Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT03381768
Eligibility Criteria:
Inclusion Criteria:
* Histologically documented FL grade I-IIIa, with no sign of current transformation. Patients cured of transformed lymphoma are eligible.
* A minimum of one line of induction therapy. Maintenance rituximab can continue along with the vaccination
* At least partial response to the latest standard treatment
* A minimum of 4 weeks since last treatment
* Age ≥ 18
* ECOG performance status of 0 or 1
* Life expectancy ≥ 12 weeks
* Adequate hematologic and end-organ function
Exclusion Criteria:
* Progression with the presence of at least one GELF criteria or transformation at inklusion time.
* Other active malignant diseases
* Significant medical condition per investigators judgement e.g. severe Asthma/COLD, poorly regulated heart condition, insulin dependent diabetes mellitus.
* Acute or chronic viral/bacterial infection e.g. HIV, CMV, EBV, hepatitis or tuberculosis
* Serious known allergies or earlier anaphylactic reactions.
* Known sensibility towards Montanide ISA-51
* Any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc.
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03381768
Study Brief:
Protocol Section:
NCT03381768