Phase
Condition
Follicular Lymphoma
Lymphoma
Treatment
Experimental
Standard
Standard
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
• Centrally reviewed CD20-positive follicular lymphoma grade 1/2 or 3a based on WHOclassification (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-PETStaging
Risk profile: Largest diameter of the lymphoma ≤ 7 cm (sectional images)
Written informed consent and willingness to cooperate during the course of thetrial
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 clinicaltrial
Adequate contraception for men and women of child-bearing age during therapyand 18 months thereafter
Exclusion
Exclusion Criteria:
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 constantremission, 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 includingviral hepatitis, uncontrolled concomitant diseases including significantcardiovascular or pulmonary disease
Severe psychiatric disease
Pregnancy / lactation
Known hypersensitivity against Obinutuzumab or Rituximab drugs with similar chemicalstructure or any other additive of the pharmaceutical formula of the study drug
Active hepatitis B infection (inactive hepatitis B infections require additionalprophylactic anti-viral medication for 1 year (e.g. Lamivudin, Entecavir, Tenofovir)
Participation in another interventional trial or follow-up period of a competingtrial which can influence the results of this current trial
Creatinine > 1.5 times the upper limit of normal (ULN) (unless creatinine clearancenormal), 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
Study Design
Connect with a study center
Vivantes Klinikum Berlin
Berlin, 10967
GermanyActive - Recruiting
University of Essen
Essen, 45147
GermanyActive - Recruiting
University of Göttingen
Göttingen, 37075
GermanyActive - Recruiting
University Hospital Heidelberg
Heidelberg, 69120
GermanyActive - Recruiting
LMU München
Munich, 81377
GermanyActive - Recruiting
Technische Universität München
Munich, 81675
GermanyActive - Recruiting
Strahlentherapie KH Maria Hilf
Mönchengladbach, 41063
GermanyActive - Recruiting
Krankenhaus Barmherzige Brüder
Regensburg, 93049
GermanyActive - Recruiting
University of Rostock
Rostock, 18057
GermanyActive - Recruiting
Katharinen Hospital Stuttgart
Stuttgart,
GermanyActive - Recruiting
University of Tübingen
Tübingen, 72076
GermanyActive - Recruiting
University of Ulm
Ulm, 89081
GermanyActive - Recruiting
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