Phase II Study of Myeloablative Double Unit Umbilical Cord Blood Transplantation in Adult Patients

Prospective Multicenter Phase II Study of Myeloablative Double Unit Umbilical Cord Blood Transplantation in Adult Patients With Hematologic Malignancies

This study aimed to evaluate the efficacy and safety of myeloablative double unit umbilical cord blood transplantation (dUCBT) in adult patients with hematologic malignancies. Two myeloablative conditioning regimens will be used in this study: (1) total body irradation (TBI), cyclophosphamide, and cytarabine, or (2) thiotepa, busulfan, and fludarabine.

Inclusion Criteria:

• Patients with hematologic malignancies requiring hematopoietic stem cell transplantation: (1) high risk acute myeloid leukemia in remission, (2) high risk acute lymphoblastic leukemia in remission, or (3) IPSS intermediate-2, high, or transfusion-dependent myelodysplastic syndrome
• Patients who have suitable cord blood units for dUCBT
• Patients with ECOG performance status 0-1
• Patients with adequate organ function: lung, kidney, liver, heart, etc.
• Informed consent

Exclusion Criteria:

• Patients who can receive hematopoietic stem cell transplantation from HLA-matched sibling or unrelated donors
• Patients who have anti-HLA antibodies
• Patients with any evidence of central nervous system (CNS) involvement of disease
• Patients with uncontrolled diabetes
• Patients with uncontrolled hypertension
• Patients with any evidence of active infection
• Positive for human immunodeficiency virus (HIV)
• Previous history of other malignancy within 5 years (Basal cell carcinoma of skin, cervical carcinoma in situ, and differentiated thyroid carcinoma with curative resection are permitted.)
• Women who are pregnant or breastfeeding
• Patients with previous history of allogeneic stem cell transplantation
• Patients with major psychotic disorder or drug/alcohol abuser
• Inappropriate patients according to the investigators' opinion