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Could a fraction of the usual radiation be enough? new trial aims to reduce treatment burden for lymphoma patients.

NCT ID NCT05045664

Disease control Sponsor: Heidelberg University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a much lower dose of radiation (4 Gy) combined with an antibody drug (obinutuzumab or rituximab) works as well as the standard high-dose radiation (24 Gy) plus rituximab for early-stage follicular lymphoma. About 100 adults with untreated stage I or II disease will take part. If successful, this approach could reduce radiation side effects while maintaining disease control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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 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

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Conditions

The condition(s) this trial relates to.

follicular lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Early stage follicular lymphoma who grade 1/2 or 3A

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Katharinen Hospital Stuttgart

    RECRUITING

    Stuttgart, Germany

  • Krankenhaus Barmherzige Brüder

    RECRUITING

    Regensburg, 93049, Germany

  • LMU München

    RECRUITING

    Munich, 81377, Germany

  • Strahlentherapie KH Maria Hilf

    RECRUITING

    Mönchengladbach, 41063, Germany

  • Technische Universität München

    RECRUITING

    Munich, 81675, Germany

  • University Hospital Heidelberg

    RECRUITING

    Heidelberg, 69120, Germany

  • University of Essen

    RECRUITING

    Essen, 45147, Germany

  • University of Göttingen

    RECRUITING

    Göttingen, 37075, Germany

  • University of Rostock

    RECRUITING

    Rostock, 18057, Germany

  • University of Tübingen

    RECRUITING

    Tübingen, 72076, Germany

  • University of Ulm

    RECRUITING

    Ulm, 89081, Germany

  • Vivantes Klinikum Berlin

    RECRUITING

    Berlin, 10967, Germany