A trial looking at chemotherapy for Waldenstrom's macroglobulinaemia or lymphoma of the spleen (WM1)

Please note this trial is no longer recruiting patients.

This trial is comparing chlorambucil with fludarabine chemotherapy for Waldenstrom's macroglobulinaemia or lymphoma of the spleen.

Doctors treat Waldenstrom’s macroglobulinaemia or lymphoma of the spleen with chemotherapy. Fludarabine and chlorambucil are drugs that are commonly used. Doctors know that both drugs are effective treatments but want to find out which drug works the best as they are not sure.

This trial is comparing these drugs that are being given every 4 weeks, to see which might be better. And to find out more about the side effects.

Recruitment

Start 01/09/2000

End 31/12/2009

Phase

Phase 3

Who can enter

You can enter this trial if you

Have Waldenstrom’s macroglobulinaemia or lymphoma of the spleen that needs chemotherapy treatment
Are well enough to have chemotherapy (performance status 0 or 1, 2)
Have satisfactory blood test results
Are at least 18 years old
Are willing to use reliable contraception while you are taking part in the trial if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

Have any other type of cancer at the moment
Have any other serious medical condition
Have liver or kidney problems
Are hepatitis C positive or have AIDS
Have an infection and are taking antibiotics
Are pregnant or breastfeeding

Trial design

This is a phase 3. It aims to recruit about 400 people. The trial is randomised. If you take part you will be put into one of 2 different treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1, you will have chlorambucil. You have this drug as a tablet, to swallow which you take for 10 days in each cycle of chemotherapy. The cycle is repeated every 28 days. You will have at least 3 cycles of this treatment. If your doctor thinks you are responding well to the treatment then you may have up to 12 cycles in total. So your treatment will last between 3 and 12 months.

Group 2 will have fludarabine. You will have this as a tablet to take daily for 5 days in each cycle of chemotherapy. The cycle is repeated every 28 days. Your doctor may want you to have fludarabine into your vein through a drip instead of taking a tablet. If so, then you will have this drip every day for 5 days each cycle of chemotherapy. You will have at least 3 cycles of fludarabine chemotherapy and a maximum of 6 cycles. So your treatment will last for between 3 and 6 months.

Hospital visits

You will need to go to the hospital to have some tests before you can take part in this trial. These tests include

A bone marrow biopsy
Blood tests
Physical examination

You may also have a CT scan.

You will have blood tests and check ups throughout your treatment. Whichever group you are in, you will need to come to the hospital every four weeks to have blood tests and pick up your treatment. You will probably spend at least half a day at the hospital each time. If you are having fludarabine through a drip, you will need to come to the hospital daily for 5 consecutive days out of every 28 days.

After your treatment has finished you will see your doctor regularly in the outpatients clinic. For the first year after completing treatment you will be seen every 3 months and thereafter every 6 months. Your doctor will ask how you are, examine you and check your blood. He may arrange for you to have other tests, such as blood tests or a bone marrow biopsy.

You may also be asked to fill out a questionnaire during your treatment. This will ask you how you have been feeling. It is called a 'quality of life' study.