Reactogenicity, Immunogenicity of Trivalent Influenza Vaccine With Recombinant Interferon Alpha Among Chronic Lymphocytic Leukemia

Launched by M.D. ANDERSON CANCER CENTER · Aug 19, 2009

Keywords

ClinConnect Summary

The Study Drugs:

Pegylated interferon and interferon are designed to stop the growth of viruses. Pegylated interferon has a molecule that makes it last longer in the body. Standard interferon does not have this molecule that makes it last longer.

TIV is designed to prevent the flu.

Screening Test:

Before you can start treatment on this study, you will have a "screening test" to help the doctor decide if you are eligible to take part in this study. Blood (about 4 teaspoons) will be drawn for routine tests. If you have had a routine blood test in the last 4 weeks, this blood will not need...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Capable of understanding the protocol requirements and risks and providing written informed consent.
• • 2. Patients with histologically or cytologically confirmed diagnosis of chronic lymphocytic leukemia according to established guidelines.
• • 3. Patients with Rai stages 0 to 4.
• • 4. Age \>/= 18 years old.
• • 5. If patients have been treated with antineoplastic therapy, it must have been finished 3 months or longer prior to enrollment.
• • 6. Patients with complete or partial remission and those with stable (CLL) disease will be considered.
• • 7. Patients who have received influenza vaccine in past 4 months will also be considered.
• • 8. Patients willing to receive recombinant cytokine.
• • 9. Patient willing to receive commercially available influenza vaccine that will not provide protection against the following years of influenza strains.
• • 10. Patients must have adequate hepatic function defined as follows: total bilirubin \</= 2.0 mg/dL; SGOT and /or SGPT \</= 3 x upper normal limit of the reference laboratory value unless liver function abnormalities are considered due to underlying cancer or congenital hemolytic disorders.
• • 11. Patient should avoid H2 blockers while on study. However, if H2 blockers are required to use, this will be reported and will be taken in consideration during response rate analysis.
• • 12. Females patients who are able to have children must agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control during the time period starting 2 weeks prior to enrollment through 1 month from last vaccination dose. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge and condom. If they suspect pregnancy during the study, they must notify the study doctor.
• Exclusion Criteria:
• • 1. Concurrent serious medical illness in the opinion of Principle Investigator that could potentially interfere with protocol compliance.
• • 2. Concurrent or previous malignancy whose prognosis is poor (\< 90% probability of survival is 5 years).
• • 3. History of known chronic viral infections within 12 months, including HIV and Hepatitis B or Hepatitis C. A screening for hepatitis or HIV will not be performed for this study.
• • 4. Positive screening pregnancy test within 2 weeks in non-menopausal women or breast-feeding.
• • 5. Patients with known allergy to either vaccine or interferon preparation.
• • 6. Patients with neutropenia (ANC \< 500 cells/uL) within 4 weeks.
• • 7. Patients with lymphocytopenia (ALC \< 300 cells/uL) within 4 weeks.
• • 8. Concomitant use of investigational vaccines and/or medications within four weeks prior to study entry, or expected use of experimental or licensed vaccines or blood/blood products prior to study completion.
• • 9. Receipt of immunoglobulin in 3 months.
• • 10. Subject is enrolled in a conflicting clinical trial.
• • 11. History of Guillain-Barre Syndrome.
• • 12. Has an acute illness including an oral temperature greater than 100.4°F, within one week of vaccination.
• • 13. In patients who have prior therapy with fludarabine or alemtuzumab (Campath®), the treatment must have completed 12 months prior to enrollment.
• • 14. In patients who have prior therapy with Rituximab (Rituxan®), the treatment must have completed 6 months prior to enrollment.
• • 15. Patients with history of medically significant psychiatric disease, especially endogenous depression (not reactive to diagnosis of cancer), psychosis and bipolar disorder.
• • 16. Patients with seizure disorders requiring anticonvulsant therapy.
• • 17. Patients with history of severe cardiac disease with New York Heart Association (NYHA) grade 3 or 4.
• • 18. Patients with severe renal disease requiring hemodialysis.
• • 19. Patients who have received H2 blockers such as Ranitidine, Cimetidine, or Famotidine within 4 weeks prior to enrollment.