Clinical Trials

Comparison of Peripheral Blood Stem Cell Transplantation With Bone Marrow Transplantation for the Treatment of Serious Hematological Malignancies

Location:

Trial status:

Closed

Why is this study being done?

This study is a randomized, open-label, multicenter, prospective, comparative trial of granulocyte colony stimulating factor (G-CSF) mobilized peripheral blood stem cells verses marrow from unrelated donors for transplantation in patients with hematologic malignancies. The study will be comparing two-year survival probabilities between process has many steps after a matched donor is found. The donor also needs to give permission to join this study. Participants will be randomized to either peripheral blood stem cells (PBSC) or bone marrow. The kind of transplant the participant receives is random. Neither the participant nor the doctor may choose the type of transplant.

Participants will receive vaccinations for diphtheria, tetanus, hepatitis B and pneumococcus. Blood samples will be drawn as part of a participant's normal care. Blood samples will also be collected to see if infection fighting cells are working. These samples will be collected at 12 weeks, one year and then yearly until three years post transplant. Information will be collected from the participant's medical history. Participants will also have phone interviews conducted and questions will be asked about their physical and emotional health. Participants taking part in this study may be followed for up to 5 years.

Who is eligible to participate?

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

What is involved?

• 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 is the study?

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

Last updated: 06/02/2010

NCT ID:

NCT00275678