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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00962715
Recruitment Status : Withdrawn
First Posted : August 20, 2009
Last Update Posted : August 3, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical study is to learn if Pegasys (pegylated interferon) or Roferon (interferon) can make the Trivalent Inactivated Influenza vaccine (TIV) more effective in increasing the body's immune reaction against the flu virus in patients with Chronic Lymphocytic Leukemia (CLL).

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Biological: Influenza Vaccine Trivalent Inactivated (TIV) Drug: Pegylated interferon (PEGrIFN-α, Pegasys) Drug: Interferon (IFNα, Roferon-A) Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Phase I/II Clinical Trial Evaluating the Safety, Reactogenicity, and Immunogenicity of Licensed Trivalent Influenza Vaccine Administered With Recombinant Interferon Alpha Among Patients With Chronic Lymphocytic Leukemia
Study Start Date : April 2011

Arm Intervention/treatment
Experimental: TIV
TIV (Influenza Vaccine Trivalent Inactivated) alone
Biological: Influenza Vaccine Trivalent Inactivated (TIV)
15 μg (0.5 ml) through needle into arm muscle on Days 1 and 28.
Experimental: TIV + PEGrIFN-α
TIV + Pegylated Interferon
Biological: Influenza Vaccine Trivalent Inactivated (TIV)
15 μg (0.5 ml) through needle into arm muscle on Days 1 and 28.
Drug: Pegylated interferon (PEGrIFN-α, Pegasys)
180 μg (0.5 ml) before receiving TIV, through a needle under the skin.
Other Names:
  • Pegasys
  • Peginterferon alfa-2a
Experimental: TIV + IFNα
TIV + Interferon
Biological: Influenza Vaccine Trivalent Inactivated (TIV)
15 μg (0.5 ml) through needle into arm muscle on Days 1 and 28.
Drug: Interferon (IFNα, Roferon-A)
3 million units (0.5 ml) before receiving TIV, through a needle under the skin.
Other Names:
  • Roferon-A
  • Interferon alfa-2a

Primary Outcome Measures :
  1. Immunogenicity rate [ Time Frame: Day 1, 8, 28, 56 and 6 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00962715

Sponsors and Collaborators
M.D. Anderson Cancer Center
Study Chair: Amar Safdar, MD UT MD Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00962715     History of Changes
Other Study ID Numbers: 2007-0145
First Posted: August 20, 2009    Key Record Dates
Last Update Posted: August 3, 2012
Last Verified: August 2012

Keywords provided by M.D. Anderson Cancer Center:
Influenza Vaccine Trivalent Inactivated
Pegylated interferon

Additional relevant MeSH terms:
Influenza, Human
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Peginterferon alfa-2a
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents