New combo therapy aims to shrink lymphoma with less radiation
NCT ID NCT03341520
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new approach for people with early-stage follicular lymphoma, a slow-growing blood cancer. Instead of standard full-dose radiation, participants received low-dose radiation combined with the drug Obinutuzumab (Gazyvaro). The goal was to see if this combination could achieve complete remission while reducing side effects. The study enrolled 89 adults with untreated stage I or II disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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89 people
The number who actually took part.
- Started
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Apr 2018
- Finished
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Mar 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Klinikum Kempten
Kempten, Germany
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LMU
Munich, 81377, Germany
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Site Marburg
Marburg, Germany
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TU
Munich, 81675, Germany
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University of Cologne
Cologne, 50924, Germany
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University of Essen
Essen, 45122, Germany
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University of Frankfurt
Frankfurt, 60590, Germany
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University of Heidelberg
Heidelberg, 69120, Germany
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University of Muenster
Münster, Germany
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University of Tuebingen
Tübingen, Baden-Wurttemberg, Germany
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University of Ulm
Ulm, 89081, Germany
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Vivantes Klinikum
Berlin, Germany