PEG IFN-alpha2a (Pegasys®) Therapy in Patients With Chronic Myeloproliferative Diseases (Excluding Philadelphia Chromosome Positive Chronic Myeloid Leukemia)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Number of Patients With Complete Response (CR) or Partial Response (PR)
研究概览
简要总结
The goal of this clinical research study is to see if Pegasys (IFN-alpha2a) can help to control the disease in patients with ET, PV, AMM/MF, and Ph-negative CML. The safety of this treatment will also be studied.
详细描述
IFN-alpha2a has been used for the treatment of a variety of disorders (such as hepatitis C). IFN-alpha2a is a drug that may affect the way infections and malignant diseases develop.
Before treatment starts, you will have blood (around 2 teaspoons) and bone marrow samples collected. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. These samples will be used for tests to confirm the diagnosis of the disease. Women who are able to have children must have a negative blood pregnancy test.
During treatment, you will receive IFN-alpha2a as an injection under the skin once a week. You (or your caregiver) will be taught how to give the injections, and you will receive treatment on an outpatient basis.
Treatment will continue (injections once a week) as long as the disease does not get worse.
If the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Following diagnoses: --ET: Patients with PLT > 600 x10 9 /l documented in the past 12 months; hyperplasia of marrow megakaryocytes in the absence of identifiable cause of thrombocytosis and in the absence of Ph chromosome. Patients with ET and lower PLT will be eligible if attributable to prior ET therapy. --PV: Patients should have Hb >/= 15g/dl (except if patient is having phlebotomies done) and documented past diagnosis.
- •Performance status </= 2 (ECOG scale).
- •Age greater than 18 years since disease is extremely rare in younger age group.
- •Adequate liver function: total bilirubin of </= 2.0 mg/dl (except for patients with Gilbert's Syndrome) and AST (SGOT) or ALT (SGPT) < 3 X ULN (or < 5 X ULN if considered due to tumor), and renal function (serum creatinine </= 2.0 mg/dl).
- •Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of the M.D. Anderson Cancer Center. The only acceptable consent form is the one approved by the M.D. Anderson Cancer Center IRB.
- •Willingness and ability to comply with the requirements of the protocol for the duration of the study.
- •Patients must have been off chemotherapy for 1 week prior to beginning Pegasys and have recovered from the toxic effects of that therapy. Patients may have received hydroxyurea or anagrelide immediately before study entry, and may continue into therapy if treating physician determines this is in the best interest of the patient.
排除标准
- •Pregnant or lactating women.
- •Patients with prior history of another malignancy or concurrent malignancy, except for the following: basal cell carcinoma of the skin, carcinoma in situ of the cervix, or other malignancies if the patient is disease free >3 years.
- •Patients with history of ischemic retinopathy.
- •Patients with history of severe cardiac disease: NYHA Functional Class III or IV, myocardial infarction within 6 months, uncontrolled ventricular tachyarrhythmias or unstable angina.
- •Patients with history of medically significant psychiatric disease if not controlled, especially endogenous depression (does not include reactive depression post-cancer diagnosis), psychosis and bipolar disease.
- •Patients with seizure disorders requiring anticonvulsant therapy.
- •Patients with known infection with HBV, HIV, or other active systemic infection.
- •Patients with known autoimmune disease except for rheumatoid arthritis.
- •Patients with renal disease on hemodialysis.
- •Patients taking continuous or chronic high-dose systemic steroids; if discontinued, there must be a minimum washout period of one month before study drug is begun.
- •Patients with known hypersensitivity to PEG-IFN alpha-2a or its components.
研究组 & 干预措施
IFN-alpha2a 90 Microgram (mcg) weekly
Starting dose 90 microgram (mcg) injection under the skin once a week.
干预措施: IFN-alpha2a (Drug)
IFN-alpha2a 450 Microgram (mcg) weekly
Starting dose 450 microgram (mcg) injection under the skin once a week.
干预措施: IFN-alpha2a (Drug)
IFN-alpha2a 360 Microgram (mcg) weekly
Starting dose 360 microgram (mcg) injection under the skin once a week.
干预措施: IFN-alpha2a (Drug)
IFN-alpha2a 270 Microgram (mcg) weekly
Starting dose 270 microgram (mcg) injection under the skin once a week.
干预措施: IFN-alpha2a (Drug)
IFN-alpha2a 180 Microgram (mcg) weekly
Starting dose 180 microgram (mcg) injection under the skin once a week.
干预措施: IFN-alpha2a (Drug)
结局指标
主要结局
Number of Patients With Complete Response (CR) or Partial Response (PR)
时间窗: Up to 18 years
CR = Reduction of PLT to \<440x109/l and disappearance of thromboembolic events, without the use of anagrelide or hydroxyurea PR = Reduction of PLT by 50% but still \>440x109/l or reduction of thromboembolic events by 50%, without the use of anagrelide or hydroxyurea
次要结局
未报告次要终点