Status:
UNKNOWN
Ibrutinib Adapted to Response in Patients With CLL
Lead Sponsor:
Grupo Argentino de Tratamiento de la Leucemia Aguda
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Brief Summary
As everyone knows in clinical practice, Ibrutinib dose reduction in patients with CLL with good response does not alter disease-free survival (DFS) or increase the risk of transformation. Supported b...
Detailed Description
Chronic lymphatic leukemia is the most common form of leukemia in adults, most often arising from a malignant clone of B cells with a characteristic phenotype. It is far from uniform in presentation a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05360758
Start Date
June 1 2023
End Date
December 1 2025
Last Update
December 28 2022
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