Trial Information

Summary: A Phase I Study of Clofarabine Plus High Dose Melphalan as a Conditioning Regimen for Allogeneic Transplantation

You/your child have been asked to participate in this research study because you/your child are being considered for an allogeneic transplant, have a matched sibling (brother or sister) who is willing to donate peripheral blood stem cells (immature cells that can become blood cells) or bone marrow, and have one of the following medical conditions:

·         Acute Myeloid Leukemia (AML) that has relapsed (returned after initially responding to chemotherapy);

·         Acute Myeloid Leukemia in greater than second remission;

·         Acute Lymphoblastic Leukemia (ALL);

·         Myelodysplasia (MDS, “pre-leukemia”)

The purpose of this study is to determine the highest dose of clofarabine that can be combined with high-dose melphalan as a preparative regimen for transplantation.  Another purpose of this study is to determine the highest dose of clofarabine that can be given without causing unmanageable side effects and to evaluate the side effects of this regimen.  Blood specimens will be collected for laboratory studies to evaluate this regimen in terms of engraftment, reconstitution (return to its previous state) of the immune system, and treatment outcome. You/your child participation in this study is expected to last about two months for treatment.  After treatment on this study is over, you/your child’s medical condition will be followed indefinitely.

Patient Inclusion/Exclusion Criteria:

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

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Trial listings updated: December 1, 2008 at 3:15:43 PM