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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Follow-up group | No Intervention | Participants who were randomized to AAV2-hAQP1 treatment in Study MGT-AQP1-201 will continue in this long-term follow-up schedule to complete an additional 48 months of follow-up after their end-of-study visit in Study MGT-AQP1-201. All study participants are to be followed for a period of 60 months after vector administration. | |
| Active treatment group | Experimental | Participants who were randomized to placebo treatment in Study MGT-AQP1-201, will be offered to transition from the long-term follow-up schedule to an active treatment schedule at the time of unblinding. Study drug administration should be completed after unblinding and after confirmation of the participant's continued eligibility for treatment. Upon completion of the 12-month primary treatment period, participants will continue in the study according to a follow-up schedule, to complete a total of 60 months of follow-up after AAV2-hAQP1 administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AAV2-hAQP1 | Genetic | Administration of a prespecified concentration of AAV2-hAQP1 via Stensen's duct to each parotid gland |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with study drug-related adverse events and serious adverse events | From study start until Month 60 post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| Miami Cancer Institute at Baptist Health South Florida |
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Participants will be assigned to the follow-up group or active treatment group based on the group to which they were randomized in Study MGT-AQP1-201.
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| Miami |
| Florida |
| 33176 |
| United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| University of Missouri | Columbia | Missouri | 65212 | United States |
| Erie County Medical Center | Buffalo | New York | 14215 | United States |
| Atrium Health | Charlotte | North Carolina | 28209 | United States |
| Alleghany General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Shirley and Jim Fielding Northeast Cancer Centre - Health Sciences North | Greater Sudbury | Ontario | P3E 5J1 | Canada |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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