Clinical trial · Observational
REVIVE Prospective Registry Cohort Study
Prospective Observational Long-Term Safety and Effectiveness Registry of Patients Who Have Received Iltamiocel as Part of REVIVE Clinical Study in Patients With Tongue Dysphagia Resulting From the Treatment of Head and Neck Cancer
NCT07429890CI-TRIAL-00115164not yet recruitingClinicalTrials.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 main purpose of this registry is to collect observational, long-term safety and effectiveness data in participants who have received iltamiocel as part of the blinded portion of the REVIVE clinical study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oropharyngeal Dysphagia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Other: No Intervention (subjects were previously treated with Iltamiocel). This is a observational study and all participants will be observed with no intervention. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Tongue Dysphagia Oropharyngeal Cancer
- description
- Patients with Oropharyngeal cancer who have received Iltamiocel as part of REVIVE Clinical Study
- interventionNames
- Other: Other: No Intervention (subjects were previously treated with Iltamiocel). This is a observational study and all participants will be observed with no intervention.
Primary outcomes (2)
- measure
- Number of Participants With Iltamiocel-Related Adverse Events and Serious Adverse Events
- timeFrame
- From baseline through 5 years of follow-up, assessed annually
- description
- Iltamiocel-related adverse events (AEs) and iltamiocel-related serious adverse events (SAEs) assessed by the investigator. Long-term safety outcomes and efficacy outcomes will be separated in analysis and reporting.
- measure
- Change From Baseline in Anterior Tongue Pressure as Measured by Iowa Oral Performance Instrument (IOPI)
- timeFrame
- Baseline and annually up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants who have received iltamiocel as part of participation in the REVIVE clinical study for males and females with tongue dysphagia (TD) are eligible, provided the following criteria are fulfilled: * Has completed the Month 24 visit in the REVIVE study. * Has received iltamiocel as part of the blinded portion of the REVIVE study. * Must be willing and able to comply with the study procedures, is able to understand all study requirements and must agree to read and sign the informed consent form prior to any study-related procedures. Exclusion Criteria: * The following criteria will exclude participants from participation: * Has received placebo as part of the blinded portion of the REVIVE study. * Unable or unwilling to provide informed consent. * Not available for, or willing to comply with the follow-up evaluations as required by the protocol.
References
Publications (0)
Data not yet available
No reference posted for this study.