Ibrutinib Adapted to Response in Patients With CLL - Trial NCT05360758
Access comprehensive clinical trial information for NCT05360758 through Pure Global AI's free database. This phase not specified trial is sponsored by Grupo Argentino de Tratamiento de la Leucemia Aguda and is currently Not yet recruiting. The study focuses on Chronic Lymphocytic Leukemia. Target enrollment is 80 participants.
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Study Focus
Evaluation of response to treatment with response-tailored Ibrutinib in patients with chronic lymphocytic leukemia
Observational
other
Sponsor & Location
Grupo Argentino de Tratamiento de la Leucemia Aguda
Timeline & Enrollment
N/A
Jun 01, 2023
Dec 01, 2025
Primary Outcome
Evaluate Progression Free Survival (PFS) in patients diagnosed with Chronic Lymphocytic Leukemia who undergo the treatment scheme protocolized by GATLA.,Determine global response rate with dose reduction.,Determine duration of response with dose reduction.
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 by the evidence of retrospective studies that have shown parity in DFS and OS
 between a group with standard treatment and another in which the dose of ibrutinib was
 reduced and others in which no significant differences were observed in the saturation point
 of the BTK receptor with good clinical response, even comparing plasma and intracellular
 pharmacokinetics and BTK occupancy together with the pharmacodynamic response, we propose to
 carry out a prospective response-adapted study with the aim of potentially reducing the rate
 of adverse events and improving the cost/benefit ratio of this therapy. Evaluating the
 efficacy and safety of Ibrutinib dose appropriate to the response in patients diagnosed with
 CLL.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05360758
Non-Device Trial