Influenza Vaccination in Patients Receiving Antineoplastic Therapy for Non-Hodgkin's Lymphoma

Completed · Phase 2

Conditions studied: Lymphoma

In brief

Primary Objective: To assess the trend in immunogenic response across patients administered either licensed trivalent inactivated influenza vaccine (TIV) or one of three doses (15, 45 or 135 μg) of trivalent recombinant baculovirus expressed hemagglutinin vaccines. Immunogenic response is defined as a 4-fold or greater increase in serum antibody. Secondary Objective: To determine the safety and tolerability of 3 doses (15 μg HA per virus, 45 μg HA per virus, and 135 μg HA per virus) of recombinant baculovirus-expressed HA vaccine in patients with non-Hodgkin's B-cell lymphoma.

Key facts

Study ID

NCT00307710

Run by

M.D. Anderson Cancer Center

People needed

28

Starts

2004-08-01

Expected to finish

2007-02-01

Last updated by the study team

2012-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with non-Hodgkin's B-cell lymphoma (NHL) including follicular, large cell and Mantle cell lymphoma will be included.
• Patients in complete clinical remission and determined to have no evidence of active disease (NED).
• Patients greater than or equal to 18 years of age who have given informed consent and signed the IRB approved informed consent.
• Ambulatory, medically stable persons; community dwelling; able to give informed consent and available for all study visits; able to understand and comply with planned study procedures; ECOG performance status of less than or equal to 2.
• Medically stable subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, but their symptoms/signs are controlled with medical therapy.
• Patients with a non-metastatic secondary solid tumor or malignancies not currently (< 3 months) being treated will be included.

You may not qualify if…

• Patients with Hodgkin's disease, and T-cell lymphoma.
• Patients undergoing antineoplastic therapy.
• Patients who have received chemotherapy within the past 3 months.
• Individuals who were given rituximab (ibritumomab tiuxetan) in < 6 months.
• Patients receiving systemic corticosteroids and/or high-dose inhaled steroids (>800 mcg per day of beclomethasone dipropionate or equivalent).
• Splenectomized individuals will not be included.
• Known allergy to eggs or other components of vaccine (e.g., thimerosal).
• Acute or chronic condition that (in the opinion of the investigator) would render vaccination unsafe or would interfere with the evaluation of responses (including but not limited to the following: acute febrile illness, known chronic liver disease; significant renal disease; oxygen-dependent chronic lung disease, New York Heart Association Functional Class III or IV dyspnea; unstable or progressive neurologic disorder; insulin-dependent diabetes mellitus).
• Concomitant use of investigational vaccines and/or other medications within 4 weeks prior to study entry, or expected use of experimental or licensed vaccines or blood/blood products prior to study completion.
• Previous exposure to parenteral immunoglobulins or other blood product within 6 months prior to enrollment into the study.
• Subject is enrolled in a conflicting clinical trial.
• Use of experimental vaccines or medications within one month of study entry.
• Any acute or chronic condition which in the opinion of the investigator would render vaccination unsafe or interfere with the evaluation of response.
• Patients with a known history or risk factors (IV drug abuse or casual sex within the past year) of Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus.

Where it is running

• U.T.M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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