Combining low-dose radiotherapy with anti-CD20 antibody for early stage follicular lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Klaus Herfarth, MD — Heidelberg University
• Study coordinator: Klaus Herfarth, MD
• Email: klaus.herfarth@med.uni-heidelberg.de
• Phone: +496221568202

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tafasitamab and Rituximab for newly diagnosed follicular lymphoma

  This study tests a combination of tafasitamab and rituximab to treat adults with newly diagnosed follicular lymphoma.

  Recruiting Phase 2 University of Washington · Seattle, Washington · NCT07731789

• Pirtobrutinib plus Mosunetuzumab for relapsed or refractory grade 1–3a follicular lymphoma

  This trial tests whether giving pirtobrutinib together with mosunetuzumab can better treat adults with relapsed or refractory grade 1–3a follicular lymphoma.

  Recruiting Phase 2 University of Washington · Seattle, Washington · NCT06948786

• Combining three medications for untreated follicular lymphoma

  This study is testing a new combination of three medications to see if they can effectively treat people with untreated follicular lymphoma without using traditional chemotherapy.

  Recruiting Phase 2 Chinese PLA General Hospital · Beijing · NCT06471738

• Low dose mosunetuzumab treatment for indolent B-cell lymphoma

  This study is testing a new low-dose treatment called mosunetuzumab to see if it can help people with indolent B-cell lymphoma by slowing down or stopping the growth of their cancer.

  Recruiting Phase 2 University of Washington · Seattle, Washington · NCT06442475

• Combining acalabrutinib and obinutuzumab to treat untreated follicular lymphoma and indolent non-Hodgkin lymphomas

  This study is testing if combining two treatments, acalabrutinib and obinutuzumab, can help people with untreated follicular lymphoma and other slow-growing non-Hodgkin lymphomas feel better and improve their quality of life.

  Recruiting Phase 2 Emory University · Atlanta, Georgia · NCT04883437

• Acalabrutinib, Lenalidomide, and Rituximab for Advanced Follicular Lymphoma

  This phase 2 trial tests whether the combination of acalabrutinib, lenalidomide, and rituximab can control CD20-positive stage III–IV follicular lymphoma in patients who have not yet had systemic lymphoma treatment.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT04404088

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.