Status:
UNKNOWN
Gazyvaro and Low Dose Radiotherapy in Early Stage Follicular Lymphoma
Lead Sponsor:
Heidelberg University
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Stage II Grade 1 Follicular Lymphoma
Stage II Grade 2 Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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: E...
Detailed Description
Extended field or total nodal irradiation had been the gold standard for early stage follicular lymphoma for a long time in Germany. An involved field (IF) irradiation has been favored due to the toxi...
Eligibility Criteria
Inclusion
- 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
- 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 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
Key Trial Info
Start Date :
April 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT03341520
Start Date
April 24 2018
End Date
May 1 2024
Last Update
November 30 2023
Active Locations (12)
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1
University of Tuebingen
Tübingen, Baden-Wurttemberg, Germany
2
Vivantes Klinikum
Berlin, Germany
3
University of Cologne
Cologne, Germany, 50924
4
University of Essen
Essen, Germany, 45122