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
  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 the investigators could expect a similar result.


Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Keio University:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 33
Study Start Date: January 2006
Study Completion Date: January 2011
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00270881

Locations
Japan
Keio University School of Medicine
Tokyo, Japan, 160-8582
Sponsors and Collaborators
Keio University
Investigators
Study Chair: Hisashi Sakamaki, M.D., Ph.D. Tokyo Metropolitan Komagome Hospital
  More Information

No publications provided

Responsible Party: Takehiko Mori, M.D., Ph.D., Dr., Keio University
ClinicalTrials.gov Identifier: NCT00270881     History of Changes
Other Study ID Numbers: KSGCT-CB2005
Study First Received: December 28, 2005
Last Updated: April 5, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Keio University:
cord blood transplantation
myeloablative regimen
hematologic malignancies

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Neoplasms
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Myelodysplastic Syndromes
Preleukemia
Leukemia
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Cyclophosphamide
Cytarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 16, 2014