EUCTR2009-014844-13-DE进行中（未招募）1 期
Phase I/II clinical trial with Bendamustine and Temsirolimus in patients with relapsed or refractory mantle cell lymphoma that are not eligible for high dose chemotherapy and stem cell transplantation. - Bendamustine and Temsirolimus in relapsed or refractory mantle cell lymphoma
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
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 = 18 years
- •2. Histologically proven mantle cell lymphoma
- •3. First or second relapse or progression during treatment. A prior treatment with bendamustine ist feasible, if the patient achieved at least a partial response and progression free survival lasted at least six months. A prior high dose chemotherapy with autologous stem cell transplantation is feasible, if the patient achieved at least a partial response and progression free survival lasted at least twelve months.
- •4. Patients are not eligible for high dose chemotherapy and autologous or allogenous stem cell transplantation.
- •5. Sufficient bone marrow reserve (hemoglobuline > 9 g/dL, thrombocytes > 100/nL, neutrophile granulocytes > 1.5/nL)
- •6. WHO/ECOG performance status 0 – 2
- •7. Measurable disease (two perpendicular diameters in radiologic evaluation)
- •8. Life expectancy of at least three months
- •9. Written 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
- •1. Prior treatment with an mTOR inhibitor
- •2. Severe concomitant disease (e.g. severe cardiac insufficiency, myocardial infarction within the last six months prior to inclusion into the clinical trial, uncontrolled arterial hypertension, renal failure requiring dialysis, severe lung disease, severe liver disease, severe diabetes mellitus)
- •3. Disturbed liver function: transaminases or total bilirubine > 2 x upper limit of normal
- •4. Disturbed kidney function: serum-creatinine > 2 x upper limit of normal
- •5. Coexistant or prior malignant tumor within the last three years with the exception of an adequately treated basal cell carcinoma or a cervical carcinoma in situ.
- •6. Concomitant treatment with strong inducers or inhibitors of CYP3A4
- •7. Women, pregnant or breast feeding, may not be included into the trial. The same applies for fertile patients, women and men alike, that are not willing to perform an efficient contraception. An effective contraception has a failure rate below 1% per year (e.g. sexual abstinence or vasectomy). Fertile women have to have a negative pregnancy test that is not older than seven days.
- •8. Bigger surgical procedures within the last four weeks prior to inclusion. Smaller surgical procedures (e.g. implantation of an i.v. portal catheter) within one week prior to inclusion.
- •9. Prior treatment in a clinical trial within the last four weeks prior to inclusion into the clinical trial.
- •10. Concomitant immunotherapy (e.g. Rituximab) or chemotherapy except bendamustine. The usage of systemic steroids should be documented and reported to the leading clinical trial center.
- •11. CNS-manifestation
- •12. HIV-positivity
- •13. Active or inactive hepatitis B or hepatitis C infection
- •14. Severe psychiatric disease
- •15. Individuals that are placed into an institution due to magisterial or judicical order
- •16. Incapacity to follow the protocol requirements
研究者
相似试验
进行中（未招募）
不适用
Multicentre phase II trial of Bendamustine in combination with rituximab for patients with previously untreated or relapsed chronic lymphocytic leukemia - CLL2Mpreviously untreated or relapsed chronic lymphocytic leukemiaEUCTR2005-001596-34-DEniversität zu Köln95
招募中
1 期
Phase 1/2 study of the combination of Bendamustine and Rituximab for treatment of relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphomaJPRN-UMIN000005428Department of Hematology, International Medical Center, Saitama Medical University40
招募中
1 期
Phase 1/2 study of the combination of Bendamustine and Rituximab for treatment of elderly relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.JPRN-UMIN000006513Kinki University School of Medecine Division of Hematology43
已完成
1 期
Bendamustine Hydrochloride, Rituximab, Etoposide, and Carboplatin in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma or Hodgkin LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Hodgkin LymphomaNCT01165112University of Washington48
进行中（未招募）
不适用
Phase II study of the combination Bendamustine and sc Alemtuzumab for patients with refractory or relapsed B-cell chronic lynphocytic leukemia - BEN-CAMEUCTR2008-001824-30-ITAssociazione Malattie Sangue Onlus