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

Phase 1

Completed

• Conditions: Acute Myelogenous Leukemia; Acute Lymphoblastic Leukemia; Chronic Myelogenous Leukemia; Myelodysplastic Syndrome

• Registration Number: NCT00270881
• Lead Sponsor: Keio University

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2005-12-28
• Study First Submitted QC: 2005-12-28
• Study First Posted: 2005-12-29
• Study Start: 2006-01
• Primary Completion: 2009-01
• Study Completion: 2011-01
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-05
• Last Update Posted: 2012-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Non-relapse mortality at 1 year	1 year

Secondary Outcome Measures

Name	Time	Method
Engraftment	day 56
Disease free survival	1 year
Overall survival	1 year
Incidence of acute and chronic graft-versus-host disease	day100 and 1 year
Incidence of infectious complication	1year
Duration of hospitalization	1 year
Immune reconstitution after transplantation	1 year

Trial Locations

Locations (1)

Keio University School of Medicine; 🇯🇵 Tokyo, Japan