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.
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.
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
- 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
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.
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Day 1, 8, 28, 56 and 6 Months
Amar Safdar, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board