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

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 .

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.