Long-term follow-up for patients receiving gene transfer therapy
Long-Term Follow-Up Study of Recipients of Gene Transfer Research Protocols
This study is checking how safe gene transfer therapy is for people who have been treated for certain infections or cancer by following their health over many years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT01492036 on ClinicalTrials.gov |
What this trial studies
This clinical research focuses on the long-term safety of gene transfer therapy for patients who have received treatment for Retroviridae infections or cancer. Participants will visit the clinic annually for the first five years for routine blood tests, physical exams, and questionnaires about their health status. From years six to fifteen, researchers will maintain contact with participants to gather ongoing medical history information. The goal is to create a comprehensive database to track the effects of gene transfer therapy over time.
Who should consider this trial
Good fit: Ideal candidates are individuals who have previously participated in a gene transfer study at MD Anderson and are able to provide informed consent.
Not a fit: Patients whose gene transfer protocols are not approved at MD Anderson will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and efficacy of gene transfer therapies, potentially improving treatment protocols.
How similar studies have performed: While gene transfer therapies are being explored in various contexts, this long-term follow-up approach is relatively novel and aims to fill gaps in existing knowledge.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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). 2. Patient will receive vector or vector-treated cells at MD Anderson. 3. 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. 4. 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 Criteria: 1\) Subject's gene transfer protocol is not approved at MD Anderson Cancer Center.
Where this trial is running
Houston, Texas
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Partow Kebriaei, MD — M.D. Anderson Cancer Center
- Study coordinator: Partow Kebriaei, MD
- Email: pkebriae@mdanderson.org
- Phone: 713-792-8750
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.