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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia Chronic Myelogenous Leukemia Myelodysplastic Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Cord blood transplantation

unrelated cord blood transplantation

Intervention Type PROCEDURE

TBI

Total body irradiation (TBI) 12Gy

Intervention Type RADIATION

cyclophosphamide

cyclophosphamide 120mg/kg

Intervention Type DRUG

cytarabine

cytarabine 3g/m2x4

Intervention Type DRUG

Eligibility Criteria

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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