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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00270881
Recruitment Status : Completed
First Posted : December 29, 2005
Last Update Posted : April 6, 2012
Sponsor:
Information provided by (Responsible Party):
Takehiko Mori, M.D., Ph.D., Keio University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia Chronic Myelogenous Leukemia Myelodysplastic Syndrome Procedure: Cord blood transplantation Radiation: TBI Drug: cyclophosphamide Drug: cytarabine Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of Cord Blood Transplantation From Unrelated Donor for Adult Patients With Hematologic Malignancies Using Myeloablative Conditioning Regimen
Study Start Date : January 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • 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

Outcome Measures
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Primary Outcome Measures :
  1. Non-relapse mortality at 1 year [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Engraftment [ Time Frame: day 56 ]
  2. Disease free survival [ Time Frame: 1 year ]
  3. Overall survival [ Time Frame: 1 year ]
  4. Incidence of acute and chronic graft-versus-host disease [ Time Frame: day100 and 1 year ]
  5. Incidence of infectious complication [ Time Frame: 1year ]
  6. Duration of hospitalization [ Time Frame: 1 year ]
  7. Immune reconstitution after transplantation [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00270881


Locations
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Japan
Keio University School of Medicine
Tokyo, Japan, 160-8582
Sponsors and Collaborators
Keio University
Investigators
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Study Chair: Hisashi Sakamaki, M.D., Ph.D. Tokyo Metropolitan Komagome Hospital
More Information
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Responsible Party: Takehiko Mori, M.D., Ph.D., Dr., Keio University
ClinicalTrials.gov Identifier: NCT00270881    
Other Study ID Numbers: KSGCT-CB2005
First Posted: December 29, 2005    Key Record Dates
Last Update Posted: April 6, 2012
Last Verified: April 2012
Keywords provided by Takehiko Mori, M.D., Ph.D., Keio University:
cord blood transplantation
myeloablative regimen
hematologic malignancies
Additional relevant MeSH terms:
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Leukemia
Neoplasms
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Hematologic Neoplasms
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Myeloproliferative Disorders
Neoplasms by Site
Cytarabine
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic