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

Keio University

Status and phase

Completed

Phase 2

Phase 1

Conditions

Acute Myelogenous Leukemia

Chronic Myelogenous Leukemia

Acute Lymphoblastic Leukemia

Myelodysplastic Syndrome

Treatments

Drug: cyclophosphamide

Procedure: Cord blood transplantation

Radiation: TBI

Drug: cytarabine

Study type

Interventional

Funder types

Other

Identifiers

NCT00270881

KSGCT-CB2005

Details and patient eligibility

About

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.

Full 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.

Enrollment

33 patients

Sex

All

Ages

20 to 55 years old

Volunteers

No Healthy Volunteers

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