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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00962715
First received: August 19, 2009
Last updated: August 2, 2012
Last verified: August 2012
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Immunogenicity rate [ Time Frame: Day 1, 8, 28, 56 and 6 Months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: April 2011
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962715

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00962715     History of Changes
Other Study ID Numbers: 2007-0145
Study First Received: August 19, 2009
Last Updated: August 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Leukemia
CLL
Influenza Vaccine Trivalent Inactivated
TIV
Flu
Pegasys
Pegylated interferon
Roferon
Interferon

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Interferons
Interferon-alpha
Peginterferon alfa-2a
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014