Therapy of Nodal Follicular Non-Hodgkin Lymphoma (WHO grade 1/2) in Clinical Stage I/II using Response Adapted Involved Site Radiotherapy in Combination with Gazyvaro - GAZyvaro and response Adapted Involved-site Radiotherapy

Ruprecht-Karls-University Heidelberg, Medical Faculty represented by University Hospital Heidelberg0 个研究点目标入组 93 人开始时间: 2017年6月12日最近更新: 2024年5月13日

试验速览

暂无简介。

•Centrally reviewed CD20-positive follicular lymphoma grade 1/2 based on WHO classification (2008)
•Untreated (radiation-, chemo- or immunotherapy) nodal lymphoma (including involvement of Waldeyer´s ring)
•Age: =18 years
•ECOG: 0-2
•Stage: clinical stage I or II (Ann Arbor classification)
•Risk profile: Largest diameter of the lymphoma * 7 cm (sectional images)
•Written informed consent and willingness to cooperate during the course of the trial
•Adequate hematologic function (unless abnormalities are related to NHL), defined as follows: Hemoglobin = 9.0 g/dL; absolute neutrophil count = 1.5 × 109/L, Platelet count = 75 × 109/L
•Capability to understand the intention and the consequences of the clinical trial
•Adequate contraception for men and women of child-bearing age during therapy and 18 months thereafter
•Patients with non-active hepatitis B infection (HBsAg neg/HBcAB pos/HBV DNA neg) under 1-year prophylactic anti-viral therapy (e.g. Entecavir® or Tenofovir®) possible (see also 5.6. Prior and Concomitant Disease)
•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 19
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 74

•Extra nodal manifestation
•Secondary cancer in the patients medical history (exclusion: basalioma, spinalioma, melanoma in situ, bladder cancer T1a, non-metastasized solid tumor in constant remission, which was diagnosed >3 years ago
•Concomitant diseases: congenital or acquired immune-deficiency syndromes, active infections including viral hepatitis (serology positive for HBsAg or HBcAb in combination positive HBV DNA), uncontrolled concomitant diseases including significant cardiovascular or pulmonary disease (see also 5.6. Prior and Concomitant Disease)
•Severe psychiatric disease
•Pregnancy / lactation
•Known hypersensitivity against Gazyvaro (Obinutuzumab) or drugs with similar chemical structure or any other additive of the pharmaceutical formula of the study drug
•Participation in another interventional trial or follow-up period of a competing trial which can influence the results of this current trial
•Creatinine > 1.5 times the upper limit of normal (ULN) (unless creatinine clearance normal), or calculated creatinine clearance < 40 mL/min
•AST or ALT > 2.5 × ULN
•Total bilirubin = 1.5 × ULN
•INR > 1.5 × ULN
•PTT or aPTT > 1.5 × the ULN

发起方

Ruprecht-Karls-University Heidelberg, Medical Faculty represented by University Hospital Heidelberg