EUCTR2009-014768-21-DE进行中（未招募）不适用
Treatment of MDS patients with single agent temsirolimus – a pilot study - TEMDS
Dresden Technical University0 个研究点开始时间: 2010年1月5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
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. Age greater/equal 18 years at the time of signing the informed consent form;
- •2. Cytologically or histologically established diagnosis of de novo or therapy-related MDS according to the FAB-classification, either previously treated or untreated, presenting with:
- •Group I (low-risk): Low- or INT-1 risk features according to IPSS and requiring at least 4 units of red blood cells within the last 8 weeks prior to study entry or presenting with neutropenia (<1 Gpt/l neutrophils)
- •Group II (high-risk): INT-2 or HIGH-risk IPSS refractory or intolerant to 5-Azacytidine.
- •CMML patients of dysplastic phenotype (WBC < 13 Gpt/l) may be included in both arms according to IPSS. CMML patients showing proliferative phenotype (WBC >=13 Gpt/l) will be included in the high risk arm.
- •3. Not eligible for an immediate allogeneic HSCT or conventional chemotherapy
- •4. All previous MDS specific therapies (except supportive approaches like transfusions or antibiotics) must have been discontinued at least 4 weeks prior to study enrollment.
- •5. ECOG performance status of <=3 at study entry (see Appendix 01).
- •6. laboratory test results within these ranges:
- •Serum creatinine <= 177 µmo/l (<= 2.0 mg/dL)
- •Total bilirubin <= 3 x ULN
- •AST (SGOT) and ALT (SGPT) <= 3 x ULN
- •Total fasting cholesterol <= 9.1 mmol/l (350 mg/dl)
- •Fasting triglyceride level <= 4.5 mmol/l (400 mg/dl)
- •Platelets > 25 Gpt/l without transfusion support in patients with LOW- and
- •INT- 1 Risk according to IPSS
- •7. 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 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. For Patients with LOW- or INT1-Risk according to IPSS: Thrombocytopenia below 25 Gpt/l (INT2- and HIGH-IPSS patients may be included irrespective of platelet count);
- •2. known hypersensitivity to temsirolimus, sirolimus or any components of the infusion solution (dl-alpha-tocopherol, propylene glycol, anhydrous citric acid, polysorbate 80, polyethylene glycol 400, dehydrated alcohol);
- •3. known hypersensitivity to macrolid antibiotics (because of structural similarities between this class of antibiotics and study medication);
- •4. 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;
- •5. known positive for HIV or any other uncontrolled infection;
- •6. presence of any other malignancy being not in complete remission for at least 3 years (previous chemotherapy for other malignancies is not an exclusion criteria);
- •7. necessity of therapeutic anticoagulation (excluding low dose ASS);
- •8. participation in an other clinical trial within the last 4 weeks;
- •9. pregnant or breastfeeding females (lactating females must agree not to breast feed while on study);
- •10. females of childbearing potential (FCBP) except those fulfilling the following criteria:
- •- post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea
- •with serum FSH > 40 U/ml);
- •- post-surgery (6 weeks after bilateral ovarectomy with or without hysterectomy);
- •- regular and correct use of contraceptives with a PEARL Index of < 1% (e.g.
- •implants, depot formulations of hormones, oral contraceptives, intra uterine
- •device – IUD);
- •- sexual abstinence;
- •- partner, who had vasectomy (confirmed by two negative analyses of semen);
- •11. male patients, who do not agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 3 months following discontinuation from the study even if he has undergone a successful vasectomy;
- •12. patients with a history of chronic drug abuse or another illness which does not allow the patient to assess the nature and/or possible consequences of the study;
- •13. patients who are not likely to follow the trial protocol (lack of willigness to cooperate).
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