Ibrutinib Adapted to Response in Patients With CLL

NCT05360758 | Unknown

• 1 other identifier: GATLA 11-LLC-21
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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 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

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic Leukemia; CLL; Ibrutinib

Outcome Measures

Primary Outcomes (3)

• Evaluate Progression Free Survival (PFS) in patients diagnosed with Chronic Lymphocytic Leukemia who undergo the treatment scheme protocolized by GATLA.

  24 months

• Determine global response rate with dose reduction.

  24 months

• Determine duration of response with dose reduction.

  24 months

Secondary Outcomes (2)

• Evaluate Overall Survival (OS) in patients diagnosed with Chronic Lymphocytic Leukemia who undergo the treatment scheme protocolized by GATLA.

  24 months

• Assess rate of adverse events grade 3 or more.

  24 months

Study Arms (1)

Patients diagnosed with CLL with treatment criteria, first line or relapsed/refractory.

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

Interventions

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

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

Patients diagnosed with CLL with treatment criteria, first line or relapsed/refractory.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with CLL with treatment criteria, first line or relapsed/refractory in Argentina.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grupo Argentino de Tratamiento de la Leucemia Aguda: lead

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Bertini, Dr.

  Grupo Argentino de Tratamiento de la Leucemia Aguda

  PRINCIPAL INVESTIGATOR

• Raimundo F Bezares, Dr.

  Grupo Argentino de Tratamiento de la Leucemia Aguda

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Astrid Pavlovsky, Dr.

CONTACT

5491150613683; astridp@intramed.net

Paula Freigeiro

CONTACT

5491140470052; gatla.ar@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 4, 2022
• Study Start: June 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will become available on June 2022, and will remain available until the end of the clinical trial.