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:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT03939234
Eligibility Criteria:
Inclusion Criteria:
* CLL according to national guidelines (Lymphoma.dk).
* Unmutated IGHV gene according to ERIC recommendations.(25)
* No prior CLL directed treatment
* Age ≥ 18
* Eastern cooperative oncology group (ECOG) performance status of 0 or 1
* No life-threatening conditions
* Adequate bone marrow function: Neutrophils \> 1,0 x 109/l; Platelets \> 100 x 109/l
* Adequate renal function: Glomeruli filtration rate (eGFR)/1,73 m2 \> 50 mL/min
* Adequate liver function: Aspartate Aminotransferase \< 100 U/L
* For fertile women: agreement to use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for at least 120 days after the last treatment.
* For men: agreement to use contraceptive measures and agreement to refrain from donating sperm.
Exclusion Criteria:
* Other active malignant diseases requiring treatment.
* Significant medical condition per investigators judgement e.g. severe Asthma or chronic obstructive lung disease (COLD), poorly regulated heart condition, insulin dependent diabetes mellitus.
* Acute or chronic viral/bacterial infection e.g. human immunodeficiency virus (HIV), Cytomegalo virus (CMV), Epstein-barr virus (EBV), hepatitis or tuberculosis
* Serious known allergies or earlier anaphylactic reactions.
* Known sensibility towards Montanide ISA51
* 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.
* Pregnant and breastfeeding women.
* Fertile women not using secure contraception with a failure rate less than \< 1%
* Psychiatric disorders that according to the investigator could influence compliance.
* Treatment with other experimental drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03939234
Study Brief:
Protocol Section:
NCT03939234