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

NCT01492036 | Recruiting DMC

• 4 other identifiers: 2006-0676R01CA124782R01CA141303NCI-2021-14027
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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 patients who have received gene transfer therapy, in order for researchers to track and review the long-term safety and any effects (good or bad) of gene transfer therapy.

Conditions

Retroviridae Infections; Cancer

Keywords

Replication-Competent Retrovirus; RCR; Gene transfer therapy; Registry; Medical information database; Vector or vector-treated cells; Blood draw; Computed tomography; CT; Questionnaires; Surveys; Gene Transfer Research; National Gene Vector Biorepository and Coordinating Center; NGVB

Outcome Measures

Primary Outcomes (1)

• Document Long-Term Safety of Gene-Transfer Research

  First 5 years following infusion of vector or vector-treated cells: Participants evaluated on annual basis. Years 6 to 15 following infusion of vector or vector-treated cells: Participants mailed questionnaires. Participants in retroviral studies: Up to 60 mL (max 1 mL/kg) blood will be obtained to check for replication-competent retrovirus (RCR) every 3 months during the first year, and then blood archived annually thereafter. Replication competent vector testing performed when there is a clinical indication or when requested by the FDA.

  15 years

Study Arms (1)

Gene Transfer Therapy

Study participants receiving gene therapy product at MD Anderson Cancer Center

Other: Blood Tests; Behavioral: Questionnaires

Interventions

Blood Tests OTHER

If participant received retroviral gene therapy, blood test performed to check for a type of infection called the replication-competent retrovirus (RCR). Blood (up to 4 tablespoons each time) drawn every 3 months for first year after gene transfer therapy and once a year after that.

Also known as: Blood draw

Gene Transfer Therapy

Questionnaires BEHAVIORAL

Once a year during Years 1-5, questionnaire completions that asks about medical history (general health, the status of any medical conditions, and any illnesses or hospitalizations that may have occurred). It should take about 15-30 minutes to complete. Once a year during Years 6-15, completion of mailed questionnaire. Participant will be asked about medical history (including if participant has had any children since the infusion) and whether there have been any changes in contact information. The questionnaires should take about 15-30 minutes each time.

Also known as: Surveys

Gene Transfer Therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Gene transfer therapy in an M. D. Anderson Cancer Center research study in Houston, Texas

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Center for Research Resources (NCRR): collaborator
• National Cancer Institute (NCI): collaborator
• Alaunos Therapeutics: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

• Kebriaei P, Singh H, Huls MH, Figliola MJ, Bassett R, Olivares S, Jena B, Dawson MJ, Kumaresan PR, Su S, Maiti S, Dai J, Moriarity B, Forget MA, Senyukov V, Orozco A, Liu T, McCarty J, Jackson RN, Moyes JS, Rondon G, Qazilbash M, Ciurea S, Alousi A, Nieto Y, Rezvani K, Marin D, Popat U, Hosing C, Shpall EJ, Kantarjian H, Keating M, Wierda W, Do KA, Largaespada DA, Lee DA, Hackett PB, Champlin RE, Cooper LJ. Phase I trials using Sleeping Beauty to generate CD19-specific CAR T cells. J Clin Invest. 2016 Sep 1;126(9):3363-76. doi: 10.1172/JCI86721. Epub 2016 Aug 2.

  PMID: 27482888 DERIVED

Related Links

• MD Anderson Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

Study visits once a year during Years 1-5. Blood (about 2-4 tablespoons each time) drawn for routine tests. If retroviral gene transfer therapy received, blood (up to 4 tablespoons each time) drawn every 3 months for first year after gene transfer therapy and once a year after that. If joining study more than a year after gene transfer therapy, RCR test performed once a year for all 15 years of the study.

MeSH Terms

Conditions

Retroviridae Infections; Neoplasms

Interventions

Hematologic Tests; Blood Specimen Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Specimen Handling; Punctures; Surgical Procedures, Operative; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Partow Kebriaei, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Partow Kebriaei, MD

CONTACT

713-792-8750; pkebriae@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: December 14, 2011
• Study Start: December 9, 2011
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (1)