Long-term Follow-up of Gene Therapy for Radiation-Induced Xerostomia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AAV2-hAQP1.
- Who it may be relevant to
- Registry conditions: Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Long-term Follow-up of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia
Overview
This study will assess the long-term safety and efficacy of bilateral intra-parotid administration of AAV2-hAQP1 in adults with Grade 2 or Grade 3 radiation-induced late xerostomia.
Detailed description
Individual participation in this study will last approximately 48 months for participants who received AAV2-hAQP1 in Study MGT-AQP1-201 and at least 60 months for participants who receive AAV2-hAQP1 in Study MGT-AQP1-202.
Interventions
- Genetic AAV2-hAQP1
Administration of a prespecified concentration of AAV2-hAQP1 via Stensen's duct to each parotid gland
Primary outcome measures
- Number of participants with study drug-related adverse events and serious adverse events [Time frame: From study start until Month 60 post-treatment]
Eligibility criteria
Inclusion criteria
- Received study drug in Study MGT-AQP1-201
Exclusion criteria
- Withdrew consent to participate in Study MGT-AQP1-201.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 7 centers
- Banner MD Anderson Cancer Center — Gilbert
- Miami Cancer Institute at Baptist Health South Florida — Miami
- University of Iowa — Iowa City
- University of Missouri — Columbia
- Erie County Medical Center — Buffalo
- Atrium Health — Charlotte
- Alleghany General Hospital — Pittsburgh
Canada · 1 center
- Shirley and Jim Fielding Northeast Cancer Centre - Health Sciences North — Greater Sudbury
Identifiers
NCT: NCT06544798 · MGT-AQP1-202