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


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

This study is not yet open for patient recruitment.
Verified by Keio University December 2005

Sponsored by: Keio University
Information provided by: Keio University
ClinicalTrials.gov Identifier: NCT00270881

Purpose

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 we could expect a similar result.
Condition Intervention Phase
Acute Myelogenous Leukemia
Acute Lymphoblastic Leukemia
Chronic Myelogenous Leukemia
Myelodysplastic Syndrome
  Procedure: Cord blood transplantation
 Phase I
Phase II

MedlinePlus related topics:  Anemia;   Blood and Blood Disorders;   Bone Marrow Diseases;   Cancer;   Cancer Alternative Therapies;   Immune System and Disorders;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphatic Diseases

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Keio University:
Primary Outcomes: Non-relapse mortality at 1 year
Secondary Outcomes: 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
Expected Total Enrollment:  50

Study start: January 2006;  Expected completion: December 2008
Last follow-up: December 2008;  Data entry closure: December 2008

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 significantlly better than that of bone marrow transplantatio 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.

Eligibility

Ages Eligible for Study:  20 Years   -   55 Years,  Genders Eligible for Study:  Both
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

-

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00270881

Hisashi Sakamaki, M.D., Ph.D.      81-3-3823-2101    sakamaki@cick.jp
Takehiko Mori, M.D., Ph.D.      81-3-3353-1211  Ext. 61357    tmori@sc.itc.keio.ac.jp

Japan
      Keio University School of Medicine, Tokyo,  160-8582,  Japan
Takehiko Mori, M.D., Ph.D.  81-3-3353-1211  Ext. 61357    tmori@sc.itc.keio.ac.jp 

Study chairs or principal investigators

Hisashi Sakamaki, M.D., Ph.D.,  Study Chair,  Tokyo Metropolitan Komagome Hospital   

More Information

Study ID Numbers:  KSGCT-CB2005
Last Updated:  December 28, 2005
Record first received:  December 28, 2005
ClinicalTrials.gov Identifier:  NCT00270881
Health Authority: Japan: Kanto Study Group for Cell Therapy
ClinicalTrials.gov processed this record on 2006-01-10


Source: ClinicalTrials.gov
Cache Date: January 11, 2006

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Page Updated: September 6, 2005
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