Gazyvaro and Low Dose Radiotherapy in Early Stage Follicular Lymphoma (NCT03341520) | Clinical Trial Compass
CompletedPhase 2
Gazyvaro and Low Dose Radiotherapy in Early Stage Follicular Lymphoma
Germany89 participantsStarted 2018-04-24
Plain-language summary
Combined modality approach using Obitunuzumab and involved site low dose irradiation in early stage nodal follicular lymphoma. Radiation dose will be adapted for low-responders.
Primary Objective:
Evaluation of the rate of metabolic CR after low-dose involved site radiotherapy in combination with Gazyvaro (Obinutuzumab) in early stage nodal follicular lymphoma in order to avoid conventional full dose IF radiotherapy.
Secondary Objective:
Efficacy and safety of a response adapted radiation dose treatment schedule.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Centrally reviewed CD20-positive follicular lymphoma grade 1/2 based on WHO classification (2016)
* 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 require prophylactic anti-viral therapy (e.g. Entecavir®) possible (see also 5.6. Prior and Concomitant Disease)
Exclusion Criteria:
* Extra nodal manifestation
* 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
* Concomitant diseases: congenital or acquired immune-deficiency syndromes, active infections including viral hepatitis (serology positive for HBsAg or HBcAb in combination po…