Safety and Efficacy of Unrelated Cord Blood Transplantation for Adult Patients With Hematologic Malignancies

Phase 1/2 Study of Cord Blood Transplantation From Unrelated Donor for Adult Patients With Hematologic Malignancies Using Myeloablative Conditioning Regimen

The primary purpose of this study is to evaluate the safety and efficacy of cord blood transplantation for adult patients with hematologic malignancies including refractory acute leukemia. The transplant procedure was determined in detail according to the previously published report showing a high survival, so that the investigators could expect a similar result.

Although cord blood is considered as an alternative donor source for allogeneic hematopoietic stem cell transplantation, its procedure has yet to be standardized. Recently, a single institute result of cord blood transplantation for adult patients with hematologic malignancies have been reported by Takahashi et al (Blood 2004:104;3813-3820), in which the survival was significantly better than that of bone marrow transplantation from unrelated donor. The purpose of this study was to reevaluate the safety and efficacy of cord blood transplantation for adult patients with hematologic malignancies using the same transplant procedures in a multi-institutional setting.

Inclusion Criteria:

• Clinical diagnosis of acute leukemia, chronic myelogenous leukemia, and myelodysplastic syndrome
• Lack of HLA-identical or 1 locus mismatched related donor
• Age over 20, and under 55
• Performance status 0 or 1
• No moderate or sever organ dysfunction (liver, kidney, heart, lungs)
• No anti-HLA antibody
• Informed consent was obtained

Exclusion Criteria:

• Uncontrollable diabetes
• Uncontrollable hypertension
• Active infection
• TPHA, HBs-Ag, HCV-Ab positive
• HTLV-I, HIV positive