Badanie bezpieczeństwa i skuteczności MK-1045 oraz tocilizumabu u pacjentów z chłoniakiem nieziarniczym

Confirmation of enrollment

After signing the consent form, you receive confirmation that you are part of the study and are assigned to a specific study arm.

The assigned arm determines whether the medication MK-1045 will be given intravenously (IV) or by subcutaneous (sc) injection.

Baseline examinations

Initial medical examinations, blood tests, and imaging studies are performed to document the status of non‑hodgkin lymphoma before any study medication is given.

These results serve as a reference point for later safety and effectiveness assessments.

First dose administration

The first dose of MK-1045 is administered according to the route assigned to your arm:

- if you are in an IV arm (arms 1, 2, or 4), the medication is delivered through a vein using an infusion pump.

- if you are in the sc arm (arm 3), the medication is injected under the skin.

Early safety monitoring

Shortly after the first dose, you return for a visit to assess any immediate side effects, called adverse events, and to repeat selected laboratory tests.

The study staff records any adverse events and determines whether the medication is tolerated.

Subsequent dosing cycles

Additional doses of MK-1045 are given at regular intervals defined by the study protocol (for example, every two weeks).

Each dosing visit follows the same procedure as the first dose, using the same route (IV or sc) as assigned.

Between doses you may have scheduled visits for safety checks, including blood tests and physical examinations.

Efficacy assessments

Periodically, imaging studies are performed to evaluate the tumor response.

The response is measured using the Lugano response Criteria, a standardized method for classifying changes in lymphoma size.

The primary measure of effectiveness is the objective response rate (ORR), which indicates the proportion of participants whose tumors shrink or disappear.

End of treatment evaluation

When the planned number of dosing cycles is completed or if treatment is stopped early due to safety reasons, a final Assessment is performed.

This includes a full safety review, laboratory tests, and imaging to document the final tumor status.

Post‑treatment follow‑up

After treatment ends, you continue to attend follow‑up visits for several months to monitor long‑term safety and to record the duration of any tumor response.

These visits may include blood tests, physical examinations, and occasional imaging studies.