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

December 28, 2005
April 5, 2012
January 2006
January 2009   (final data collection date for primary outcome measure)
Non-relapse mortality at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Non-relapse mortality at 1 year
Complete list of historical versions of study NCT00270881 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
Safety and Efficacy of Unrelated Cord Blood Transplantation for Adult Patients With Hematologic Malignancies
Phase 1/2 Study of Cord Blood Transplantation From Unrelated Donor for Adult Patients With Hematologic Malignancies Using Myeloablative Conditioning Regimen

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Myelogenous Leukemia
  • Acute Lymphoblastic Leukemia
  • Chronic Myelogenous Leukemia
  • Myelodysplastic Syndrome
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
January 2011
January 2009   (final data collection date for primary outcome measure)

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
Both
20 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00270881
KSGCT-CB2005
Yes
Takehiko Mori, M.D., Ph.D., Keio University
Keio University
Not Provided
Study Chair: Hisashi Sakamaki, M.D., Ph.D. Tokyo Metropolitan Komagome Hospital
Keio University
April 2012

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