Therapie des nodalen Follikulären Non-Hodgkin-Lymphoms (WHO Grad I/II) im klinischen Stadium I / II mittels involved-field Bestrahlung in Kombination mit Rituximab (Mabthera Involved-field Radiotherapy-Trial/ MIR)english translation:Therapy of the nodal follicular non-Hodgkin´s Lymphoma (WHO Grade I/II) in clinical stage I/II with involved field radiatherapy in combination with Rituximab (Mabthera Involved-field Radiotherapy-Trial/ MIR) - MIR

niversity Hospital of Heidelberg0 个研究点目标入组 85 人开始时间: 2007年5月9日最近更新: 2021年8月24日

试验速览

暂无简介。

•1. Histology: follicular lymphoma grade 1/2 according to WHO classification (2001);
•CD20 positivity
•2. Manifestation: untreated nodal lymphoma (including: manifestation in Waldeyer´s ring)
•3. Age: 18-75
•4. ECOG: 0 - 2
•5. Stage CS I and II (Ann Arbor classification)
•6. tumor: equal or less than 7 cm diameter
•7. signed informed consent of the study participant and compliance during the whole study duration
•8. no simultaneous participation in another clinical study (until evaluation of the primary endpoint)
•9. Leukozyten = 3000 x 103 / ml, Thrombozyten = 100000 x 10 3 / ml, Hämoglobin = 10 g/dL
•10. effective contraception for man and women during and further 12 month after the end of the treatment period.
•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

•1. ECOG > 2
•2. follicular lymphoma grade 3 (also grade 3a)
•3. Bulky disease: lymphoma > 7 cm diameter
•4. Infestation of the spleen
•5. Pretreatment: radiotherapy, chemotherapy or immunotheray
•6. second neoplasia (excluded: basalioma, spinalioma)
•7. Concomitant diseases: congenital or aquired immunodeficiency syndrome, collagen disease
•8. severe psychiatric diseases
•9. Pregnancy / Nursing
•10. Known protein allergy
•11. History of hypersensitivity to the investigational product or to any excipient present in the pharmaceutical form of the investigational product
•12. Mental condition rendering the subject incapable to understand the rational, scope and possible consequences of the trial

发起方

niversity Hospital of Heidelberg