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NCT04484532 · ClinicalTrials.gov registry record · Early Phase 1
Evaluation of Antibody Response to High-Dose Seasonal Influenza Vaccination in Patients With Myeloid Malignancy Receiving Chemotherapy and Healthy Volunteers
A Early Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Roswell Park Cancer Institute.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 130
- Enrollment target
- 1
- Study location
NCT04484532: Completed Early Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Roswell Park Cancer Institute.
NCT04484532 is a Early Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 130 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (13% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04484532, a Early Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, has completed, sponsored by Roswell Park Cancer Institute.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 130 participants
- Enrollment target
- 1
- Study location
Study Summary
This pilot research trial studies the antibody response to high-dose seasonal influenza vaccination in patients with myeloid malignancy receiving chemotherapy and healthy volunteers. Evaluating antibody response to high-dose seasonal influenza vaccine may serve as a basis for vaccine recommendations in patients with myeloid malignancies and provide insights into the status of the immune system in these patients.
Primary Outcome
The geometric mean (GMT) and standard deviation of antibody titers will be calculated by cohort at the baseline assessment and 1-3 months post vaccination time points. Antibody response is assessed using the outcome measures: seroprotection, seroconversion, and GMT. Seroprotection is defined as an hemagglutination inhibition (HAI) titer \>= 1:40 of each individual influenza antigen. Seroconversion is defined as \>= 4-fold increase in post-vaccination titer of each individual influenza antigen. T
Conditions Studied
Interventions
- BIOLOGICAL Trivalent Influenza Vaccine
Study Locations (1)
New York
- Roswell Park Cancer Institute - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2017-10-17 |
| Est. Completion | 2022-06-07 |
| Phase | Early Phase 1 |
What the finished NCT04484532 record still lists
NCT04484532 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (13% higher).
The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Trivalent Influenza Vaccine is the first listed.
NCT04484532 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04484532 about?
NCT04484532 is a clinical study titled "Evaluation of Antibody Response to High-Dose Seasonal Influenza Vaccination in Patients With Myeloid Malignancy Receiving Chemotherapy and Healthy Volunteers". This pilot research trial studies the antibody response to high-dose seasonal influenza vaccination in patients with myeloid malignancy receiving chemotherapy and healthy volunteers. Evaluating antibody response to high-dose seasonal influenza vaccine may serve as a basis for vaccine recommendations...
What is the current status of trial NCT04484532?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 130 participants. The study started on 2017-10-17. Estimated completion is 2022-06-07.
What conditions does trial NCT04484532 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome.
What interventions are being tested in trial NCT04484532?
The interventions under investigation include: Trivalent Influenza Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04484532?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04484532 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04484532's enrollment target sits among peer trials
130 62nd of 306 higher than 244 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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