A trial looking at treatment for children and young people with anaplastic large cell lymphoma (ALCL99, NHL 2000 06)

Cancer type:

Blood cancers
Children's cancers
High grade lymphoma
Lymphoma
Non-Hodgkin lymphoma

Status:

Results

Phase:

Phase 3

This trial looked at chemotherapy treatment for children with anaplastic large cell lymphoma (ALCL). This trial was for children and young people up to and including the age of 21.

ALCL is a rare type of non Hodgkin lymphoma (NHL). Doctors usually treat ALCL with a combination of several chemotherapy drugs. One of the drugs they often use is called methotrexate.

In this trial, some children and young people had a low dose of methotrexate slowly through a drip into a vein, and also had some of the drug given into the fluid around their spinal cord (intrathecal injection Open a glossary item). Others had a higher dose methotrexate given over a shorter period of time, but without having the intrathecal injection.

Another drug that can be part of the treatment plan for ALCL is vinblastine.

The aims of this trial were to find out

  • If the dose of methotrexate and the way it was given affected the outcome of treatment
  • Whether adding the chemotherapy drug vinblastine to the treatment plan helped to stop ALCL coming back in children and young people who were considered to be at high risk of relapse

Summary of results

The trial team found that the dose of methotrexate and the way it is given didn’t affect the length of time that children and young people lived after treatment.

They also found that adding vinblastine did help to stop ALCL coming back in the 1st year, but after 2 years this effect was lost.

This was an international randomised trial. The children and young people taking part were put into treatment groups at random. Neither they nor their doctor could decide which group they were in.

  • 175 had low dose methotrexate followed by the intrathecal injection
  • 177 had the higher high dose of methotrexate without the intrathecal injection

The trial team looked at the number of children and young people who were still alive after 2 years. They found this was more than 9 out of 10 people in both groups.

But the side effects were worse in those having the low dose and intrathecal injection. So the researchers concluded it was better to give the higher dose of methotrexate without the injection into the spine.

To look at the effect of vinblastine, 217 children and young people who had ALCL considered to be at high risk of coming back were also randomised into 2 other treatment groups. Both groups had chemotherapy. One group had vinblastine as part of this treatment, the other group didn’t.

The trial team looked at the number of children and young people who were living without any signs of their lymphoma coming back 1 year after treatment and again after 2 years.

At 1 year after treatment, they found it was

  • More than 7 out of 10 (74%) who didn’t have vinblastine
  • More than 9 out of 10 (91%) who did have vinblastine

But 2 years after treatment, there wasn’t any statistically significant Open a glossary item difference in the number of people living without any sign of lymphoma. This means the difference between the groups was small and could have happened by chance. So the trial team concluded that adding vinblastine didn’t make any difference to the long term outcome.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.

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 Denise Williams

Supported by

Cancer Research UK Children's Cancer Trials Team
University of Birmingham
Children's Cancer and Leukaemia Group (CCLG)
National Institute for Health Research Cancer Research Network (NCRN)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 236

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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