EUCTR2007-005116-12-DE进行中（未招募）1 期
Phase II study of the mTOR-Inhibitor EVEROLIMUS asmaintenance therapy in patients aged over 60 years with MantleCell Lymphoma (MCL) after first, second, third or fourth linechemotherapyNew title since Protocol Version 4.0Phase II study of the mTOR-Inhibitor EVEROLIMUS asmaintenance therapy in patients aged over 60 years with MantleCell Lymphoma (MCL) after first, second, third or fourth linechemotherapy - CRAD001C2428
Technical University of Munich0 个研究点目标入组 0 人开始时间: 2007年11月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •- Patients with a proven history of mantle cell lymphoma
- •2. Patients with achieved disease control after one to four lines
- •of chemotherapy (complete response, partial response, stable
- •disease) for mantle cell lymphoma.
- •3. Patients must have been treated with a CHOP-like
- •chemotherapy or a Fludarabine-containing regimen
- •previously and Rituximab must have been used as part of the
- •previous treatment.
- •4. Age = 60 years or patients =40 and <60 years of age who are
- •not eligible for high dose chemotherapy followed by
- •autologous stem cell support or allogeneic stem cell
- •transplantation.
- •5. Minimum of two weeks since any major surgery, completion
- •of radiation, or completion of all prior systemic anticancer
- •therapy (adequately recovered from the acute toxicities of
- •any prior therapy).
- •6. WHO performance status = 2
- •Adequate bone marrow function as shown by: ANC = 1.5 x
- •109/L, Platelets = 100 x 109/L, Hgb > 9 g/dL
- •8. Adequate liver function as shown by: serum bilirubin = 1.5 xupper limit of normal (ULN), and serum transaminases
- •activity = 3 x ULN. With the exception of serum
- •transaminases (< 5 x ULN) if the patient has liver metastases
- •9. Life expectancy of at least 3 months
- •10. Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Prior treatment with any investigational drug within the
- •preceding 4 weeks
- •2. Chronic treatment with systemic steroids or another
- •immunosuppressive agent except for Rituximab.
- •3. Uncontrolled brain or leptomeningeal disease manifestation,
- •including patients who continue to require glucocorticoids
- •for brain or leptomeningeal disease manifestation
- •4. Other malignancies within the past 3 years except for
- •adequately treated carcinoma of the cervix or basal or
- •squamous cell carcinomas of the skin.
- •5. Other concurrent severe and/or uncontrolled medical disease
- •which could compromise participation in the study (i.e.,
- •uncontrolled diabetes, uncontrolled hypertension, severe
- •infection, severe malnutrition, unstable angina, or congestive
- •heart failure - New York Heart Association Class III or IV,
- •ventricular arrhythmias active ischemic heart disease,
- •myocardial infarction within six months, chronic liver or
- •renal disease, active upper GI tract ulceration, psychiatric
- •6. A known history of HIV seropositivity
- •7. History or serology indicating active or chronic Hepatitis B
- •or C or detection of viral DNA (Hep. B or C) via PCR
- •8. Impairment of gastrointestinal function or gastrointestinal
- •disease that may significantly alter the absorption of
- •EVEROLIMUS (e.g., ulcerative disease, uncontrolled
- •nausea, vomiting, diarrhea, malabsorption syndrome or small
- •bowel resection)
- •9. Patients with an active, bleeding diathesis or on oral antivitamin
- •K medication (except low dose coumarin)
- •10. Previous organ transplantation.
- •11. Women who are pregnant or breast feeding, or women able
- •to conceive and unwilling to practice an effective method of
- •birth control. (Women of childbearing potential must have a
- •negative urine or serum pregnancy test within 7 days prior to
- •administration of EVEROLIMUS). Oral, implantable, orinjectable contraceptives may be affected by cytochrome
- •P450 interactions, and are therefore not considered effective
- •for this study. A highly effective methode of birth control is
- •defined as those which results in a low failure rate (i.e. less
- •than 1% per year) for example sexual abstinence or
- •vasectomised partner.
- •12. Patients who have received prior treatment with an mTor
- •13. History of noncompliance to medical regimens
- •14. Patients unwilling to or unable to comply with the protocol
- •15. Patients with galactose intolerance, lack of lactase or
- •malabsorption of glucose or galactose
研究者
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