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Trial Of Double Umbilical Cord Blood Transplantation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00763490
First Posted: October 1, 2008
Last Update Posted: December 23, 2016
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.
Collaborator:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
University of Michigan Cancer Center
Results First Submitted: January 5, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Years]
Mean (Full Range)
 41 
 (11 to 64) 
Gender 
[Units: Participants]
Count of Participants
 
Female      9  45.0% 
Male      11  55.0% 


  Outcome Measures
  Show All Outcome Measures

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 )
First Submitted: September 30, 2008
First Posted: October 1, 2008
Results First Submitted: January 5, 2015
Results First Posted: January 12, 2015
Last Update Posted: December 23, 2016