Retroviridae InfectionsNCT01492036
Long-Term Follow-Up of Recipient of Gene Transfer Research
An observational study of Retroviridae Infections and Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Retroviridae Infections, Cancer
- What is being tested?
- Blood Tests and Questionnaires
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2011to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Gene transfer therapy in an M. D. Anderson Cancer Center research study in Houston, Texas
Who may be able to join
- 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.
Who cannot join
- 1) Subject's gene transfer protocol is not approved at MD Anderson Cancer Center.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Long-Term Follow-Up Study of Recipients of Gene Transfer Research Protocols
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.
Read the 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 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
- Retroviridae Infections, Cancer
- Being tested
- Blood Tests, Questionnaires
- 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
- Medical subject headings
- Retroviridae Infections, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood TestsOther
Also called Blood draw
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.
QuestionnairesBehavioural
Also called Surveys
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.
| Study group | Role | What they receive |
|---|---|---|
| Gene Transfer Therapy | Study participants receiving gene therapy product at MD Anderson Cancer Center Receives: Other: Blood Tests; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study start9 Dec 2011
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retroviridae InfectionsStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR), National Cancer Institute (NCI), Alaunos Therapeutics
- Responsible party
- Sponsor
- Investigators
- Partow Kebriaei, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492036
- Sponsor's protocol ID
- 2006-0676
- Other IDs
- R01CA124782, R01CA141303, NCI-2021-14027
- Status last verified
- Jul 2026
- First submitted
- 12 Dec 2011
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27482888
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-Up Study of Recipients of Gene Transfer Research Protocols
- ClinicalTrials.gov ID
- NCT01492036
- Acronym / sponsor ID
- 2006-0676
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR), National Cancer Institute (NCI), Alaunos Therapeutics
- Study start
- 9 Dec 2011 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gene Transfer Therapy | – | Other: Blood Tests, Behavioral: QuestionnairesStudy participants receiving gene therapy product at MD Anderson Cancer Center |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Gene transfer therapy in an M. D. Anderson Cancer Center research study in Houston, Texas
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 1) Subject's gene transfer protocol is not approved at MD Anderson Cancer Center.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood TestsAlso: Blood drawIf 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. | Other | Gene Transfer Therapy |
| QuestionnairesAlso: SurveysOnce 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. | Behavioural | Gene Transfer Therapy |
Primary outcome
Document Long-Term Safety of Gene-Transfer Research
Time frame: 15 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Derived from this study: PubMed 27482888Kebriaei 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.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Partow Kebriaei, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retroviridae Infections and Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Partow Kebriaei, MD (713-792-8750, pkebriae@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Document Long-Term Safety of Gene-Transfer Research (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01492036, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.