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
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Immunogenicity rate
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of understanding the protocol requirements and risks and providing written informed consent.
- •Patients with histologically or cytologically confirmed diagnosis of chronic lymphocytic leukemia according to established guidelines.
- •Patients with Rai stages 0 to
- •Age >/= 18 years old.
- •If patients have been treated with antineoplastic therapy, it must have been finished 3 months or longer prior to enrollment.
- •Patients with complete or partial remission and those with stable (CLL) disease will be considered.
- •Patients who have received influenza vaccine in past 4 months will also be considered.
- •Patients willing to receive recombinant cytokine.
- •Patient willing to receive commercially available influenza vaccine that will not provide protection against the following years of influenza strains.
- •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.
- •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.
- •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.
排除标准
- •Concurrent serious medical illness in the opinion of Principle Investigator that could potentially interfere with protocol compliance.
- •Concurrent or previous malignancy whose prognosis is poor (< 90% probability of survival is 5 years).
- •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.
- •Positive screening pregnancy test within 2 weeks in non-menopausal women or breast-feeding.
- •Patients with known allergy to either vaccine or interferon preparation.
- •Patients with neutropenia (ANC < 500 cells/uL) within 4 weeks.
- •Patients with lymphocytopenia (ALC < 300 cells/uL) within 4 weeks.
- •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.
- •Receipt of immunoglobulin in 3 months.
- •Subject is enrolled in a conflicting clinical trial.
- •History of Guillain-Barre Syndrome.
- •Has an acute illness including an oral temperature greater than 100.4°F, within one week of vaccination.
- •In patients who have prior therapy with fludarabine or alemtuzumab (Campath®), the treatment must have completed 12 months prior to enrollment.
- •In patients who have prior therapy with Rituximab (Rituxan®), the treatment must have completed 6 months prior to enrollment.
- •Patients with history of medically significant psychiatric disease, especially endogenous depression (not reactive to diagnosis of cancer), psychosis and bipolar disorder.
- •Patients with seizure disorders requiring anticonvulsant therapy.
- •Patients with history of severe cardiac disease with New York Heart Association (NYHA) grade 3 or
- •Patients with severe renal disease requiring hemodialysis.
- •Patients who have received H2 blockers such as Ranitidine, Cimetidine, or Famotidine within 4 weeks prior to enrollment.
研究组 & 干预措施
TIV
TIV (Influenza Vaccine Trivalent Inactivated) alone
干预措施: Influenza Vaccine Trivalent Inactivated (TIV) (Biological)
TIV + PEGrIFN-α
TIV + Pegylated Interferon
干预措施: Influenza Vaccine Trivalent Inactivated (TIV) (Biological)
TIV + PEGrIFN-α
TIV + Pegylated Interferon
干预措施: Pegylated interferon (PEGrIFN-α, Pegasys) (Drug)
TIV + IFNα
TIV + Interferon
干预措施: Influenza Vaccine Trivalent Inactivated (TIV) (Biological)
TIV + IFNα
TIV + Interferon
干预措施: Interferon (IFNα, Roferon-A) (Drug)
结局指标
主要结局
Immunogenicity rate
时间窗: Day 1, 8, 28, 56 and 6 Months
次要结局
未报告次要终点