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Study of Relatlimab, Nivolumab, and 5-Azacytidine for Acute Myeloid Leukemia in Patients Not Eligible for Intensive Chemotherapy

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What is this study about?

This clinical trial is focused on studying treatments for Acute Myeloid Leukemia (AML), a type of cancer that affects the blood and bone marrow. The study involves two groups of patients: those with relapsed or refractory AML, meaning the disease has returned or not responded to previous treatments, and those who are newly diagnosed and have not received any prior treatment. The trial will explore the use of several medications, including Relatlimab, Nivolumab (also known by its code name BMS-936558), 5-Azacytidine, and Venetoclax. These medications are being tested in different combinations to see how effective they are in treating AML.

The purpose of the study is to find the best dose and understand the side effects of these drug combinations. The trial is divided into two phases. In the first phase, researchers will determine the safest and most effective dose of the medications. In the second phase, they will evaluate how well the treatment works in reducing the cancer cells in the blood and bone marrow. The study will also look at how long patients respond to the treatment and their overall survival rates.

Participants in the study will receive the medications either as a pill taken by mouth or as an infusion, which is a method of delivering the drug directly into the bloodstream through a vein. The trial will help researchers understand if these new combinations of drugs can provide better outcomes for patients with AML who are not eligible for intensive chemotherapy. The study is expected to continue until 2026, providing valuable insights into the treatment of this challenging disease.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

A negative pregnancy test is required for females of childbearing potential, and adequate contraception methods must be in place for both males and females.

2 lead-in phase I

The first phase involves determining the maximum tolerated dose and any dose-limiting side effects of the medications.

For patients with relapsed or refractory acute myeloid leukemia (AML), the treatment includes relatlimab, nivolumab, and 5-azacytidine.

For newly diagnosed patients who are not fit for intensive chemotherapy, the treatment includes relatlimab, nivolumab, 5-azacytidine, and venetoclax.

3 expansion phase II

This phase aims to estimate the overall response rate to the treatment.

Patients with relapsed or refractory AML receive relatlimab, nivolumab, and 5-azacytidine.

Newly diagnosed patients who are not fit for intensive chemotherapy receive relatlimab, nivolumab, 5-azacytidine, and venetoclax.

4 medication administration

Venetoclax is administered orally.

5-azacytidine is given as a subcutaneous injection.

Nivolumab and relatlimab are administered through intravenous infusion.

5 monitoring and follow-up

Regular monitoring is conducted to assess the response to treatment and any side effects.

The duration of response, disease-free survival, and overall survival are evaluated throughout the trial.

Who Can Join the Study?

  • Patients with Acute Myeloid Leukemia (AML) who have not responded to initial chemotherapy or have relapsed after achieving remission.
  • Patients with AML who have not responded to up to one previous salvage therapy.
  • At least 2 weeks or at least 5 half-lives must have passed since the last treatment before starting the study medication.
  • Must provide written informed consent to participate in the study.
  • If previously treated for Graft-versus-Host Disease (GvHD), it should be of grade A or less, and managed with no more than 10 mg of prednisone without additional immunosuppressive therapies.
  • Females of childbearing potential must have a negative pregnancy test and use adequate contraception. Males must also use adequate contraception.
  • Patients with previously untreated AML who do not have specific genetic mutations (NPM1 and IDH 1/2) and are not eligible for or decline standard induction therapy.
  • Patients not eligible for intensive chemotherapy or a stem cell transplant.
  • Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less, which indicates the level of daily functioning.
  • Must be 18 years of age or older.
  • Total bilirubin levels should be no more than 2 times the upper limit of normal, or 3 times if due to leukemia or Gilbert’s syndrome.
  • AST and ALT liver enzymes should be no more than 2.5 times the upper limit of normal, or 5 times if due to leukemia.
  • Serum creatinine should be no more than 2 times the upper limit of normal, or the glomerular filtration rate (GFR) should be at least 50 mL/h, indicating kidney function.
  • Must have adequate heart function, with a left ventricular ejection fraction (LVEF) of at least 50% as shown by an echocardiogram.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than Acute Myeloid Leukemia (AML) cannot participate. AML is a type of blood cancer.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who are not able to take the study medications safely cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have had another cancer treatment recently that might interfere with the study cannot participate.
  • Patients who have allergies to the study medications cannot participate.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Kpgsgwup dbc Ucpwpoyqroof Mvxvgjpx Abk Munich Germany

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

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
05.05.2021

Trial locations

Investigated drugs:

Relatlimab is an experimental medication being studied for its potential to help the immune system fight cancer. It is used in combination with other medications to treat patients with acute myeloid leukemia (AML) who have not responded to previous treatments or who are newly diagnosed and cannot undergo intensive chemotherapy.

Nivolumab is a medication that helps the immune system recognize and attack cancer cells. It is used in combination with other treatments to enhance the body’s ability to fight acute myeloid leukemia.

5-Azacytidine is a medication that works by interfering with the growth of cancer cells. It is used in combination with other drugs to treat acute myeloid leukemia, helping to slow down or stop the progression of the disease.

Venetoclax is a medication that targets specific proteins in cancer cells, leading to their death. It is used in combination with other treatments for patients with newly diagnosed acute myeloid leukemia who are not eligible for intensive chemotherapy.

Investigated diseases:

Acute Myeloid Leukemia – Acute Myeloid Leukemia (AML) is a type of cancer that affects the blood and bone marrow, characterized by the rapid growth of abnormal white blood cells. These abnormal cells accumulate in the bone marrow, interfering with the production of normal blood cells. As the disease progresses, it can lead to symptoms such as fatigue, frequent infections, and easy bruising or bleeding due to the lack of healthy blood cells. AML can occur at any age but is more common in adults. The disease is classified into different subtypes based on specific genetic and chromosomal abnormalities. The progression of AML can vary, with some cases advancing quickly while others may develop more slowly.

Trial ID:
2024-514948-89-00
Protocol code:
CA224-065
NCT ID:
NCT04913922
Trial Phase:
Human Pharmacology (Phase I) – Other

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