This research study will investigate the use of anti-cancer medications and radiation therapy, followed by a stem cell transplant from a “matched unrelated donor”, to treat the conditions listed above. Researchers will study the benefits and side effects with stem cell transplantation from an unrelated donor.

The best type of donor for a stem cell transplant is a brother or sister who is a “match” for the patient’s immune type (HLA type). Many patients do not have a genetically matched donor. In this study the participant will receive stem cells form a closely matched, unrelated volunteer donor. These stem cells will not be as closely matched as those from a brother or sister. As a result, there is a higher chance of problems related to the stem cell transplant. Problems include failure of the donor cells to grow (graft failure), and a condition called graft-verses-host disease (GVHD). GVHD occurs when the donor cells (the graft) recognizes that the body tissues of the patient (the host) are different. Severe graft verses host disease can be life threatening.

Condition	Intervention	Phase
Acute Lymphoblastic Leukemias Acute Myelocytic Leukemia Chronic Myeloid Leukemia Juvenile Myelomonocytic Leukemia Myelodysplastic Syndrome Hemoglobinuria, Paroxysmal Non-Hodgkin Lymphoma	Procedure: Stem Cell Transplantation  Drug: Cyclophosphamide, Mesna, Thiotepa, Methylprednisolone	Phase III

Further Study Details: 

Primary Outcomes: To estimate the occurrence of acute graft vs. host disease in patients who have received an unmanipulated hematopoietic stem cell transplant from a matched unrelated donor; To estimate disease free survival and relapse rate in patients receiving this type transplant; To estimate the rates of chronic graft verses host disease and graft failure in these transplant patients; To monitor the growth of donor stem cell and other blood cells after transplant; To study how medication given before transplant is used by the body
Expected Total Enrollment:  207

Ages Eligible for Study:  2 Years   -   21 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Patient lacks an HLA-identical sibling Greater than or equal to 24 months old and less than or equal to 21 years old High-risk hematologic malignancy Adequate cardiac, renal, hepatic and respiratory function Adequate performance status No previous allograft (bone marrow or stem cell transplant from another person) Unrelated donor match available

Tennessee
      St. Jude Children''''s Research Hospital, Memphis,  Tennessee,  38105,  United States

Study chairs or principal investigators

Edwin M. Horwitz, M.D.,  Principal Investigator,  St. Jude Children''''s Research Hospital   

Study ID Numbers:  MUDSCT
Last Updated:  September 12, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00152139
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13