Subcutaneous Rituximab and Intravenous Bendamustine in very Elderly Patients or Elderly Medically Non Fit Patients(slow go) with Aggressive CD-20-positive B-cell Lymphoma Short tiltle: BRENDA - BRENDA

niversity Medicine Göttingen Dept. Hematology and Oncology0 个研究点目标入组 68 人开始时间: 2011年10月19日最近更新: 2021年3月22日

适应症

试验速览

暂无简介。

•Histologically confirmed CD20 positive aggressive lymphoma,
•Aany stage according to Ann Arbor Classification,
•Any IPI score,
•Life expectancy of at least 6 week at study beginn
•Age = 81 (completed) or age 61 to 80 (completed, including time period until the day before the 81st birthday) and CIRS > 6 and not qualifying for CHOP-therapy
•Ability to give informed consent
•Written informed consent
•ECOG <4 determined during prephase treatment before the first rituximab application
•gender: any
•Contract of participation signed by the study centre and sponsor
•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 27
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•Already initiated lymphoma therapy (except for the prephase treatment up to the first Rituximab application as specified for this study)
•Serious accompanying disorder or impaired organ function (except when due to lymphoma involvement), in particular:
•angina pectoris CCS >2, cardiac failure NYHA >3
•FeV1<50% and/or a diffusion capacity <50% of the reference values
•creatinin clearance < 10 ml/min (Cockcroft-Gault)
•total bilirubin > 3 mg/dl
•Uncontrollable diabetes mellitus (prephase treatment with prednisolone!)
•Platelets <100 000/mm3, leukocytes <2500/mm3 (if not due to lymphoma)
•Known hypersensitivity to the medications to be used
•HIV-positivity
•Acute or chronic active hepatitis
•Poor patient compliance
•Simultaneous participation in other treatment studies
•Prior chemo- or radiotherapy, long-term use of systemic corticosteroids or anti-neoplastic drugs for previous disorder
•Other concomitant tumour disease and/or tumour disease in the past 5 years (except basalioma of the skin and carcinoma in situ)
•CNS involvement of lymphoma (intracerebral, meningeal, intraspinal)
•Active serious infections not controlled by oral or intravenous antibiotics or anti-fungal
•Any medical condition which in the opinion of the investigator places the subject at an unacceptably high risk.
•Non-conformity to eligibility criteria.

发起方

niversity Medicine Göttingen Dept. Hematology and Oncology