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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-09

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Feasibility Study of Collecting Multicenter Chronic GVHD Data

NCT00506233

Graft-Versus-Host Disease

COMPLETED

A Safety and Efficacy Long-Term Follow-up Study of Adult Participants Treated With Gene Modified T Cells

NCT06798298

Long Term Safety Following GM T Cell Therapy

RECRUITING

Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants

NCT00106925

Graft-versus-leukemia Graft vs Host Disease Graft Rejection

RECRUITING

Long-term Follow-up After Adoptive Transfer of Genetically Modified Cell Products

NCT05713214

Relapsed Hematologic Malignancy Refractory Hematologic Malignancy

RECRUITING

Follow-up of Breast Cancer and Multiple Myeloma Patients Previously Enrolled in NIH Gene Therapy Studies

NCT00427726

Gene Transfer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 local doctor or your study doctor at MD Anderson. (If you visit your regular local doctor, you will need to have your test results and blood samples mailed to the study staff.) You will receive a reminder phone call once a year, when it is time to schedule these visits.

At these visits, the following procedures will be performed:

* Blood (about 2-4 tablespoons each time) will be drawn for routine tests.
* You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
* You will fill out a questionnaire that asks about your medical history (your 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.
* You will be asked if there have been any changes in your contact information.
* If necessary to check the status of the disease, you will have scans (x-rays and/or computed tomography \[CT\] scans) and/or additional routine blood tests (about 1-2 tablespoons).

Study Procedures for Years 6-15:

Once a year during Years 6-15, the research staff will contact you. Either over the phone, by email, or by mail (but usually by mail, with an enclosed questionnaire), you will be asked about your medical history (including if you have had any children since the infusion) and whether there have been any changes in your contact information. The phone calls and questionnaires should take about 15-30 minutes each time.

Results of Study Testing:

If any of the tests that are performed in this study suggest that you may have a medical condition and/or side effect that is likely to be related to the gene transfer therapy, the study doctor will contact you. You will receive a referral in case you would like to seek medical care for the condition and/or side effect.

You and/or your insurance provider will be responsible for the costs of any CT scans and x-rays that may be needed for this study.

Study Database:

Your medical information that is collected for this study will be stored in a research database at MD Anderson for use in future research related to the safety and effects of gene transfer therapy.

Your data will be given a code number. No identifying information will be directly linked to your data. Only the researcher or authorized personnel in charge of the database will have access to the code numbers and be able to link the data to you. This is to allow medical information related to your data to be updated as needed. Other researchers using your data will not be able to link this data to you.

Changes in Parent/Guardian Contact:

If you are younger than 18 years old when joining this study but turn 18 during this study, starting then, the research staff will contact you directly for this study instead of your parent/guardian. However, if you would prefer for your parent/guardian to still be the main contact person, please tell the study staff.

Length of Study Participation:

After 15 years, your participation in this study will be over unless the FDA decides that follow-up must continue.

This is an investigational study.

Up to 130 patients will take part in this study. All will be enrolled at MD Anderson.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retroviridae Infections Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Gene Transfer Therapy

Study participants receiving gene therapy product at MD Anderson Cancer Center

Blood Tests

Intervention Type 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.

Questionnaires

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Blood draw Surveys

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.