REVIVE Prospective Registry Cohort Study

Official title

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

Overview

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.

Detailed description

This is an observational registry with a non-experimental cohort design that will provide long-term safety and effectiveness data from participants who participated in the REVIVE clinical study. Participants will be enrolled by either of the two participating sites. All visits will be conducted either remotely or in person. The objectives of this study are to:

* Evaluate the long-term safety of iltamiocel * Evaluate the long-term effectiveness of iltamiocel treatment as demonstrated through anterior tongue strength and patient reported outcomes (PROs) related to tongue dysphagia (TD) symptoms, quality of life (QOL), and overall satisfaction.

The duration of participants' participation in this registry will extend to 5 years after enrollment. This is an observational registry with a non-experimental cohort design that will provide long-term safety and effectiveness data from participants who participated in the REVIVE clinical study. Participants will be enrolled by either of the two participating sites. All visits will be conducted either remotely or in person.

Interventions

• Other Other: No Intervention (subjects were previously treated with Iltamiocel). This is a observational study and all participants will be observed with no intervention.
  Participants are followed observationally to collect long-term safety and effectiveness data after prior receipt of iltamiocel in the separate Revive clinical trial; no intervention is administered as part of this registry. Long-term safety outcomes and efficacy will be separated in analysis \& reporting

Primary outcome measures

• Number of Participants With Iltamiocel-Related Adverse Events and Serious Adverse Events [Time frame: From baseline through 5 years of follow-up, assessed annually]
• Change From Baseline in Anterior Tongue Pressure as Measured by Iowa Oral Performance Instrument (IOPI) [Time frame: Baseline and annually up to 5 years]

Secondary outcome measures (4)

• Change From Baseline in Dysphagia Symptoms as Measured by Eating Assessment Tool (EAT-10) [Time frame: Baseline and annually up to 5 years]
• Change From Baseline in Smell and Taste Function as Measured by ChemoSensory Smell and Taste Questionnaire (CSQ) [Time frame: Baseline and annually up to 5 years]
• Change From Baseline in Functional Oral Intake as Measured by Functional Oral Intake Scale (FOIS) [Time frame: Baseline and annually up to 5 years]
• Change From Baseline in Dysphagia-Related Quality of Life as Measured by MD Anderson Dysphagia Inventory (MDADI) [Time frame: Baseline and annually up to 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 2 centers

• UC Davis Medical Center — Sacramento
• UC SanFrancisco Medical Center — San Francisco

Identifiers

NCT: NCT07429890 · 2405778

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗