Early Stage Follicular LymphOma and RadioTherapy PLUS anti-CD20 Antibody
- Conditions
- Early Stage Follicular LymphOmaTherapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Registration Number
- CTIS2023-509278-41-00
- Lead Sponsor
- niversitaetsklinikum Heidelberg AöR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 130
Centrally reviewed CD20-positive follicular lymphoma grade 1/2 or 3a based on WHO classification (2016), Adequate contraception for men and women of childbearing age during therapy and 18 months thereafter, Untreated (radiation-, chemo- or immunotherapy) nodal follicular lymphoma (including involvement of Waldeyer´s ring), Age: =18 years, ECOG: 0-2, Stage: clinical stage I or II (Ann Arbor classification) based on FDG-PET Staging, 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 bone marrow capacity: ANC = 1.5 x 103/ml, thrombocytes = 100000 x 10 3/ml, hemoglobin = 10 g/dL, Capability to understand the intention and the consequences of the clinical trial
Extra nodal manifestation of follicular lymphoma, AST or ALT > 2.5 × ULN, Total bilirubin = 1.5 × ULN, INR > 1.5 × ULN, PTT or aPTT > 1.5 × the ULN, Secondary cancer in the patient's medical history (exclusion: basalioma, spinalioma, melanoma in situ, bladder cancer T1a, non-metastasized solid tumor in constant remission, which was diagnosed >3 years ago), Serious disease interfering with a regular therapy according to the study protocol, e.g: congenital or acquired immune-deficiency syndromes, active infections including viral hepatitis, uncontrolled concomitant diseases including significant cardiovascular or pulmonary disease, Severe psychiatric disease, Pregnancy / lactation, Known hypersensitivity against Obinutuzumab or Rituximab drugs with similar chemical structure or any other additive of the pharmaceutical formula of the study drug, Active hepatitis B infection (inactive hepatitis B infections require additional prophylactic anti-viral medication for 1 year (e.g. Lamivudin, Entecavir, Tenofovir), 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method