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

Study Overview
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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.

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.

Official Title
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Phase 1/2 Study of Cord Blood Transplantation From Unrelated Donor for Adult Patients With Hematologic Malignancies Using Myeloablative Conditioning Regimen

Conditions
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Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome

Intervention / Treatment
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* Procedure: Cord blood transplantation
* Radiation: TBI
* Drug: cyclophosphamide
* Drug: cytarabine


Participation Criteria
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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 Exclusion Criteria: Uncontrollable diabetes Uncontrollable hypertension Active infection TPHA, HBs-Ag, HCV-Ab positive HTLV-I, HIV positive

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-relapse mortality at 1 year |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cord blood transplantation, myeloablative regimen, hematologic malignancies