Optymalizacja i personalizacja immunoterapii u dorosłych pacjentów z nawróconą przewlekłą białaczką limfocytową przy użyciu venetoclax, obinutuzumab i daratumumab

Enrollment i baseline Assessment

After signing the consent form, you will be assigned a study identification number.

Baseline examinations will be performed, including blood tests and imaging, to document the status of chronic lymphocytic leukaemia.

First obinutuzumab infusion

On day 1 of cycle 1, obinutuzumab will be given by injection into a vein (intravenous infusion).

The specific dose and infusion speed are defined by the study protocol and will be administered by qualified staff.

First daratumumab infusion

On day 2 of cycle 1, daratumumab will be given by injection into a vein (intravenous infusion).

The amount and frequency are determined by the protocol and may be adjusted during the study.

Start of oral venetoclax tablets

Starting on day 3 of cycle 1, you will begin taking venetoclax tablets by mouth.

The tablets are available in 10 mg, 50 mg and 100 mg film‑coated forms; the exact dose and schedule are prescribed by the study team.

The tablets are taken once daily unless the protocol specifies a different frequency.

Subsequent treatment cycles

Every cycle (typically every 28 days), additional infusions of obinutuzumab and daratumumab will be administered according to the protocol.

Oral venetoclax tablets will be continued daily throughout the treatment period.

The total number of cycles and the overall duration of therapy are defined by the study design.

Monitoring and assessments during treatment

Regular clinic visits will be scheduled to evaluate safety, side effects and response to therapy.

Blood samples will be taken to measure drug levels and to assess disease markers such as CD38 expression.

Questionnaires about quality of life may be completed at specified time points.

End of treatment and final evaluation

After the last planned cycle, treatment will be stopped and a final Assessment will be performed.

The final evaluation includes laboratory tests, imaging and determination of minimal residual disease (MR‑D) status.