Trial Information

Use of Umbilical Cord Blood Cell in the Preparative Regimen of Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Cord blood is a source of blood-forming cells that can be used for transplantation. Cord
blood cells are taken from the umbilical cords of women who have given birth, and who have
volunteered to donate their umbilical cord. Researchers hope that using cord blood before a
stem cell transplant will help to reduce the risk of graft-versus-host-disease (GVHD). GVHD
occurs when donor cells attack the cells of the person receiving the transplant.

If you are found to be eligible to take part in this study, you will receive chemotherapy
for 5 days. You will receive fludarabine over about 30 minutes through a needle in your
vein on Days 1-4. You will receive melphalan through a needle in your vein over about 30
minutes on Day 5.

On Day 7, you will receive the cord blood cells through a needle in your vein over about 30
minutes.

On Day 12, you will receive blood stem cells through a needle in your vein over 30-60
minutes. The stem cells you receive will be from a stem cell donor whose human leukocyte
antigen (HLA- proteins on cells) type matches yours.

If appropriate for the disease, you will also receive rituximab about once weekly for 4
weeks, beginning on the day you receive melphalan. Rituximab is given though a needle in
your vein over 2-3 hours.

You will receive the drugs tacrolimus and methotrexate to lower the risk of GVHD.
Tacrolimus will be given through a needle in your vein non-stop for 2 weeks, starting 12
hours after the stem cell transplant. After the first 2 weeks, you will continue to receive
tacrolimus by mouth, for at least 3 months. You will receive methotrexate though a needle
in your vein over 30 minutes, starting 1 day after the stem cell transplant, for a total of
3 doses over the first 6 days after the stem cell transplant.

You will receive the G-CSF (granulocyte-colony stimulating factor) to help you blood cell
counts recover. G-CSF will be given as an injection under the skin, beginning 1 week after
the stem cell transplant. You will continue to receive G-CSF once a day until your blood
cell counts reach a certain high enough level.

You will need to stay in the hospital for about 4 weeks beginning on Day 1. While you are in
the hospital, blood (about 2 teaspoons) will be drawn every day for routine tests.

After you leave the hospital, you will return to the hospital for visits 2-3 times a week
for at least 100 days after the transplant. During these visits, you will have a physical
exam and blood (about 2 teaspoons) will be drawn for routine tests.

You will be asked to come back to the clinic for follow-up visits at 3, 6, 9 and 12 months
after your transplant for routine safety testing. This will include a physical exam, a bone
marrow biopsy, and blood (about 2 teaspoons) will be drawn for routine testing.

You will be considered off-study after the 12-month follow-up visit.

This is an investigational study. The stem cell transplant, the umbilical cord transplant,
and all drugs used on this study are FDA approved. The use of umbilical cord blood and stem
cells together is investigational. Up to 30 patients will take part in this study. All will
be enrolled at M. D. Anderson.