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 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 12:12 AM
NCT ID:
NCT05360758
Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with CLL with criteria for starting treatment.
* Patients diagnosed with relapsed/refractory CLL.
* Patients diagnosed with CLL not exposed to iBTK.
* Patients with a diagnosis of CLL older than 18 years.
* Patients who have been diagnosed within the six months prior to the start of the registry will also be eligible, if they are followed prospectively by the participating centers and the required information is available.
* Signature of the informed consent.
* Patients who understand the risk of pregnancy during treatment and are willing to use safe contraceptive methods.
Exclusion Criteria:
* CLL without criteria for starting treatment.
* Small cell lymphocytic lymphoma.
* Previous exposure to iBTK.
* HIV positive, hepatitis B or C positive (unless there is vaccination), Chagas positive or HTLV-1 positive.
* Performance Status (ECOG) \>= 3.
* Second active malignancy currently requiring treatment (with the exception of basal cell carcinoma).
* Class III or IV heart failure, previous acute myocardial infarction, unstable angina, ventricular tachyarrhythmias requiring treatment, severe COPD with hypoxemia, uncontrolled DBT or uncontrolled hypertension, active gastric ulcer.
* Active viral, bacterial, or fungal infection.
* Impaired renal function with clearance \< 40 mL/min.
* BT/BD, GOT/GPT x 2.
* Mental deficiency that prevents adequate understanding of the treatment requirements.
* Thrombocytopenia (\<30,000).
* Use of oral anticoagulants.
* Pregnancy / Lactation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05360758
Study Brief:
Protocol Section:
NCT05360758