Trial Information

Feasibility Study of the Assessment of Symptom-Related Cytokines in AML/MDS Patients Undergoing Allogeneic Blood or Marrow Transplantation

One of the ways to learn about the symptoms of blood and/or bone marrow transplantation is
by looking at how certain proteins called cytokines (found in the blood) change during
treatment.

Before the transplantation, you will be asked to complete several questionnaires during a
visit to the bone marrow clinic at M. D. Anderson. These questionnaires measure physical and
emotional symptoms. The questionnaires should take about 30 minutes to complete. During
this visit, the research nurse will teach you how to use the telephone system for measuring
symptoms. You will tell the system the most convenient times for the telephone calls. This
first assessment (questionnaires and learning the telephone system) should take about 90
minutes.

On the day you are admitted, or up to 10 days before your admission for your transplant, you
will have a sample of blood drawn (around 2½ tablespoons) . The sample of blood will be
used to measure levels of cytokines in your blood before the transplant procedure. You will
also have blood drawn about three days postadmission, on the day of transplant, 1 day after
transplant, 3 days, 8 days, 15 days, 22 days, and 29 days posttransplant. One blood sample
will be taken between 50 - 60 days posttransplant and one sample between 80 - 100 days after
transplant. If you develop Graft Versus Host Disease (GVHD), cytokine samples will be
assessed within 24 hours of GVHD diagnosis, then 3 days, 5 days, 10 days and 15 days after
GVHD diagnosis. Around 2½ tablespoons of blood will be collected each time. These samples
of blood will be used to measure the levels of cytokines in your blood after the transplant
procedure. These cytokines may be related to symptoms experienced after the transplant
procedure.

The research nurse will come to your room and collect information about your symptoms 2
times a week while you are in the hospital or until you are able to use the IVR system.
Once you return to your home, the automated telephone system will call you once a week to
ask you to rate your symptoms and how much the symptoms interfere in your daily life. It
should take around 5 minutes to complete each automated phone symptom assessment.

The information collected by these calls is only being used for this research study. At the
beginning of each IVR telephone call, you will be reminded to report any symptom/s you are
concerned about to your treating physician.

This is an investigational study. Up to 40 participants will take part in this study. All
will be enrolled at M. D. Anderson.