EUCTR2007-000821-23-DK进行中（未招募）1 期
Alemtuzumab and Chemotherapyin T-cell-Lymphoma (ACT): CHOP-14 with or without the Monoclonal Anti-CD52 Antibody Alemtuzumab in Elderly Patients DSHNHL 2006-1B /ACT-2
Faculty of Medicine at the Georg-August University, Göttingen0 个研究点目标入组 274 人开始时间: 2007年6月18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
- 入组人数
- 274
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
- •. Age:61 - 80 years
- •2. Risk group:All risk groups, including stage I with bulk (= 7.5 cm) and stages II to IV, exept stage I with no further IPI risk factor (LDH, ECOG, stage, E>1) beside the age over 60
- •3. Histology:Diagnosis of aggressive non-Hodgkin's lymphoma, confirmed by an excisional biopsy of a lymph node or by a sufficiently extensive biopsy of an extranodal involvement if there is no lymph node involvement. It will be possible to treat all peripheral T-lineage lymphomas with the exception of ALK-positive anaplastic large cell lymphoma and primary cutaneous T-cell lymphomas (Mycosis fungoides, Sezary syndrome and primary cutaneous CD30-positive lymphoproliferations, and transformed primary cutaneous T-cell lymphomas). These lymphomas comprise:
- •T cell -NHL:
- •peripheral T-cell lymphoma PTCL-NOS
- •Lennert's lymphoma
- •T-zone lymphoma
- •T-cell lymphoma of the AILD type
- •anaplastic large cell lymphoma
- •extranodal NK/T-cell lymphoma, nasal type
- •intestinal T/NK-cell lymphoma (± enteropathy)
- •hepatosplenic gamma-delta lymphoma
- •subcutaneous panniculitis-like PTCL
- •4. Performance status:Performance status ECOG 0 - 2 (Karnofsky index: 60 - 100%). The general status of each patient is to be assessed at time of randomisation and can thus take place after initiation of prephase treatment. A performance status of ECOG 3 will allow inclusion, if it is lymphoma related. The pretreatment status is to be documented in the staging CRF; the performance after the prephase treatment is also to be documented in the relevant CRF for the prephase treatment (see Appendix). A definition of the performance status is provided in the Appendix.
- •5. Declaration of center participation
- •6. written consent of the patient
- •7. measurable diseasedefined as at least one lesion with two measurable perpendicular diameters of which at least one should be ³15 mm
- •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
- •Stage I with IPI 0 and without bulk
- •2.Already initiated lymphoma therapy (except for the prephase treatment specified for this study)
- •3.Serious accompanying disorder or impaired organ function, in particular:
- •-Cardiac: angina pectoris CCS >2, cardiac failure NYHA >2 and/or EF <45% or FS<25% in echocardiography/nuclear medicine examination
- •- Pulmonary: abnormal blood gases; in this case, the patient is to be excluded if the resultant pulmonary function test shows FeV1<50% or a diffusion capacity <50% of the reference values
- •-Renal: creatinine >2 times the upper reference limit, unless related to NHL
- •-Hepatic: bilirubin >2 times the upper reference limit, unless related to NHL
- •-Uncontrollable diabetes mellitus (prephase treatment with prednisone!)
- •4.Platelets <100 000/mm3, leukocytes <2500/mm3
- •5.Bone marrow involvement >25%
- •6.Primary leukemic manifestation of the lymphoma
- •7.Known hypersensitivity to the medications to be used, especially murine or chimeric antibodies
- •8.Known HIV-positivity
- •9.Active hepatitis infection, active CMV infection, active systemic fungal infection, active infection with mycobacterium tuberculosis or atypical tuberculosis
- •10.Suspicion that patient compliance will be poor
- •11.Simultaneous participation in any other study protocol
- •12.Prior chemo- or radiotherapy for malignancy
- •13.Other concomitant malignant disease (history of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma)
- •14.Non-conformity to eligibility criteria
研究者
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