A trial looking at treatment for babies with acute lymphoblastic leukaemia or mixed type leukaemia (INTERFANT-06, LK 2006 10)

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
Children's cancers
Leukaemia

Status:

Closed

Phase:

Phase 3

This trial is looking at chemotherapy and stem cell transplants for babies with acute lymphoblastic leukaemia (ALL) or mixed type leukaemia. Doctors call leukaemia that is a mixture of types biphenotypic leukaemia.

More about this trial

Doctors in Europe and America have already carried out trials to establish standard treatment for children and babies with acute lymphoblastic leukaemia (ALL). The results show that most babies do well, but the leukaemia comes back in some.

Doctors think that some babies may need more intensive treatment. This trial will compare standard chemotherapy with more intensive chemotherapy for babies who are at a medium or high risk of their leukaemia coming back. It also aims to find out if a stem cell transplant improves treatment for these babies.

Who can enter

Your baby can enter this trial if he or she

  • Has recently been diagnosed with acute lymphoblastic leukaemia (ALL) or biphenotypic leukaemia, including leukaemia in the central nervous system or testicle
  • Is less than 1 year old (up to your child’s first birthday)

Your baby cannot enter this trial if he or she

  • Has a sub type of ALL called mature B cell ALL
  • Has ALL that has come back after treatment (relapsed)
  • Took steroids in the 4 weeks before being diagnosed with leukaemia
  • 1 year old or more

Trial design

This phase 3 trial aims to recruit 445 babies from hospitals in Europe and America. Before treatment begins your baby has central line put in. It makes it easier to give chemotherapy and take blood samples.

First of all, your baby will have treatment with drugs for about 6 weeks. This is called the remission induction phase of treatment. These drugs include steroids and chemotherapy. Your baby has some of these by mouth, by injection into his or her central line, or by injection into spinal fluid Open a glossary item.

Your baby will then be put into 1 of 3 groups depending on the risk of your baby’s leukeamia coming back. These are groups for low, medium and high risk. Your baby’s risk is determined by

  • Their age
  • Their white blood cell count
  • Whether a gene known as MLL is rearranged in the leukaemic cells
  • How well their treatment has worked so far

Low risk group

If your baby is in the low risk group, he or she will have standard treatment. Your baby has 3 different courses of chemotherapy over about 4 months as part of the consolidation phase of treatment. This is followed by maintenance chemotherapy over 2 years.

These courses include a number of different drugs. Your baby has some of these drugs into their central line, into their spine or as tablets. Your baby’s doctor will tell you more about when and how often your baby has these drugs.

Medium risk group

If your baby is in the medium risk group, there are 2 different treatment groups. This part of the trial is randomised. The children taking part are put into the different treatment groups by a computer. Neither you nor your doctor will be able to decide which group your baby is in.

If your baby is in group 1, he or she will have standard treatment, as described in the low risk group above. If your baby is in group 2, he or she will have more intensive treatment. Instead of the first course of consolidation chemotherapy, your baby will have 2 different courses of chemotherapy. Some of the drugs are the same as those in the standard treatment and some are different. The rest of the consolidation and maintenance treatment is very similar to treatment in group 1.

High risk group

If your baby is in the high risk group, there are 2 different treatment groups and it is randomised. Neither you nor your doctor will be able to decide which group your baby is in.

If your baby is in group 3, he or she will have chemotherapy as described in the low risk group. The difference is that, if possible he or she will have a stem cell transplant using their own stem cells (autologous transplant). They have this before or during their 3rd course of consolidation chemotherapy.

If your baby is in group 4, he or she will have more intensive chemotherapy. Instead of the first course of standard consolidation chemotherapy, your baby will have 2 different courses of chemotherapy. If possible, your baby will have a stem cell transplant using their own stem cells (autologous transplant). They have this before or during their 4th course of consolidation chemotherapy. The rest of the consolidation and maintenance treatment is very similar to that of group 3. Some babies who have a relatively high level of minimal residual disease (MRD) but are otherwise classed as 'medium risk' may also have a stem cell transplant.

Hospital visits

Before your baby starts treatment, a doctor will examine them and he or she will have various tests. These include

Your baby will have some of these tests again during and after their treatment.

Your baby’s treatment for their leukaemia will be very intensive, whether they take part in this trial or not. Your baby will stay in hospital to have treatment during the first few months. He or she will then probably be able to have the rest of their treatment as an outpatient.

If your baby has more intensive chemotherapy, they will spend about 1 month longer in hospital.

After treatment has finished, your baby will have regular follow up appointments with the consultant. These will be arranged individually.

Side effects

All the drugs used in this trial have side effects. The most common side effects include

Those babies who have more intensive treatment have a greater risk of infection than those babies having standard treatment. All children will be monitored very closely for side effects and your baby will have treatment to help with them if necessary.

There is more information about the individual drugs used in this trial on CancerHelp UK. These drugs include vincristine, cytarabine, daunorubicin, asparaginase, methotrexate, cyclophosphamide, mercaptopurine, tioguanine, etoposide and mitoxantrone.

There is more information about the side effects of a stem cell transplant on CancerHelp UK.

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 P. Ancliff

Supported by

Cancer Research UK
Cancer Research UK Children's Cancer Trials Team University of Birmingham
Children's Cancer and Leukaemia Group (CCLG)
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer

Other information

This is Cancer Research UK trial number CRUK/08/030.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

3729

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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