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PBSC vs. Marrow Clinical Trial

Unrelated donor bone marrow transplants have been used to treat patients with blood disorders such as leukemia and myelodysplasia for many years. A newer treatment is transplants using cells collected from the blood stream, which are often called peripheral blood (circulating) cell (PBSC) transplants. Both marrow and PBSC transplants have been used with success.

Doctors want to know if the different sources of blood-forming cells give different transplant benefits. So far, research has not shown if one is better than the other. The National Marrow Donor Program (NMDP) and its partners in the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) are sponsoring a research study to compare the two types of transplants to see if one works better than the other. The study may also find that patients have similar results with either type of transplant. At the same time, the study will look at the differences in donating for marrow and PBSC donors.

The clinical trial comparing PBSC to marrow from unrelated donors is a Phase III, randomized, multi-center trial. This page gives a short summary of the trial. If you are able to take part in the trial, your doctor will give you complete information before you decide if you want to take part.

Who can be in the study?

Patients who join this study project must:

Be under the age of 67
Have leukemia, myelodysplastic syndrome (MDS) or myeloproliferative disease
Be healthy enough to have a transplant from an unrelated donor
Have a matching unrelated donor found through the NMDP who also agrees to be in the study
Be treated at a participating NMDP transplant center in the United States

How many people will join?

A total of 550 patient and donor pairs will enroll in the study over three years. More than 38 medical centers will treat patients in this study.

Why is this study important?

Information from this study will help doctors and future transplant patients make better treatment choices. The study will look at:

Patients' survival rates after transplant.
How well patients recover after transplant. Some of the results doctors will watch include patients' blood counts, infection levels, whether they get graft-versus-host disease, and whether their disease returns.
Patients' quality of life. The study will interview patients to measure how they feel after transplant and how well they can do daily tasks and activities that are important to them.
The differences in the PBSC and marrow donor's physical side effects and how the donation experience affects their daily life.

What can I expect?

Source of cells for the transplant

You will receive a transplant using either marrow or PBSC. Half of the patients in the clinical trial will receive a marrow transplant from an unrelated donor. The other half will receive a PBSC transplant from an unrelated donor.

A randomized study

If you are in the study, neither you nor your doctor chooses whether you will receive marrow or PBSC. You will be assigned to one group or the other at random, much like the toss of a coin. The best way to have reliable research results is to conduct a randomized study.

Blood and medical tests

For the study, you will have blood and medical tests on a scheduled basis.
You will also be asked to give blood samples for research. You can decide not to give these blood samples and still be in the study.

Interviews

If you are 16 years of age or older, you will be interviewed over the phone about your physical and emotional health before the transplant, and 6 months, 1 year, 2 years and 5 years after your transplant. You can choose to skip any interview questions you wish.

Benefits and risks

You will not benefit from being in this study. Your taking part may help future transplant patients.
All marrow or PBSC transplants and the treatment that goes with them have risks. Talk with your doctor about what your risks might be.

Getting a transplant without joining the study

You do not need to join the study to get a marrow or PBSC transplant.

If you don't want to be in the study, you may still be able to get a transplant from a donor who matches you.
If a matching donor does not want to be in the study but is willing to donate, you may still be able to get a transplant from that donor without being in the study.

How long does the study last?

Being in the study is your choice. If you decide to be in the study, you will be asked to sign a consent form. If you decide to be in the study:

You will be in the study for 5 years from the start of your transplant.
The researchers may stop your participation in the study at any time if they are worried about your safety.
You can decide to leave the study at any time.

Who pays for my treatment in this study?

You will not be charged for research tests. You and/or your insurance company will pay all the bills for your medical treatment. This is the treatment you would receive if you had a transplant without joining the study. You can ask a financial counselor at your transplant center for help understanding your costs and insurance coverage for your transplant.

Who is running the study?

The study is directed by the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) and the National Marrow Donor Program (NMDP).
The study is paid for by the National Institutes of Health (a federal agency of the Department of Health and Human Services that focuses on health research) and the NMDP.
The study will be done at many different medical centers in the United States. Many centers will participate in the study so that many patients can be included.

Where can I get more information?

Talk to your transplant doctor.
To contact the National Marrow Donor Program Office of Patient Advocacy: Inside the United States, call 1 (888) 999-6743. This call is toll-free in the United States. Outside the United States, call 1 (612) 627-8140. This call may have long-distance or international charges. NMDP OPA staff are available Monday - Friday, 8 a.m. to 5 p.m. Central time. You can also send an e-mail message to patientinfo@nmdp.org.
See a summary of the study, the study protocol, consent forms and other information at the BMT CTN Web site: http://spitfire.emmes.com/
study/bmt/protocol/0201__protocol/0201__protocol.html.