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Cancer Vaccine

Trivalent Influenza Vaccine for Acute Myeloid Leukemia

Phase < 1
Waitlist Available
Led By Elizabeth A Griffiths
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4-6 months post-vaccination
Awards & highlights

Study Summary

This trial looks at how well the flu vaccine works in people with myeloid cancer.

Eligible Conditions
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4-6 months post-vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4-6 months post-vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Antibody response (by microneutralization assay) to influenza vaccination
Secondary outcome measures
T-cell subset population assessed using flow cytometry

Side effects data

From 2013 Phase 4 trial • 300 Patients • NCT01859143
7%
Nasal congestion
2%
Sinus congestion
1%
Upper respiratory tract infection
1%
Sneezing
1%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
TRIVALENT VACCINE
PLACEBO

Trial Design

1Treatment groups
Experimental Treatment
Group I: Supportive Care (trivalent influenza vaccine)Experimental Treatment1 Intervention
Within 14 days of baseline influenza titer, patients receive trivalent influenza vaccine IM on day 0 (patients in cohorts 1 and 5 receive the vaccine at any time, patients in cohorts 2 and 3 receive the vaccine between days 14-25 of hypomethylating agent therapy course, and patients in cohort 4 receive the vaccine between days 21-365 from onset of cytotoxic chemotherapy). Patients then undergo titer assessment at days 25-90 and days 115-185.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trivalent Influenza Vaccine
2010
Completed Phase 4
~2630

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,728 Total Patients Enrolled
Elizabeth A GriffithsPrincipal InvestigatorRoswell Park Cancer Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this the pioneering research of its type?

"Currently, 16 live trials are underway for the Trivalent Influenza Vaccine across 10 cities and 4 nations. The inaugural clinical trial was completed in 2015 by Green Cross Corporation with a cohort of 1,630 patients that successfully passed Phase 3 drug approval. Since then, 312 similar studies have been performed."

Answered by AI

How many people are eligible to partake in this clinical experiment?

"Affirmative. The information available on clinicaltrials.gov confirms that recruitment for this trial is currently underway, with 200 volunteers being sought from a single primary location since the initial post date of October 17th 2017 and most recent update on April 13th 2022."

Answered by AI

Are there any openings for individuals to participate in this trial?

"Verified, the online repository at clinicaltrials.gov states that this medical experiment is in progress and recruiting patients. The trial was initially advertised on October 17th 2017, with a latest update appearing on April 13th 2022. 200 participants are required for 1 particular location."

Answered by AI
~17 spots leftby Apr 2025