Clinical trial · Observational
Ibrutinib Adapted to Response in Patients With CLL
Ibrutinib Adapted to Response in Patients Diagnosed With Chronic Lymphatic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Evaluation of response to treatment with response-tailored Ibrutinib in patients with chronic lymphocytic leukemia | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients diagnosed with CLL with treatment criteria, first line or relapsed/refractory.
- interventionNames
- Other: Evaluation of response to treatment with response-tailored Ibrutinib in patients with chronic lymphocytic leukemia
Primary outcomes (3)
- measure
- Evaluate Progression Free Survival (PFS) in patients diagnosed with Chronic Lymphocytic Leukemia who undergo the treatment scheme protocolized by GATLA.
- timeFrame
- 24 months
- measure
- Determine global response rate with dose reduction.
- timeFrame
- 24 months
- measure
- Determine duration of response with dose reduction.
- timeFrame
- 24 months
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available