Trial | NCT00270881  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    33
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.
Study Started
Jan 31
2006
Primary Completion
Jan 31
2009
Study Completion
Jan 31
2011
Last Update
Apr 06
2012
Estimate

Procedure Cord blood transplantation

unrelated cord blood transplantation

Radiation TBI

Total body irradiation (TBI) 12Gy

Drug cyclophosphamide

cyclophosphamide 120mg/kg

Drug cytarabine

cytarabine 3g/m2x4

Criteria 

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
No Results Posted