Phase 2/3 study of MK-1045 with rituximab drug combination in patients with newly diagnosed follicular lymphoma

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What is this study about?

Follicular Lymphoma is a type of blood cancer that starts in the cells that help the body fight infections. It usually grows slowly and can affect lymph nodes, the spleen, or other organs. The trial investigates a new medicine called MK-1045 used together with an existing therapy, rituximab. Both medicines are given by an intravenous infusion, which means they are slowly poured into a vein through a small tube.

The purpose of the study is to see whether the combination of MK-1045 and rituximab is safe and works better than the usual chemotherapy plus rituximab. Participants receive a series of infusions over several weeks, with regular check‑ups to monitor side effects, such as any unwanted health problems, and to assess how well the disease responds. The trial follows each person for many months to track whether the cancer stays under control and to evaluate overall health and quality of life.

1 initial study visit

after joining the study, a baseline visit is scheduled. during this visit, medical history, physical examination, laboratory tests, and imaging scans are performed to document the status of follicular lymphoma.

the information collected serves as a reference point for later comparisons of treatment effect.

2 randomization to treatment arm

based on the study design, each participant is assigned either to the mk-1045 plus rituximab arm or to the physician’s choice chemotherapy plus rituximab arm.

the assignment is made by the study team and cannot be influenced by the participant.

3 administration of mk-1045 plus rituximab

participants in the test arm receive an intravenous infusion of mk-1045 (provided as a solution for infusion) together with an intravenous infusion of rituximab (also a solution for infusion).

the exact dose of each drug is defined by the study protocol; the infusion is given under medical supervision and may be repeated in cycles according to the schedule established by the investigators.

infusion details such as rate and duration are controlled by the clinical staff to ensure safety.

4 administration of comparator chemotherapy plus rituximab

participants assigned to the comparator arm receive intravenous chemotherapy drugs together with rituximab.

the chemotherapy agents and their doses are:

cyclophosphamide: 750 mg/m2 (milligrams per square meter of body surface area) given by infusion,

doxorubicin: 50 mg/m2 given by infusion,

bendamustine: 90 mg/m2 given by infusion,

vinorelbine (listed as vincristine in the source): 1.4 mg/m2 given by infusion,

prednisolone (or prednisolone equivalent): 40 mg/m2 taken orally.

each drug is administered according to the study schedule, typically in repeated cycles.

5 regular monitoring visits

throughout the treatment period, participants attend scheduled clinic visits for safety monitoring.

laboratory tests (blood counts, chemistry panels), vital‑sign checks, and additional imaging are performed to detect adverse events and to evaluate disease response.

any side effects are recorded and reported to the study investigators.

6 assessment of treatment response

at predefined intervals, imaging studies are reviewed using the Lugano response criteria to determine whether a complete response, partial response, or disease progression has occurred.

the primary efficacy endpoint for part 1 is the complete response rate; for part 2 the endpoint is progression‑free survival.

7 completion of treatment phase

after the final scheduled cycle of either mk-1045 plus rituximab or chemotherapy plus rituximab, a final treatment assessment is performed.

this includes a full set of laboratory tests, imaging, and documentation of any adverse events that led to discontinuation of study medication.

8 long‑term follow‑up

following the end of treatment, participants enter a follow‑up period during which periodic visits are scheduled to monitor for disease recurrence and overall survival.

follow‑up assessments continue for up to 30 months, as the study evaluates the durability of complete responses and overall survival outcomes.

quality‑of‑life questionnaires may be completed at these visits to assess functional status.

Who Can Join the Study?

  • You must have a confirmed diagnosis of follicular lymphoma that has not been treated before, proven by a tissue sample called a biopsy, and the cancer cells must show the markers CD19 and CD20.
  • Your disease must be visible and measurable on imaging scans (such as CT or PET) using the Lugano response criteria, which are guidelines doctors use to evaluate lymphoma.
  • You need to provide a recent tissue sample taken by a core or excisional biopsy, or have stored tumor tissue that has never been treated with radiation.
  • If you are HIV-positive, your HIV must be well‑controlled while you are on antiretroviral therapy (ART), which are medicines that keep the virus suppressed.
  • If you test positive for hepatitis B surface antigen (HBsAg), you must have an undetectable hepatitis B virus (HBV) viral load and have been taking HBV antiviral medication for at least four weeks, continuing it during the study.
  • If you have a history of hepatitis C virus (HCV) infection, you must have an undetectable HCV viral load.
  • Both men and women are eligible to participate.

Who Cannot Join the Study?

  • Has received any previous systemic anticancer therapy (medicine that travels through the whole body to treat cancer) or radiotherapy (treatment using radiation) for follicular lymphoma.
  • Has a known active CNS lymphoma (cancer in the brain or spinal cord) or any involvement of the central nervous system.
  • Has an active autoimmune disease (a condition where the body’s immune system attacks itself) that needed medication affecting the whole body in the past two years.
  • Has an active infection that requires medication that works throughout the body.
  • Has chronic liver disease, including liver cirrhosis (severe scarring of the liver) classified as Child‑Pugh class B or C (more advanced liver damage).
  • Has not fully recovered from major surgery or still has complications from surgery.
  • Has follicular large B‑cell lymphoma or any other type of follicular lymphoma that is not the usual “classical” form.
  • Has follicular lymphoma that has transformed (changed) into a faster‑growing, more aggressive type of lymphoma.
  • Has a history or current presence of significant central nervous system (CNS) disease (serious problems affecting the brain or spinal cord).
  • Has a history of serious cardiovascular (heart) or cerebrovascular (brain‑blood‑vessel) diseases.
  • Is infected with HIV and has a past history of Kaposi’s sarcoma or Multicentric Castleman’s Disease (specific illnesses linked to weakened immunity).
  • Has received a live or live‑attenuated vaccine (a vaccine containing weakened germs) within 30 days before the first study dose.
  • Has a diagnosed immunodeficiency (weak immune system) or is taking long‑term systemic steroid medication.
  • Has another cancer that is currently getting worse or has needed active treatment within the past three years.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Salamanca Salamanca Spain

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Virgen De La Victoria Malaga Spain
Himudayx Vglm dhnlsjpl Barcelona Spain
Chwwzq Hprpltywnnz Ugwwbbvqycdbb Dq Dycmm Dijon France
Czgpyk Hyxraaoedbd Rizwyalc Uyjpkwuktlqjr Da Tfwxa Tours France
Iznujdgc Ccsoxd Dbgqkmtbcbhwbarqu L'hospitalet De Llobregat Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
08.05.2026
Spain Spain
Not yet recruiting
08.05.2026

Trial locations

MK-1045 is an experimental drug being tested for the first time in patients with follicular lymphoma. In this study it is given through an IV infusion together with rituximab. The purpose is to see if the combination is safe, tolerable, and effective at shrinking the cancer.

Rituximab is a monoclonal antibody that targets a protein called CD20 on the surface of B‑cells, which are the cells that become cancerous in follicular lymphoma. It is given by IV infusion and helps the immune system recognize and destroy the cancer cells. In this trial rituximab is used together with MK‑1045 or with standard chemotherapy regimens.

Tocilizumab is a medication that blocks the activity of a substance in the body called interleukin‑6, which can cause inflammation. It is listed as a background therapy, meaning some patients may already be taking it for other reasons, but it is not a primary part of the study treatment.

Cyclophosphamide is a chemotherapy drug that interferes with the DNA of rapidly growing cells, including cancer cells. It is given by IV infusion and is used as part of the physician’s choice chemotherapy regimen that is compared with the MK‑1045 + rituximab combination.

Doxorubicin (doxorubicin hydrochloride) is a chemotherapy agent that works by inserting itself into DNA and stopping cancer cells from dividing. It is administered by IV infusion and is also part of the standard chemotherapy regimen used for comparison in the study.

Prednisolone is an oral steroid that helps reduce inflammation and can lessen side effects of chemotherapy, such as allergic reactions and swelling. It is taken by mouth and is included in the comparator chemotherapy treatments.

Bendamustine is a chemotherapy drug that damages the DNA of cancer cells, leading to their death. It is given by IV infusion and is another option in the physician’s choice chemotherapy regimen used as a comparison to the experimental treatment.

Vinorelbine (listed under the name VINCRISTINE) is a chemotherapy medication that stops cancer cells from growing by interfering with the formation of microtubules, which are needed for cell division. It is administered through an IV infusion and is part of the standard chemotherapy options used for comparison.

Investigated diseases:

Follicular Lymphoma – Follicular lymphoma is a slow‑growing cancer of the white blood cells called B‑lymphocytes. It usually starts in the lymph nodes and can spread to the spleen, bone marrow, or blood over time. The disease often causes painless swelling of lymph nodes that may become larger as it progresses. It can remain stable for years, but in some cases it may change into a faster‑growing form. Symptoms may gradually increase as the affected organs are impacted.

Trial ID:
2025-522777-10-00
Protocol code:
MK-1045-007
Trial Phase:
Therapeutic use (Phase IV)

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