Reactogenicity, Immunogenicity of Trivalent Influenza Vaccine With Recombinant Interferon Alpha Among Chronic Lymphocytic Leukemia
|First Submitted Date ICMJE||August 19, 2009|
|First Posted Date ICMJE||August 20, 2009|
|Last Update Posted Date||August 3, 2012|
|Start Date ICMJE||April 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Immunogenicity rate [ Time Frame: Day 1, 8, 28, 56 and 6 Months ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00962715 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Reactogenicity, Immunogenicity of Trivalent Influenza Vaccine With Recombinant Interferon Alpha Among Chronic Lymphocytic Leukemia|
|Official Title ICMJE||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|
|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).|
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Chronic Lymphocytic Leukemia|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Withdrawn|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Not Provided|
|Removed Location Countries||United States|
|NCT Number ICMJE||NCT00962715|
|Other Study ID Numbers ICMJE||2007-0145|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||M.D. Anderson Cancer Center|
|Study Sponsor ICMJE||M.D. Anderson Cancer Center|
|Collaborators ICMJE||Not Provided|
|PRS Account||M.D. Anderson Cancer Center|
|Verification Date||August 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP