Evaluation of Lenalidomide (CC-5013) and Prednisone as a Therapy for Patients With Myelofibrosis (MF)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Patients With Objective Response (Complete and Partial Response + Hematological Improvement)
研究概览
简要总结
The goal of this clinical research study is to learn if lenalidomide in combination with prednisone can help to control myelofibrosis. The safety of lenalidomide and prednisone for the treatment of myelofibrosis will also be studied.
详细描述
Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may decrease or prevent the growth of cancer cells. Prednisone is designed to improve the results of lenalidomide and to help reduce the side effects.
If you are found to be eligible to take part in this study, you will take 1-2 capsules of lenalidomide by mouth daily. You will take lenalidomide daily for 21 days followed by 1 week rest. This 28-day period is called a study "cycle."
Swallow lenalidomide capsules whole with water at the same time each day. Do not break, chew or open the capsules.
If you miss a dose of lenalidomide, take it as soon as you remember on the same day. If you miss taking your dose for the entire day, take your regular dose the next scheduled day (do NOT take double your regular dose to make up for the missed dose).
You will take prednisone by mouth every day during Cycles 1-2, and every other day during Cycle 3. You may only take prednisone for Cycles 1-3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Diagnosis of myelofibrosis requiring therapy, including those previously treated and relapsed or refractory, or if newly diagnosed, with intermediate or high risk according to Lille scoring system (risk factors are: Hb < 10 g/dl, White blood count (WBC) < 4 or > 30 x 109/L; risk group: 0 factor(s) = low, 1 factor(s) = intermediate, 2 factor(s) = high) or with symptomatic splenomegaly
- •Understanding and voluntary signing an Institutional Review Board (IRB)-approved informed consent form.
- •Age >/= 18 years at the time of signing the informed consent.
- •Disease-free of prior malignancies for >/= 2-years with exception of basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to
- •Patients must have adequate organ function as demonstrated by the following: Total bilirubin </= 2.0 mg/dL (unless higher due to MF); Serum creatinine </= 2.0 mg/dL (unless higher due to MF); Absolute neutrophil count >/= 1 x 10^9/L; Alanine transaminase (ALT) </= 3 x upper limit of normal (unless higher due to MF).
- •Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing.
- •Continuation of
- •Men must agree to use a condom during sexual contact with a female of child bearing potential even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See Appendix J: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods
- •footnote to no
- •† A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- •All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
排除标准
- •Use of any other standard (e.g. hydroxyurea, anagrelide, growth factors) or experimental drug or therapy within 28 days of starting lenalidomide and/or lack of recovery from all toxicity from previous therapy to grade 1 or better.
- •Known prior clinically relevant hypersensitivity reaction to thalidomide, including the development of erythema nodosum if characterized by a desquamating rash.
- •Prior therapy with lenalidomide.
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- •Suspected Pregnancy. Pregnant or lactating females.
- •Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- •Known positive for HIV or infectious hepatitis, type A, B or C.
- •Known prior clinically relevant hypersensitivity to prednisone.
- •Participants with a heart rate (HR) of less than or equal to 50, as a HR less than 50 indicates underlying cardiac abnormalities.
- •Participants with prior history of thromboembolic disease (i.e.-deep venous thrombosis (DVT) or pulmonary embolism (PE)) within the last six months, as Lenalidomide has demonstrated a significantly increased risk of DVT or PE.
研究组 & 干预措施
Lenalidomide + Prednisone
Lenalidomide oral 10 mg daily/days 1-21 of 28 day cycle. Prednisone starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.
干预措施: Lenalidomide (Drug)
Lenalidomide + Prednisone
Lenalidomide oral 10 mg daily/days 1-21 of 28 day cycle. Prednisone starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued.
干预措施: Prednisone (Drug)
结局指标
主要结局
Number of Patients With Objective Response (Complete and Partial Response + Hematological Improvement)
时间窗: 6 months
Time to response defined as the time from start of therapy until the response criteria are fulfilled. Response duration defined as the time from response until relapse (progressive disease) or death.
次要结局
未报告次要终点