EUCTR2009-010947-15-AT进行中（未招募）不适用
PHASE II TRIAL OF LENALIDOMIDE (REVLIMID®) IN PATIENTS WITH LYMPHOMA OF THE MUCOSA ASSOCIATED LYMPHOID TISSUE (MALT)
MUW, Klinik für Innere Med. I, Onkologie0 个研究点目标入组 16 人开始时间: 2009年4月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histologically verified diagnosis of MALT lymphoma of any localization
- •Measurable disease upon diagnosis or first or greater relapse after local therapy (including gastrectomy or any type of surgery or radiation), prior chemotherapy or HP-eradication. In addition, also patients judged refractory to HP-eradication by a minimum follow-up of 12 months after successful HP-eradication will be included in the study. Patients with gastric MALT lymphoma and no evidence of HP-infection (as judged by histology and ultimalely serology) may be enrolled immediately.
- •Measurable disease
- •Ann Arbor Stage I-IV
- •ECOG performance status of 0,1 or 2 (see Appendix )
- •Age between 18 and 80 years
- •Life expectancy of at least 3 months
- •Adequate cardiac, renal and liver function tests (LVEF > 50%, serum creatinine < 2.5 mg/dl, ALAT or ASAT < 2.5 x upper limit of normal range, alkaline phosphatase < 2.5 x upper limit of normal range, serum bilirubin < 2.0 mg/dl)
- •Patient must be willing and able to comply with the protocol for the entire study duration
- •Female subjects of childbearing potential† must:
- •oUnderstand that the study medication could have an expected teratogenic risk
- •oAgree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhoea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception*
- •?Implant**
- •?Levonorgestrel-releasing intrauterine system (IUS)**
- •?Medroxyprogesterone acetate depot
- •?Tubal sterilisation
- •?Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses
- •?Ovulation inhibitory progesterone-only pills (i.e., desogestrel)
- •* Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of VTE continues for 4 to 6 weeks after stopping combined oral contraception.
- •**prophylactic antibiotics should be considered at the time of insertion particularly in patients with neutropenia due to risk of infection
- •oAgree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml not more than 3 days before the start of study medication once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
- •oAgree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start of next treatment. This requirement also applies to women of childbearing potential who practice complete and continued abstinence
- •Male subjects must
- •oAgree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy if their partner is of childbearing potential and has no contraception.
- •oAgree not to donate semen during study drug therapy and for one week after end of study drug therapy.
- •All subjects must
- •oAgree to abstain from donating blood while taking study drug therapy and for one week following discontinuation o
排除标准
- •Lymphoma histology other than MALT lymphoma or MALT lymphoma with a diffuse large cell lymphoma (high grade lymphoma”) - component
- •Use of any investigational agent within 28 days prior to initiation of treatment with lenalidomide
- •History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years
- •Major surgery, other than diagnostic surgery, within the last 4 weeks
- •Evidence of CNS involvement
- •A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
- •Severe peripheral polyneuropathy
- •Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months
- •Inadequate hematological status at baseline prior to study entry: Dependency on red blood cell and/or platelet transfusions, ANC (absolute neutrophil count (segmented + bands)) <1.0 x 109/L
- •Patients with active opportunistic infections
- •Uncontrolled diabetes mellitus
- •Preexisting thromboembolic events at start of study
研究者
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