Clinical trial · Observational
Long-Term Follow-Up of Recipient of Gene Transfer Research
Long-Term Follow-Up Study of Recipients of Gene Transfer Research Protocols
NCT01492036CI-TRIAL-00118074recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Retroviridae Infections | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Tests | Other | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Gene Transfer Therapy
- description
- Study participants receiving gene therapy product at MD Anderson Cancer Center
- interventionNames
- Other: Blood Tests
- Behavioral: Questionnaires
Primary outcomes (1)
- measure
- Document Long-Term Safety of Gene-Transfer Research
- timeFrame
- 15 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDKebriaei 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