Status:
COMPLETED
Long Term Follow Up Of Patients Who Have Received Gene Therapy Or Gene Marked Products
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Severe Combined Immunodeficiency
Malignancy, Hematologic
Eligibility:
All Genders
Brief Summary
This protocol (GENEFU) provides a mechanism for the 15-year followup period that the FDA requires for all participants in gene transfer protocols and assures that adequate followup can be maintained f...
Detailed Description
Secondary objectives include the following: to obtain and archive blood samples to 1) detect frequency of vector marking in peripheral blood mononuclear cells when clinically or scientifically indicat...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Has received an integrating retroviral or lentiviral vector based GT/GM product at St. Jude Children's Research Hospital within the past 15 year time period. Patient is no later than 15 years post receipt of GT/GM product.
Exclusion
Key Trial Info
Start Date :
January 4 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 17 2024
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00695279
Start Date
January 4 2007
End Date
October 17 2024
Last Update
October 30 2024
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105