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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Takehiko Mori, M.D., Ph.D., Keio University

ClinicalTrials.gov Identifier:

NCT00270881

First received: December 28, 2005

Last updated: April 5, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 28, 2005

Last Updated Date

April 5, 2012

Start Date ^ICMJE

January 2006

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Non-relapse mortality at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Non-relapse mortality at 1 year

Change History

Complete list of historical versions of study NCT00270881 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Engraftment [ Time Frame: day 56 ] [ Designated as safety issue: Yes ]
Disease free survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Incidence of acute and chronic graft-versus-host disease [ Time Frame: day100 and 1 year ] [ Designated as safety issue: Yes ]
Incidence of infectious complication [ Time Frame: 1year ] [ Designated as safety issue: Yes ]
Duration of hospitalization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Immune reconstitution after transplantation [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Acute Myelogenous Leukemia
Acute Lymphoblastic Leukemia
Chronic Myelogenous Leukemia
Myelodysplastic Syndrome

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2011

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00270881

Other Study ID Numbers ^ICMJE

KSGCT-CB2005

Has Data Monitoring Committee

Yes

Responsible Party

Takehiko Mori, M.D., Ph.D., Keio University

Study Sponsor ^ICMJE

Keio University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Hisashi Sakamaki, M.D., Ph.D.

Tokyo Metropolitan Komagome Hospital

Information Provided By

Keio University

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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