Combining low-dose radiotherapy with anti-CD20 antibody for early stage follicular lymphoma
Early Stage Follicular LymphOma and RadioTherapy PLUS Anti-CD20 Antibody
This study is testing whether a lower dose of radiation combined with a specific antibody can help people with early stage follicular lymphoma just as well as the standard treatment with a higher radiation dose.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Heidelberg University Academic / other |
| Drugs / interventions | Obinutuzumab, Rituximab, immunotherapy, radiation |
| Locations | 12 sites (Berlin and 11 other locations) |
| Trial ID | NCT05045664 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of low-dose radiotherapy (4 Gy) combined with the anti-CD20 antibody Obinutuzumab in patients with early stage follicular lymphoma. The study aims to demonstrate that this combination is non-inferior to the standard treatment of Rituximab with a higher radiation dose (24 Gy). By potentially reducing the radiation dose significantly, the trial seeks to improve patient outcomes while minimizing side effects. Participants will be closely monitored for response rates and progression-free survival.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with untreated, CD20-positive follicular lymphoma grade 1/2 or 3a, and a tumor size of 7 cm or less.
Not a fit: Patients with extra nodal manifestations of follicular lymphoma or a history of secondary cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and less harmful treatment option for patients with early stage follicular lymphoma.
How similar studies have performed: Previous studies have shown promising results with similar combinations of low-dose radiotherapy and anti-CD20 antibodies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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: clinical stage I or II (Ann Arbor classification) based on FDG-PET Staging * 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 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 clinical trial * Adequate contraception for men and women of child-bearing age during therapy and 18 months thereafter 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 constant remission, 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 including viral hepatitis, uncontrolled concomitant diseases including significant cardiovascular or pulmonary disease * Severe psychiatric disease * Pregnancy / lactation * Known hypersensitivity against Obinutuzumab or Rituximab drugs with similar chemical structure or any other additive of the pharmaceutical formula of the study drug * Active hepatitis B infection (inactive hepatitis B infections require additional prophylactic anti-viral medication for 1 year (e.g. Lamivudin, Entecavir, Tenofovir) * 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
Where this trial is running
Berlin and 11 other locations
- Vivantes Klinikum Berlin — Berlin, Germany (Recruiting)
- University of Essen — Essen, Germany (Recruiting)
- University of Göttingen — Göttingen, Germany (Recruiting)
- University Hospital Heidelberg — Heidelberg, Germany (Recruiting)
- Strahlentherapie KH Maria Hilf — Mönchengladbach, Germany (Recruiting)
- LMU München — Munich, Germany (Recruiting)
- Technische Universität München — Munich, Germany (Recruiting)
- Krankenhaus Barmherzige Brüder — Regensburg, Germany (Recruiting)
- University of Rostock — Rostock, Germany (Recruiting)
- Katharinen Hospital Stuttgart — Stuttgart, Germany (Recruiting)
- University of Tübingen — Tübingen, Germany (Recruiting)
- University of Ulm — Ulm, Germany (Recruiting)
Study contacts
- Principal investigator: Klaus Herfarth, MD — Heidelberg University
- Study coordinator: Klaus Herfarth, MD
- Email: klaus.herfarth@med.uni-heidelberg.de
- Phone: +496221568202
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.