Back to resultsSafety and Efficacy of Unrelated Cord Blood Transplantation for Adult Patients With Hematologic Malignancies
Primary Purpose
Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Cord blood transplantation
TBI
cyclophosphamide
cytarabine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myelogenous Leukemia focused on measuring cord blood transplantation, myeloablative regimen, hematologic malignancies
Eligibility Criteria
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
Sites / Locations
- Keio University School of Medicine
Outcomes
Primary Outcome Measures
Non-relapse mortality at 1 year
Secondary Outcome Measures
Engraftment
Disease free survival
Overall survival
Incidence of acute and chronic graft-versus-host disease
Incidence of infectious complication
Duration of hospitalization
Immune reconstitution after transplantation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00270881
Brief Title
Safety and Efficacy of Unrelated Cord Blood Transplantation for Adult Patients With Hematologic Malignancies
Official Title
Phase 1/2 Study of Cord Blood Transplantation From Unrelated Donor for Adult Patients With Hematologic Malignancies Using Myeloablative Conditioning Regimen
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Keio University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome
Keywords
cord blood transplantation, myeloablative regimen, hematologic malignancies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Cord blood transplantation
Intervention Description
unrelated cord blood transplantation
Intervention Type
Radiation
Intervention Name(s)
TBI
Intervention Description
Total body irradiation (TBI) 12Gy
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Description
cyclophosphamide 120mg/kg
Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Description
cytarabine 3g/m2x4
Primary Outcome Measure Information:
Title
Non-relapse mortality at 1 year
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Engraftment
Time Frame
day 56
Title
Disease free survival
Time Frame
1 year
Title
Overall survival
Time Frame
1 year
Title
Incidence of acute and chronic graft-versus-host disease
Time Frame
day100 and 1 year
Title
Incidence of infectious complication
Time Frame
1year
Title
Duration of hospitalization
Time Frame
1 year
Title
Immune reconstitution after transplantation
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hisashi Sakamaki, M.D., Ph.D.
Organizational Affiliation
Tokyo Metropolitan Komagome Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Keio University School of Medicine
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Unrelated Cord Blood Transplantation for Adult Patients With Hematologic Malignancies
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