Early Stage Follicular LymphOma and RadioTherapy PLUS Anti-CD20 Antibody
Recruiting
Phase 3
Interventional Study
Early Stage Follicular Lymphoma WHO Grade 1/2 or 3a
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- Heidelberg University · Other
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About This Trial
The MIR study proved the effect of Rituximab in combination with a localized irradiation given in a standard dose. Together with the TROG 99.03 trial, this led to the recommendation of using this combined approach in early stage nodal follicular lymphoma. The GAZAI study is currently looking for the effect of a low dose radiotherapy of 2x2 Gy in combination with Obinutuzumab. The combination seems…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* • 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: clini…
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