Ocena skuteczności i bezpieczeństwa połączenia venetoclax i rituximab u dorosłych z nawracającą przewlekłą białaczką limfocytową w praktyce klinicznej w Polsce

Baseline Assessment

After joining the study, undergo a clinical Examination, blood tests and a bone‑marrow sample that will be examined by flow cytometry to determine the level of disease cells (mrD).

The results are used to establish the starting point for treatment.

First <b>rituximab</b> infusion

Receive an intravenous rituximab infusion at a dose of 500 mg per square meter of body surface.

The infusion is administered in a hospital setting according to the study schedule, usually once a week for several weeks.

Initiation of <b>venetoclax</b> therapy

Begin oral treatment with venetoclax tablets.

The total daily dose is 400 mg, which is achieved by taking the appropriate combination of 10 mg, 50 mg and 100 mg film‑coated tablets.

The tablets are taken once daily, preferably at the same time each day.

Regular monitoring visits

Attend scheduled visits to the clinic every two to four weeks.

During each visit, blood is drawn to check blood counts, kidney and liver function and to assess possible side effects.

The treating physician may adjust the dose or manage any adverse reactions.

MrD testing during treatment

Provide additional bone‑marrow or blood samples at the time points defined in the protocol.

The samples are analyzed by flow cytometry to determine whether the disease level has fallen below the threshold of 10‑4 (uMRD).

Quality‑of‑life Questionnaire

Complete the EORTC QLQ‑C30 questionnaire before starting therapy and at later visits as required.

The Questionnaire evaluates physical, emotional and social aspects of health.

Hospitalisation for venetoclax titration (if required)

Spend a short period in hospital if the protocol specifies a gradual increase of the venetoclax dose before reaching the full 400 mg daily dose.

The length of stay is determined by the medical team.

Completion of treatment

Continue the combined regimen of rituximab infusions and daily venetoclax tablets for up to 24 months, unless treatment is stopped earlier because of disease response or safety reasons.

The final visit includes a comprehensive Assessment of disease status, laboratory results and quality‑of‑life scores.

Final follow‑up

After the end of therapy, attend a follow‑up visit to document the long‑term outcome and any late side effects.

The data are used to evaluate the overall effectiveness and safety of the regimen.