Status:

RECRUITING

Long-Term Follow-Up of Recipient of Gene Transfer Research

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborating Sponsors:

National Center for Research Resources (NCRR)

National Cancer Institute (NCI)

Conditions:

Retroviridae Infections

Cancer

Eligibility:

All Genders

Brief Summary

The goal of this clinical research study is to collect information about the long-term safety of gene transfer therapy. This study is also designed to create a database of medical information about pa...

Detailed Description

Study Procedures for Years 1-5: If you agree to take part in this study, you will come to the clinic for study visits once a year during Years 1-5. It is your choice whether to visit your regular loc...

Eligibility Criteria

Inclusion

  • Patient or patient's legal representative(s) provided written informed consent to participate in a gene transfer study at the University of Texas MD Anderson Cancer Center (MD Anderson).
  • Patient will receive vector or vector-treated cells at MD Anderson.
  • Patient or patient's legal representative(s) is/are able to provide written informed consent to participate in this long-term follow-up protocol for gene transfer participants for up to 15 years following administration of gene therapy product.
  • Agree to allow clinical samples to be collected and stored at MD Anderson and/or at a NIH designated facility such as the NGVB.

Exclusion

  • 1\) Subject's gene transfer protocol is not approved at MD Anderson Cancer Center.

Key Trial Info

Start Date :

December 9 2011

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2027

Estimated Enrollment :

130 Patients enrolled

Trial Details

Trial ID

NCT01492036

Start Date

December 9 2011

End Date

December 31 2027

Last Update

January 7 2026

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030