Study of MK-1045 plus drug combination in patients with first‑line follicular lymphoma

Baseline examinations

After joining the study, initial medical examinations are performed to confirm eligibility and to record the current health status.

Tests include physical Examination, blood tests, imaging studies, and documentation of the follicular lymphoma diagnosis.

First treatment infusion

On the first treatment day, an intravenous infusion is given.

If assigned to the investigational arm, the patient receives MK-1045 (investigational drug) together with rituximab. both are administered as solutions for infusion; the exact concentration is defined by the study protocol.

If assigned to the comparator arm, the patient receives the physician’s choice chemotherapy (for example, cyclophosphamide 750 mg/m², doxorubicin 50 mg/m², bendamustine 90 mg/m², or vinorelbine 1.4 mg/m²) together with rituximab. chemotherapy drugs are given by intravenous infusion, while rituximab is also given intravenously.

In addition, oral prednisone 40 mg/m² may be prescribed according to the chemotherapy regimen.

Repeated treatment cycles

Treatment is repeated in cycles, typically every three weeks, until the planned number of cycles is completed or until the study protocol allows early discontinuation.

Each cycle includes the same intravenous infusions as described for the first day:

• Investigational arm: MK-1045 infusion plus rituximab infusion.
• Comparator arm: selected chemotherapy drug(s) plus rituximab infusion.

Oral prednisone is taken daily during the chemotherapy cycles according to the dosing schedule defined by the investigator.

Monitoring and safety assessments

Before each infusion, blood samples are taken to evaluate blood counts, liver function, kidney function and other safety parameters.

The patient is observed during and after the infusion for any immediate reactions such as fever, chills, or allergic symptoms.

Any adverse event (side effect) is recorded and evaluated for severity; if a serious adverse event occurs, treatment may be paused or discontinued.

Dose‑limiting toxicity, defined as a side effect that prevents further dosing at the planned level, is specifically monitored.

End‑of‑treatment Assessment and follow‑up

After the last scheduled cycle, imaging studies and clinical evaluations are performed to assess tumor response according to the Lugano Criteria (complete response, partial response, etc.).

The patient continues with regular follow‑up visits for up to several years to monitor disease progression, overall survival and long‑term safety.

During follow‑up, additional blood tests and imaging may be performed at intervals defined by the study protocol.