Unrelated Cord Blood Transplant Plus a Haplo-Identical (Half-Matched), T-Cell Depleted Stem Transplant From a Related Donor for Subjects With High Risk Malignancies

This study has been completed.
Miltenyi Biotec GmbH
Information provided by (Responsible Party):
Joanne Kurtzberg, MD, Duke University Medical Center
ClinicalTrials.gov Identifier:
First received: December 27, 2007
Last updated: March 16, 2015
Last verified: March 2015
Results First Received: May 8, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hematologic Malignancy
Myelodysplastic Syndrome (MDS)
Aplastic Anemia
Intervention: Biological: haplo/cord transplant

  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
Three patients enrolled.

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
Transplant Recipients Transplant Recipients

Participant Flow:   Overall Study
    Transplant Recipients  
STARTED     3  

  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
Transplant Recipients single arm study

Baseline Measures
    Transplant Recipients  
Number of Participants  
[units: participants]
[units: participants]
<=18 years     1  
Between 18 and 65 years     2  
>=65 years     0  
[units: years]
Mean (Standard Deviation)
  16.3  (3.0)  
[units: participants]
Female     1  
Male     2  
Region of Enrollment  
[units: participants]
United States     3  

  Outcome Measures
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1.  Primary:   The Number of Participants Reaching Primary Endpoint of Absolute Neutrophil Count (ANC) of 500/uL (Engraftment).   [ Time Frame: By day 100 ]

2.  Secondary:   180 Day Survival   [ Time Frame: 180 days ]

3.  Secondary:   Non-Relapse Mortality at 180 Days Post Transplant   [ Time Frame: 180 days ]

4.  Secondary:   Platelet Engraftment (Untransfused and Platelet Count > 50,000)   [ Time Frame: Approximately 1 year ]

5.  Secondary:   Incidence of Primary and Secondary Graft Failure   [ Time Frame: 100 days post transplant ]

6.  Secondary:   Number of Participants With Acute or Chronic Graft-versus-host Disease (GVHD)   [ Time Frame: two years ]

7.  Secondary:   Rates of Leukemic Relapse   [ Time Frame: Up to 2 years post transplant ]

8.  Secondary:   Number of Participants With Donor Cells at 100 Days Post-transplant   [ Time Frame: Post transplant ]

  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. Joanne Kurtzberg
Organization: Duke University Medical Center
phone: 919-668-1100
e-mail: kurtz001@mc.duke.edu

Responsible Party: Joanne Kurtzberg, MD, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00673114     History of Changes
Other Study ID Numbers: Pro00008292
8717 ( Other Identifier: Duke Legacy IRB Number )
Study First Received: December 27, 2007
Results First Received: May 8, 2013
Last Updated: March 16, 2015
Health Authority: United States: Food and Drug Administration