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New treatment option for Early Stage Follicular Lymphoma WHO Grade 1/2 or 3a
Official title Early Stage Follicular LymphOma and RadioTherapy PLUS Anti-CD20 Antibody
ClinicalTrials.gov ID: NCT05045664
What this study is testing
What is Standard?
Standard is an investigational medicine, being studied as a potential treatment for early stage follicular lymphoma who grade 1/2 or 3a.
Also referred to as Rituximab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Serious disease interfering with a regular therapy according to the study protocol, e.g: congenital or acquired immune-deficiency syndromes, active...
- 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...
See the full eligibility 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
- 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...
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, Germany
- Essen, Germany
- Göttingen, Germany
- Heidelberg, Germany
- Mönchengladbach, Germany
- Munich, Germany
- Regensburg, Germany
- Rostock, Germany
- Stuttgart, Germany
- Tübingen, Germany
- Ulm, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, Germany; Essen, Germany; Göttingen, Germany; Heidelberg, Germany; Mönchengladbach, Germany; Munich, Germany and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.