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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia

Thank you

Trial Information

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


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 to be drawn. Women who are able to have children must have a negative
blood (about 1 teaspoon) blood test within 2 weeks of study entry.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the roll of dice) to 1 of 3 groups.

If you are assigned to Group 1, you will receive TIV alone. If you are assigned to Group 2,
you will receive pegylated interferon with TIV. If you are assigned to Group 3, you will
receive interferon with TIV.

You will have an equal chance of being assigned to any of the 3 groups. Your doctor, the
study doctor, study staff, and you will know which group you are in.

Study Drug Administration:

You will receive TIV through a needle into a muscle in your arm (the arm you do not write
with) on Days 1 and 28.

- If you are in Group 1, you will only receive TIV

- If you are in Group 2, you will receive pegylated interferon right before you receive
TIV. It will be given through a needle under the skin. It will be given near the TIV
injection site.

- If you are in Group 3, you will receive interferon right before you receive TIV. It
will be given through a needle under the skin. It will be given near the TIV injection
site.

After you are given the injection(s), you will be watched for 15 minutes in the clinic
before you are allowed to go home.

You will keep a diary for 1 week (7 days) after the injection(s). In it, you will record any
symptoms you may be experiencing, and you will also record your body temperature.

Study Visits:

On Day 1, blood (about 4 teaspoons) will be drawn to check your immune system's response to
the flu virus.

On Day 8, you will be asked to return to the clinic and your symptom/temperature diary will
be reviewed. If you cannot come to the clinic, a member of the research staff will call you
to review this information. This phone call will take 15-30 minutes.

On Day 28, blood (about 4 teaspoons) will be drawn to check your immune system response to
the flu virus.

On Day 56, blood (about 4 teaspoons) will be drawn to check you immune system response to
the flu virus. If you live out of town and cannot return to M. D. Anderson for this visit,
you may have your blood drawn at a local clinic. You will then mail the blood to the study
doctor in a pre-paid envelope.

On Month 6, you will be called and asked about any side effects you may have experienced.
This phone call will take 15-30 minutes.

Length of Study:

You will be considered off study after the Month 6 phone call. You will be taken off-study
early if intolerable side effects or an allergic reaction occurs.

This is an investigational study. TIV, pegylated interferon, and interferon are FDA
approved and commercially available. At this time, the use of pegylated interferon and
standard interferon with TIV is only being used for research.

Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.


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 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Immunogenicity rate

Outcome Time Frame:

Day 1, 8, 28, 56 and 6 Months

Safety Issue:

No

Principal Investigator

Amar Safdar, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2007-0145

NCT ID:

NCT00962715

Start Date:

April 2011

Completion Date:

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Leukemia
  • CLL
  • Influenza Vaccine Trivalent Inactivated
  • TIV
  • Flu
  • Pegasys
  • Pegylated interferon
  • Roferon
  • Interferon
  • Influenza, Human
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

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