Trial Information

Summary: BMT CTN 0201: A Phase III Randomized, Multicenter Trial Comparing G-CSF Mobilized Peripheral Blood Stem Cell with Marrow Transplantation from HLA Compatible Unrelated Donors

For the Donor:

You have been asked to participate in this research study because you have been matched to a potential recipient for your donated stem cells (immature cells that can become blood cells) and the recipient has agreed to be in this study.  These stem cells could be taken from either your bone marrow or peripheral blood (circulating blood), and participation in the study means that you are willing to undergo either type of stem cell collection.  The purpose of this study is to compare unrelated donor transplants of stem cells (immature cells that can become blood cells) collected from the donor’s blood stream to cells collected from the donor’s bone marrow in terms of the number of recipients that survive after two years.  An additional purpose is to compare the experience of donors who donate cells from the blood stream or the bone marrow in terms of 1) physical side effects, 2) the time it takes to recover, and 3) quality of life, such as emotional experience and effects on daily activities.  Laboratory tests will also be done to study the relationship between characteristics of the cells and the outcome of transplants.  Your participation in this study is expected to last up to several months from the time you sign the consent from until the time your bone marrow or stem cells are collected and then approximately 3 years for follow-up.

For the recipient:

You have/your child has been asked to participate in this research study because you have/your child has one of the following diseases: acute myelogenous leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myelogenous leukemia (CML), myelodysplastic syndrome (MDS) or a myeloproliferative disease.  You/your child are planning to undergo a transplant of stem cells (immature cells that can become blood cells) from an unrelated donor.  These stem cells could be taken from either the donor’s bone marrow or peripheral blood (circulating blood), and participation in the study means that you are willing to accept either type of transplant.  The purpose of this study is to compare bone marrow transplant (BMT) to peripheral blood stem cell transplant (PBSCT) in terms of the number of recipients that survive after two years, how long it takes the blood cells and immune system to recover, side effects such as acute (short-term) and chronic (long-term) graft-versus-host disease (GVHD, a condition where the donor’s cells have an immune response against the recipient’s body), how long recipients must continue taking immunosuppressive medicines (given to prevent GVHD), the quality of life of donors, and the quality of life of recipients.  Laboratory tests will also be done to study the relationship between characteristics of the cells and the outcome of transplants. Your/your child’s participation in this study is expected to last approximately 3 to 6 months for treatment and approximately 5 years for follow-up.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

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Trial listings updated: September 2, 2008 at 1:44:21 PM