Partially Matched Stem Cell Transplantation for Patients With Refractory Severe Aplastic Anemia or Refractory Cytopenias

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00244010
First received: October 24, 2005
Last updated: May 1, 2012
Last verified: February 2009
Results First Received: February 2, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Anemia, Aplastic
Amegakaryocytic Thrombocytopenia
Diamond-Blackfan Anemia
Kostmann Syndrome
Intervention: Device: Allogeneic stem cell 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
Two patients and two donors were enrolled between 10/24/2005 and 2/24/2009 when the study was closed. The study was terminated due to the PI leaving St. Jude.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Patients Patients were enrolled to treat refractory severe aplastic anemia.
Donors Parents of patients were enrolled onto the SAAHAP study to provide hematopoietic stem cells.

Participant Flow:   Overall Study
    Patients     Donors  
STARTED     2     2  
COMPLETED     2     2  
NOT COMPLETED     0     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.
No text entered.

Reporting Groups
  Description
Patients Patients were enrolled to treat refractory severe aplastic anemia.
Donors Parents of patients were enrolled onto the SAAHAP study to provide hematopoietic stem cells.
Total Total of all reporting groups

Baseline Measures
    Patients     Donors     Total  
Number of Participants  
[units: participants]
  2     2     4  
Age  
[units: participants]
     
<=18 years     2     0     2  
Between 18 and 65 years     0     2     2  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     2     1     3  
Male     0     1     1  



  Outcome Measures

1.  Primary:   Treatment Failures   [ Time Frame: 100 days 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
This study has terminated due to the PI leaving the institution. An insufficient number of subjects were enrolled to answer the primary objective.


  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: Kimberly Kasow, DO
Organization: St. Jude Children's Research Hospital
phone: 901-595-3300
e-mail: kimberly_kasow@med.unc.edu


No publications provided


Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00244010     History of Changes
Other Study ID Numbers: SAAHAP, Severe Aplastic Anemia, Cytopenias
Study First Received: October 24, 2005
Results First Received: February 2, 2012
Last Updated: May 1, 2012
Health Authority: United States: Food and Drug Administration