Trial Information

Summary: BMT CTN 0303: A Single Arm, Multicenter Phase II Trial of Transplants of HLA-Matched, CD34+Enriched, T Cell Depleted Peripheral Blood Stem Cells Isolated by The CliniMACS System in The Treatment of Patients With AML in First or Second Morphologic Complete Remission

RECIPIENT

You have been asked to participate in this research study because you have acute myelogenous leukemia (AML) and plan to be treated with an allogeneic (from a donor who is a tissue match of the recipient) stem cell (immature cells that can develop into different types of blood cells) transplant.  The purpose of this study is to determine whether AML can be effectively treated with radiation therapy and chemotherapy followed by an allogeneic stem cell transplant from which T Cells (cells associated with immunity that can cause a serious complication called graft-versus-host disease (GVHD)) have been removed.  Another purpose is to evaluate the frequency and severity of GVHD that occurs with this treatment.  Your participation in this study is expected to last approximately 3 to 6 months for treatment and up to two years for follow-up.

DONOR

You have/your child has been asked to participate in this research study because your/your child’s family member has acute myelogenous leukemia (AML) and plans to be treated with an allogeneic (from a donor who is a tissue match of the recipient) stem cell (immature cells that can develop into different types of blood cells) transplant.  The purpose of this study is to determine whether AML can be effectively treated with radiation therapy and chemotherapy followed by an allogeneic stem cell transplant from which T Cells (cells associated with immunity that can cause a serious complication called graft-versus-host disease) have been removed.  Another purpose is to evaluate the frequency and severity of graft-versus-host disease (GVHD) that occurs with this treatment.  Your/your child’s participation in this study is expected to last for several months from the time you/your child sign(s) the consent until approximately one month after stem cell collection.  You/your child will take G-CSF for 5 to 7 days, and the stem cells will be collected during that period of time.

Patient Inclusion/Exclusion Criteria:

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

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Trial listings updated: October 6, 2008 at 2:28:25 PM