Trial Information

A Randomized Study Comparing Chemotherapy Followed by G-CSF Alone Versus G-CSF Plus GM-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas

Granulocyte-colony stimulating factor (G-CSF) and granulocyte macrophage-colony stimulating
factor (GM-CSF) are synthetic (man-made) versions of substances naturally produced in your
body. These substances, called colony stimulating factors, help the bone marrow to make new
white blood cells. When certain cancer medicines fight your cancer cells, they also affect
those white blood cells that fight infection. To help decrease the risk of infections when
these cancer medicines are used, colony stimulating factors may be given. Colony stimulating
factors are also used to help the bone marrow recover after bone marrow transplantation and
stem cell transplantation. They are also used to increase the stem cell count in the blood
so that adequate number of stem cells can be collected for purposes of transplantation.

Before the study begins, you will have a complete physical exam and have blood (around 1-2
tablespoons) and urine collected for routine tests. You will have x-rays and CT scans to
check on the status of the disease. A sample of bone marrow will be collected for tests.
To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic
and a small amount of bone marrow is withdrawn through a large needle. Your heart and lung
function will be evaluated. You will have an electrocardiogram (ECG - a test that measures
the electrical activity of the heart) and either a echocardiogram or a multigated
acquisition scan (MUGA) (these are tests that measure heart functions). You will also have
lung function tests. Women who are able to have children must have a negative blood or
urine pregnancy test.

You will have a plastic tube (central venous catheter - CVL) inserted under your collarbone.
The CVL will be left in place for the duration of the treatment. The catheter will be used
to deliver most of the drugs and for the collection and transfusion of the stem cells. When
possible, all drugs that need to be given by vein will be given using the catheter.

All treatment will be given at M. D. Anderson. First, you will be given chemotherapy to
increase the number of stem cells in your blood stream. This chemotherapy will include the
drugs ifosfamide, etoposide, and rituximab. You will receive a higher dose of rituximab than
is standard of care. The drug ifosfamide will be started on Day 2 and will be given as a
continuous injection into a vein over 72 hours. The drug etoposide will also be started on
Day 2 and will be given by vein over 2 hours every 12 hours. Rituximab will be given by vein
over 4-6 hours on Days 1 and 8. To help decrease the risk of developing side effects caused
by the chemotherapy, you will be given fluids by vein and a drug called mesna. Mesna will
be given by vein over 24 hours after treatment with ifosfamide is finished. You will have
to stay in the hospital for 4-6 days for this part of the treatment.

You will be randomly assigned (as in the toss of a coin) to one of two treatment groups.
Participants in one group will receive G-CSF and GM-CSF. Participants in the other group
will receive G-CSF alone.

After completion of chemotherapy, you will get GM-CSF and G-CSF or just G-CSF injections
(given under the skin) twice a day. These drugs are given to help increase the number of
white blood cells and will continue to be given until an adequate number of stem cells have
been collected. During this time, you will have blood collected for tests (around 1
tablespoon) at least 3 times a week. If your doctor feels it is necessary, you may have
blood collected more often.

Blood stem cells will be collected when your blood counts have returned to normal (about
10-16 days after the chemotherapy). The process of stem cell collection takes about 4 hours.
It may take 1-6 sessions to collect the number of stem cells needed for the transplant. The
process of stem cell collection is called apheresis. A machine is attached to the catheter
under the collar bone and blood is withdrawn. The blood then flows through the machine,
which removes stem cells from the blood. The blood is then returned back to you through the
catheter. The stem cells are then frozen and stored. These stem cells will be given back to
you after the next phase of treatment to help your blood counts recover after high dose
chemotherapy. After enough stem cells have been collected, you will be admitted to the
hospital for high dose chemotherapy.

You will have check-up visits at various times over the next year as part of your standard
evaluation after transplantation to check on the status of the disease.

This is an investigational study. All of the drugs used in this study are FDA approved and
are commercially available. Up to 100 patients will take part in this study. All will be
enrolled at M. D. Anderson.