
Supported by
Cancer Research UK
NIHR Clinical Research Network: Cancer
Novartis
Roche
CRUK & UCL Cancer Trials Centre
Chugai Pharma UK Ltd
Biovitrum
Sigma Tau
Baxalta
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
