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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

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ClinicalTrials.gov Identifier: NCT00673114
Recruitment Status : Completed
First Posted : May 7, 2008
Results First Posted : December 24, 2013
Last Update Posted : April 3, 2015
Sponsor:
Collaborator:
Miltenyi Biotec GmbH
Information provided by (Responsible Party):
Joanne Kurtzberg, MD, Duke University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hematologic Malignancy
Myelodysplastic Syndrome (MDS)
Aplastic Anemia
Intervention Biological: haplo/cord transplant
Enrollment 3
Recruitment Details Three patients enrolled.
Pre-assignment Details  
Arm/Group Title Transplant Recipients
Hide Arm/Group Description Transplant Recipients
Period Title: Overall Study
Started 3
Completed 3
Not Completed 0
Arm/Group Title Transplant Recipients
Hide Arm/Group Description single arm study
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
1
  33.3%
Between 18 and 65 years
2
  66.7%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants
16.3  (3.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
1
  33.3%
Male
2
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title The Number of Participants Reaching Primary Endpoint of Absolute Neutrophil Count (ANC) of 500/uL (Engraftment).
Hide Description [Not Specified]
Time Frame By day 100
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transplant Recipients
Hide Arm/Group Description:
single arm study
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
3
2.Secondary Outcome
Title 180 Day Survival
Hide Description Number of participants alive at 180 days post transplant
Time Frame 180 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transplant Recipients
Hide Arm/Group Description:
single arm study
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
3
3.Secondary Outcome
Title Non-Relapse Mortality at 180 Days Post Transplant
Hide Description [Not Specified]
Time Frame 180 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transplant Recipients
Hide Arm/Group Description:
single arm study
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
0
4.Secondary Outcome
Title Platelet Engraftment (Untransfused and Platelet Count > 50,000)
Hide Description Participants platelet engrafted.
Time Frame Approximately 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transplant Recipients
Hide Arm/Group Description:
single arm study
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
3
5.Secondary Outcome
Title Incidence of Primary and Secondary Graft Failure
Hide Description Number of participants experiencing graft failure.
Time Frame 100 days post transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transplant Recipients
Hide Arm/Group Description:
single arm study
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
0
6.Secondary Outcome
Title Number of Participants With Acute or Chronic Graft-versus-host Disease (GVHD)
Hide Description Acute and chronic GVHD
Time Frame two years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transplant Recipients
Hide Arm/Group Description:
single arm study
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
2
7.Secondary Outcome
Title Rates of Leukemic Relapse
Hide Description Number of participants relapsed
Time Frame Up to 2 years post transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transplant Recipients
Hide Arm/Group Description:
single arm study
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
1
8.Secondary Outcome
Title Number of Participants With Donor Cells at 100 Days Post-transplant
Hide Description [Not Specified]
Time Frame Post transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transplant Recipients
Hide Arm/Group Description:
single arm study
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Transplant Recipients
Hide Arm/Group Description single arm study
All-Cause Mortality
Transplant Recipients
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Transplant Recipients
Affected / at Risk (%) # Events
Total   2/3 (66.67%)    
Blood and lymphatic system disorders   
Relapse  [1]  1/3 (33.33%)  1
General disorders   
Chronic GVHD  [2]  1/3 (33.33%)  1
Multi-system organ failure  [2]  1/3 (33.33%)  1
Infections and infestations   
Encephalitis infection  [1]  1/3 (33.33%)  1
Sepsis  [2]  1/3 (33.33%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonia  [2]  1/3 (33.33%)  1
Respiratory Failure  [2]  1/3 (33.33%)  1
Indicates events were collected by systematic assessment
[1]
Not study related and not unexpected per the PI.
[2]
Not directly related to the study and not unexpected per the PI.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Transplant Recipients
Affected / at Risk (%) # Events
Total   0/3 (0.00%)    
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
Responsible Party: Joanne Kurtzberg, MD, Duke University
ClinicalTrials.gov Identifier: NCT00673114     History of Changes
Other Study ID Numbers: Pro00008292
8717 ( Other Identifier: Duke Legacy IRB Number )
First Submitted: December 27, 2007
First Posted: May 7, 2008
Results First Submitted: May 8, 2013
Results First Posted: December 24, 2013
Last Update Posted: April 3, 2015