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Ibrutinib Adapted to Response in Patients With CLL

NCT05360758 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2022-12-28

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Evaluation of response to treatment with response-tailored Ibrutinib in patients with chronic lymphocytic leukemia

Evaluation of response to treatment with response-tailored Ibrutinib in patients with chronic lymphocytic leukemia using laboratory tests, abdominal ultrasound, general condition of the patient and bone marrow

Sponsors & Collaborators

  • Grupo Argentino de Tratamiento de la Leucemia Aguda

    lead OTHER

Principal Investigators

  • Martin Bertini, Dr. · Grupo Argentino de Tratamiento de la Leucemia Aguda

  • Raimundo F Bezares, Dr. · Grupo Argentino de Tratamiento de la Leucemia Aguda

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2025-06-01
Completion
2025-12-01

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05360758 on ClinicalTrials.gov