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Long Term Follow Up Of Patients Who Have Received Gene Therapy Or Gene Marked Products at St. Jude Children's Research Hospital


N/A
N/A
N/A
Open (Enrolling)
Both
Severe Combined Immunodeficiency, Malignancy, Hematologic, Neuroblastoma, Neoplasm, Mucopolysaccharidosis I

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Trial Information

Long Term Follow Up Of Patients Who Have Received Gene Therapy Or Gene Marked Products at St. Jude Children's Research Hospital


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 indicated, such as in the event of participant development of second
malignancy, autoimmune disease, hematologic abnormality, or neurologic event, and; 2) To
obtain and archive blood samples to detect and characterize clonal proliferation events
occurring in gene transfer trials when clinically or scientifically indicated.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Obtain histories for detection of significant delayed medical events events in research participants who have received an integrating vector-based gene therapy/gene marked product at St. Jude Children's Research Hospital (SJCRH).

Outcome Description:

Obtain histories for detection of significant delayed medical events including hematologic, malignant, autoimmune, and neurologic events in research participants who have received an integrating vector-based gene therapy/gene marked product at St. Jude Children's Research Hospital (SJCRH).

Outcome Time Frame:

30 years

Safety Issue:

No

Principal Investigator

Brian Sorrentino, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

GENEFU

NCT ID:

NCT00695279

Start Date:

December 2006

Completion Date:

December 2036

Related Keywords:

  • Severe Combined Immunodeficiency
  • Malignancy, Hematologic
  • Neuroblastoma
  • Neoplasm
  • Mucopolysaccharidosis I
  • Gene therapy
  • Neoplasms
  • Immunologic Deficiency Syndromes
  • Mucopolysaccharidosis I
  • Mucopolysaccharidoses
  • Neuroblastoma
  • Severe Combined Immunodeficiency
  • Hematologic Neoplasms

Name

Location
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794