Therapy of follicular lymphoma with radiotherapy an antibody
- Conditions
- nodal follicular lymphoma grade 1 or grade 2 in the clinical stage I or II (Ann Arbor classification)MedDRA version: 23.0Level: PTClassification code 10029603Term: Non-Hodgkin's lymphoma stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2021-000362-15-DE
- Lead Sponsor
- Ruprecht-Karls-University Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg and its Commercial
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 130
•Centrally reviewed CD20-positive follicular lymphoma grade 1/2 or 3a based on WHO classification (2008)
•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
•Adequate contraception for men and women of child-bearing age during therapy and 18 months thereafter
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
?Extra nodal manifestation of follicular lymphoma
?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
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