Trial Of Double Umbilical Cord Blood Transplantation

This study has been completed.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00763490
First received: September 30, 2008
Last updated: April 29, 2016
Last verified: April 2016
Results First Received: January 5, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hematological Malignancies
Interventions: Procedure: Full intensity, double umbilical cord, stem cell transplant
Drug: Flu/Bu4 conditioning regimen
Radiation: Total Lymphoid Irradiation (TLI)
Drug: Graft versus Host Disease prevention (GVHD prophylaxis)
Drug: Mycophenolate Mofetil

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Double Cord Blood Tranplant Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.

Participant Flow:   Overall Study
    Double Cord Blood Tranplant  
STARTED     20  
COMPLETED     20  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Double Cord Blood Tranplant Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.

Baseline Measures
    Double Cord Blood Tranplant  
Number of Participants  
[units: participants]
  20  
Age  
[units: years]
Mean (Full Range)
  41  
  (11 to 64)  
Gender  
[units: participants]
 
Female     9  
Male     11  



  Outcome Measures
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1.  Primary:   Percentage of Participants Alive at 1 Year After Transplant   [ Time Frame: 1 year ]

2.  Secondary:   Percentage of Patients Alive at the End of the Trial   [ Time Frame: 5 Years ]

3.  Secondary:   Cumulative Incidence of Neutrophil and Platelet Engraftment   [ Time Frame: Day 35 ]

4.  Secondary:   Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD)   [ Time Frame: Up to 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Daniel Couriel, M.D.
Organization: University of Michigan Comprehensive Cancer Center
phone: 734-936-8785
e-mail: dcouriel@umich.edu


Publications of Results:

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00763490     History of Changes
Other Study ID Numbers: umcc 2007.137
HUM00017515 ( Other Identifier: University of Michigan Medical IRB )
Study First Received: September 30, 2008
Results First Received: January 5, 2015
Last Updated: April 29, 2016
Health Authority: United States: Institutional Review Board