Recruiting

Gene Transfer

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT01492036

Conditions

Retroviridae Infections

Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Blood Tests

Questionnaires

Study Details

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

Study ID

NCT01492036

Start date

Dec 9, 2011

Status verified date

Jul, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

130 participants

Anticipated

Interventions and Outcome Measures

Arms

Gene Transfer Therapy

Study participants receiving gene therapy product at MD Anderson Cancer Center

Interventions

Blood Tests

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.

Questionnaires

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.

Primary outcome measure

  • Document Long-Term Safety of Gene-Transfer Research [ Time Frame: 15 years ]

Central Contacts and Locations

Central contacts

Partow Kebriaei, MD

713-792-8750pkebriae@mdanderson.org

Locations

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-07-15.