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Title:
A Multi-Center, Phase III, Randomized Trial of Reduced Intensity(RIC) Conditioning and Transplantation of Double Unrelated Umbilical Cord Blood (dUCB) versus HLA-Haploidentical Related Bone Marrow (Haplo) for Patients with Hematologic Malignancies (BMT CTN 1101)
Protocol Number:
J11159
Phase:
Phase III
Physician:
Ephraim Fuchs
Purpose:
This research is being done because we want to learn more about reduced-intensity transplants that use a mismatched donor. In this study we will use either cord blood from an unrelated donor or bone marrow from a family member, and then compare the transplant results. These results will help us understand if one kind of mismatched donor is better or if there is no difference at all.
Eligibility:
This study is for patients' with a cancer of the blood or lymph glands and where stem cell transplant is a treatment option and you do not have a completely matched donor available in your family. You also do not have a matched donor outside of your family who can donate when you need them to. However, you do have two other donor choices available for a transplant: (1) partially matched units of unrelated cord blood, and (2) a family donor who is a partial match.
Treatment:
Conditioning Regimen before Transplant (chemotherapy and radiation): Bone Marrow: If you are receiving bone marrow, you will be treated with a type of chemotherapy called fludarabine (also called Fludara®), which is given daily intravenously through your catheter daily for 5 days. You also will be given cyclophosphamide (also called Cytoxan®) intravenously on your first and second day along with fludarabine. Hydration with normal saline prior to cyclophosphamide may be given according to institutional standards. Cord Blood: If you are receiving cord blood, you will be treated with a type of chemotherapy called fludarabine (also called Fludara®), which is given daily intravenously through your catheter daily for 5 days. You also will be given cyclophosphamide (also called Cytoxan®) intravenously on your first day along with fludarabine. Hydration with normal saline prior to cyclophosphamide may be given according to institutional standards. The day after the chemotherapy is finished, you will receive radiation to your whole body (Total Body Irradiation) in a single dose. Reinfusion of Stem Cells (Transplant) On your transplant day, Day 0, if you receive cord blood, it will be given to you through your catheter like a blood transfusion.
Population:
Adult
Last Update
04/20/2014 04:02 AM
 

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