EUCTR2011-005818-10-AT进行中（未招募）不适用
PHASE II TRIAL OF RITUXIMAB (MABTHERA®) PLUS LENALIDOMIDE (REVLIMID®) IN PATIENTS WITH LYMPHOMA OF THE MUCOSA ASSOCIATED LYMPHOID TISSUE (MALT) - AGMT_MALT-2
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •For inclusion in the study, all of the following inclusion criteria must be fulfilled:
- •Patient understands and voluntarily signs the informed consent prior to any study
- •related assessments/procedures
- •Male or female = 18 years of age
- •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 with gastric MALT-lymphoma 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 ultimately serology) may be enrolled immediately)
- •Ann Arbor Stage I-IV
- •In case of prior treatment with Rituximab, the presence of CD20 on lymphoma cells
- •must have been demonstrated before inclusion in the trial.
- •ECOG performance status of 0,1 or 2
- •Age > 18 years
- •Life expectancy of at least 3 months
- •Patient must be able to take aspirin daily as prophylactic anticoagulation (patients intolerant to ASA (may use warfarin or low molecular weight heparin)
- •Hematological test results within these ranges:
- •Absolute neutrophil count equal/higher than 1000/µl
- •Platelet count egaul/higher 60 x 109/L
- •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:
- •understand the potential teratogenic risk to the unborn child
- •agree to have a medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/mL (including females of childbearing potential who commit to complete abstinence) details see appendix 6
- •agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; 3) dose interruptions; and 4) for at least 28 days after study treatment discontinuation.
- •The two methods of reliable contraception must include one highly effective method and one additional effective (barrier) method. FCBP must be referred to a qualified provider of contraceptive methods if needed. The following are examples of highly effective and additional effective methods of contraception:
- •Highly effective methods:
- •Intrauterine device (IUD)
- •Hormonal (birth control pills, injections, implants)
- •Tubal ligation
- •Partner’s vasectomy
- •Additional effective methods:
- •Male condom
- •Cervical Cap
- •Implants and levonorgestrel-releasing intrauterine systems are associated with an increased risk of infection at the time of insertion and irregular vaginal bleeding. Prophylactic antibiotics should be considered particularly in patients with neutropenia.
- •be informed and understand the potential consequences of pregnancy and the need to notify her study doctor immediately if there is a risk of pregnancy
- •understand the need to commence the study treatment as soon as study drug is dispensed following a negative pregnancy test
- •understand the need and accepts to undergo
排除标准
- •No patient may be included into the study if she/he fulfills any of the following criteria:
- •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
- •Known hypersensitivity to thalidomide or lenalidomide or rituximab
研究者
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