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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborators:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01492036
First received: December 12, 2011
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Retroviridae Infections
Cancer
Other: Blood Tests
Behavioral: Questionnaires

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-Term Follow-Up Study of Recipients of Gene Transfer Research Protocols

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Document Long-Term Safety of Gene-Transfer Research [ Time Frame: 15 years ] [ Designated as safety issue: No ]
    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.


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.


Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Primary Completion Date: December 2026 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Gene Transfer Therapy
Study participants receiving gene therapy product at MD Anderson Cancer Center
Other: 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.
Other Name: Blood draw
Behavioral: 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.

Other Name: Surveys

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  5. Dr. Laurence Cooper is a Co-Chair or Collaborator on the vector or vector-treated cell protocol.

Exclusion Criteria:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492036

Contacts
Contact: Laurence JN Cooper, MD,PHD 713-792-6620

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Laurence JN Cooper, MD, PHD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01492036     History of Changes
Other Study ID Numbers: 2006-0676, R01CA124782, R01CA141303
Study First Received: December 12, 2011
Last Updated: September 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
Retroviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014