IRB Number:

2158-03

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

This research study will compare the outcomes of study participants who have had peripheral blood stem cell transplantation from unrelated donors with those who have had bone marrow transplant from unrelated donors for the treatment of serious hematological malignancies.

Two types of stem cell transplantation have been used to treat patients with certain types of serious diseases. Stem cells can be obtained from bone marrow or from circulating blood (peripheral blood stem cells). Participants may be treated with a transplant of either bone marrow or peripheral blood stem cells (PBSC) from unrelated donors.

Both of these types of transplant have been successful for the treatment of leukemia and myelodysplasia. The goal of this research study is to see if there are better results using a bone marrow transplant or a PBSC transplant from unrelated donors.

Who is Eligible to Participate in the Study?

Men or women between the ages of 18 and 66 who are undergoing unrelated blood stem cell transplantation for the first time for the treatment of their hematological malignancy may be eligible for this research study. Additional eligibility criteria will be gathered and evaluated by the transplant physician to determine if an individual is eligible to take part.

Maximum Age:

66

What is Involved With this Study?

• Those individuals who wish to take part in this study must sign a consent form. After a suitable donor has been found, the donor must also sign a consent form to take part.


• If the donor does not wish to take part, the transplant will not occur as a part of the study but will continue to proceed with the transplant process.


• If both the donor and participant agree to take part, the participant will be randomly assigned (as in the flip of a coin) to determine if the transplant will use bone marrow or peripheral blood stem cells from the donor. The transplant will then follow our program's routine procedures.


• Participant progress will be followed and information will be gathered for the study from the patient's medical history.


• Extra blood may be collected for study tests if the participant agrees.


• Participants will also be asked to complete quality of life questionnaires at various time periods during the study.

How long will the Study run?

Participants taking part in this research study may be followed for up to 5 years.

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information or to participate in this research study, please contact Jennie Wilson at (507) 284-6814 or Barb Trotzat (507) 288-2224.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 07/03/2008