Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome
Conditions
Keywords
cord blood transplantation, myeloablative regimen, hematologic malignancies
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.
Interventions
PROCEDURECord blood transplantation
unrelated cord blood transplantation
RADIATIONTBI
Total body irradiation (TBI) 12Gy
DRUGcyclophosphamide
cyclophosphamide 120mg/kg
DRUGcytarabine
cytarabine 3g/m2x4
Sponsors
Keio University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-relapse mortality at 1 year | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Disease free survival | 1 year |
| Overall survival | 1 year |
| Incidence of acute and chronic graft-versus-host disease | day100 and 1 year |
| Engraftment | day 56 |
| Duration of hospitalization | 1 year |
| Immune reconstitution after transplantation | 1 year |
| Incidence of infectious complication | 1year |
Countries
Japan
Outcome results
None listed