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About the 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.

A research study — introduction

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. (For a definition of a Phase III randomized trial, see What Is a Clinical Trial?) This page gives a short summary of the trial. If you are asked to take part in the trial, your donor center coordinator will give you complete information before you decide if you want to take part.

Who can be in the study?

Donors who join this study project must:

Be matched with a recipient
Give informed consent before enrollment in the study — informed consent means you have been told about and understand the possible risks and benefits before agreeing to be in the study
Be medically eligible to donate either marrow or PBSCs
Agree to make the type of donation (marrow or PBSC) randomly assigned by a computer

How many people will join?

A total of 550 patient and donor pairs will enroll in the study over three years. More than 50 donor centers will participate in the study and more than 40 transplant 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 also help donor center medical directors learn more about the side effects of each donation type (marrow and PBSC) for future donors. The study will look at:

Patients' survival rates after transplant.
How well patients recover after transplant.
Donors’ and patients' quality of life. The study will interview donors and patients to measure how they feel after donation or transplant and how well they can do daily tasks and activities that are important to them.
The differences in the PBSC donors’ and marrow donors’ physical side effects and how the donation experience affects their daily life.

What can I expect?

Source of cells for the transplant

You will donate either marrow or PBSCs. Half of the donors in the clinical trial will donate marrow. The other half will donate PBSCs. The PBSC and marrow donation processes are the same for donors who participate in the study as for donors who do not participate in the study. For information about the donation processes, see the Donation FAQs.

A randomized study

If you are in the study, neither you nor your donor center chooses whether you will donate 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 a blood test at 1 month, 6 months and annually for 3 years after donation.
You will also be asked to give 2 blood samples for research before your donation.
All other blood and medical tests are the same tests performed on all NMDP donors, whether or not they are participating in the study. Your donor center coordinator can provide you with more information about standard NMDP donor testing.

Interviews

If you can read and speak English, have access to a phone and are able to complete a survey, you will be interviewed over the phone about your physical and emotional health for the quality of life part of the study. The interviews take place:

Before donation
On day 4 of filgrastim injections for PBSC donors
Two days after your donation
Every week after your donation until you are fully well again for 4 weeks in a row
Six months after your donation
One year after your donation

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 donors.
Marrow or PBSC donations have risks. Talk with your donor center coordinator about what your risks might be.

Donating without joining the study

If you don't want to be in the study, you may still be able to donate marrow or PBSC for the patient who matches you.

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 3 years from your donation. You may also be asked to participate in standard NMDP follow-up assessments (not a part of the study) after 3 years.
You can decide to leave the study at any time.

Will it cost me money to be in this study?

There is no cost to you for the check ups, donating the cells or the quality of life surveys.

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 donor and transplant centers. Many centers will participate in the study so that many donors and patients can be included.

Where can I get more information?

Talk to your donor center coordinator and medical director.
Contact the NMDP Donor Medical Services at 1 (888) 510-1808 or medicalservices@nmdp.org.
Contact the NMDP Donor Advocacy Program: 1 (800) 627-7692 or advocate@nmdp.org.