EUCTR2008-000678-19-DE进行中（未招募）不适用
Feasibility and efficacy of Lenalidomide maintenance after salvage immuno-chemotherapy induction in relapsed or refractory mantle cell lymphoma - a phase II study of the European MCL Network
Klinikum der Universität München, Klinikum Großhadern0 个研究点目标入组 60 人开始时间: 2009年9月17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
- 60
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
- •1. Histologically confirmed, refractory or relapsed mantle cell lymphoma according to the World Health Organization (WHO) classification
- •2. Histological material available for reference pathology
- •3. Relapse or progression following at least one adequate prior line of anti-neoplastic therapy
- •4. Complete or partial remission after salvage induction of 3-4 courses R-FC(M), R-B(M), or 4-6 cycles R- CHOP
- •5. Prior high-dose chemotherapy treatment with autologous stem cell transplantation (at least 6 months ago) or not eligible for a high dose approach
- •6. Age >= 18 years at the time of signing the informed consent form
- •7. Written informed consent
- •8. ECOG performance status of <= 2 at study entry (see Appendix I)
- •9. Able to adhere to the study visit schedule and other protocol requirements
- •10. Laboratory test results within these ranges:
- •Absolute neutrophil count >=1.5 x 109/L
- •Platelet count >= 100 x 109/L
- •Serum Creatinine < 2.0 mg/dL
- •Total serum bilirubin <= 2.0 mg/dL
- •AST (SGOT) and ALT (SGPT) <=3 x ULN
- •11. Female subjects of childbearing† potential must:
- •oUnderstand the study drug is expected to have a teratogenic risk
- •oAgree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout the entire duration of 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.
- •oUnderstand that even if she has amenorrhea, she must follow all the advice on effective contraception.
- •oShe understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy
- •oAgree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml on the day of the study visit or in the 3 days prior to the study visit 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. The test should ensure the subject is not pregnant when she starts treatment
- •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 pregnancy tests should be performed on the day of the study visit or in the 3 days prior to the study visit.. This requirement also applies to women of childbearing potential who practice complete and continued abstinence
- •† Definition: see section 8.1 of trial protocol
- •12. Male subjects must
- •oAgree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study drug 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.
- •13. All subjects must
- •oAgree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
- •oAgree not to share study drug with another person and to return all unused study drug to the investigator or pharmacist.
- •14. Disease free of other malignancies for more than or equal to 3 years with exception of basal cell carcinoma of the skin, incidental histological finding of prostate cancer (TNM stage of T1a or T1b) or cervical cancer in si
排除标准
- •1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
- •2. Pregnant or breast feeding females. Lactating females must agree not to breast feed while taking lenalidomide.
- •3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- •4. Use of any other experimental drug or therapy within 28 days of begin of maintenance therapy or during study participation
- •5. Known hypersensitivity to thalidomide
- •6. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
- •7. Any prior use of lenalidomide
- •8. Concurrent use of other anti-cancer agents or treatments
- •9. Known HIV or active hepatitis infection, type A, B or C
- •10. Known acute thrombosis
- •11. CNS involvement of MCL
- •12. Biologic or immunotherapy (interferon, IL-2, B-cell specific antibodies etc.) less than 4 weeks prior to entry on this study or persistent toxic side effects of such therapy
- •13. Known thrombophilia
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