Not recruiting

Phase 1b Study of MK-0482 in Adults with Relapsed or Refractory Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on people whose blood cancers have returned or did not improve with earlier treatment, specifically Acute Myeloid Leukemia and Chronic Myelomonocytic Leukemia. Some participants may also have disease in the brain and spinal fluid, known as Active CNS leukemia. The medication being tested is called MK-0482 and is given as a solution that is slowly delivered into a vein (intravenous infusion). “Relapsed” means the cancer has come back, and “refractory” means it has not responded to prior therapies.

The purpose of the trial is to find out whether the medicine is safe, can be tolerated, and what dose might be used in later studies. Participants will receive the drug in a hospital setting and will have regular check‑ups to watch for side effects and to see how the drug moves through the body. The study runs for several weeks, with scheduled visits for health monitoring and blood sampling, and it ends when the planned treatment period is finished or if a participant must stop because of side effects.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and consent
You are asked to sign a consent form that explains the purpose of the study and what will be required of you.
The study staff confirms that you meet the eligibility criteria for acute myeloid leukemia or chronic myelomonocytic leukemia that has returned after previous treatment.
Step 2
Baseline assessments
A complete medical history, physical examination, and laboratory tests are performed to document your current health status.
Specific tests to evaluate the extent of leukemia, such as bone‑marrow sampling, are done before any study medication is given.
Step 3
First dose of <b>mk-0482</b> <b>intravenous infusion</b>
You receive a single infusion of mk-0482 at a dose of 750 mg administered through a vein.
The infusion is given as a solution for infusion over several hours, following the schedule defined by the study protocol.
Step 4
Immediate post‑infusion monitoring
Vital signs such as blood pressure, pulse, and temperature are checked regularly for a few hours after the infusion.
Staff watch for any immediate reactions, including signs of a dose‑limiting toxicity (a severe side effect that may stop further dosing).
Step 5
Regular safety assessments
At each study visit you undergo blood tests and symptom checks to identify any adverse events (unwanted medical occurrences).
These assessments continue throughout the treatment period to ensure the medication is tolerated.
Step 6
Pharmacokinetic and pharmacodynamic sampling
Blood samples are taken at specified times to measure the concentration of mk-0482 in your bloodstream (pharmacokinetics) and its effect on leukemia cells (pharmacodynamics).
The timing of these samples follows the study schedule.
Step 7
Disease response evaluation
Periodic bone‑marrow examinations and other tests are performed to determine whether the leukemia is responding to treatment.
Responses are classified using standard criteria such as complete remission or partial remission.
Step 8
Subsequent treatment cycles
If you continue in the study, additional cycles of the 750 mg mk-0482 infusion are given according to the protocol.
Each cycle is followed by the same safety, laboratory, and response assessments described above.
Step 9
Final study visit and exit
After the last planned dose or if treatment is stopped early, a final set of assessments is performed to document overall safety and any lasting effects.
The study staff summarizes the findings and provides you with information about the next steps for your care.

Who can join the trial?

5 criteria

You must have a confirmed diagnosis of Acute Myeloid Leukemia (AML) that is of the myelomonocytic or monoblastic/monocytic type, as defined by the World Health Organization (WHO) guidelines.
Your disease must be refractory (does not respond to treatment) or relapsed (has come back) after receiving standard therapies, with at least 5% leukemia cells (called blasts) found in the bone marrow or blood.
Alternatively, you may have a confirmed diagnosis of Chronic Myelomonocytic Leukemia (CMML) according to WHO criteria, and the disease must also be refractory or relapsed after standard treatments.
Both men and women are eligible to participate.
People of any age, including children and adults, may be eligible.

Who cannot join the trial?

17 criteria

Has active central nervous system (CNS) leukemia, meaning leukemia that is affecting the brain or spinal cord.
Has known HIV infection or hepatitis B or C infection, or tests that show hepatitis B surface antigen, hepatitis B DNA, hepatitis C antibody, or hepatitis C RNA are positive.
Has a mental health condition or a substance‑use problem (such as drug or alcohol abuse) that would make it difficult to follow the study requirements.
Is pregnant, breastfeeding, planning to become pregnant, or planning to father a child at any time from the screening visit through 120 days after the last dose of the study drug.
Received cancer treatment (chemotherapy, radiation therapy, or surgery) within 2 weeks before starting the study medication.
Received blood‑building medicines such as granulocyte colony‑stimulating factor (G‑CSF), granulocyte‑macrophage colony‑stimulating factor (GM‑CSF), or erythropoietin within 2 weeks before the first dose.
Received a live or weakened‑virus vaccine within 30 days before the first dose of the study medication.
Is currently taking part in another clinical trial with an experimental drug or device, or has done so within 14 days before receiving the study drug.
Has an immune‑deficiency disorder or is taking strong steroids (more than 10 mg of prednisone‑equivalent per day) or other medicines that suppress the immune system within 7 days before the first dose.
Has leukemia that is only outside the bone marrow or blood (called isolated extramedullary disease) with no involvement of the bone marrow or peripheral blood.
Has a type of leukemia called acute promyelocytic leukemia or leukemia that has the Philadelphia chromosome (Ph+ AML).
Received a donor stem‑cell transplant or an organ transplant within 60 days before starting the study medication.
Has had another cancer unless that cancer was treated with curative intent and the patient has been cancer‑free for at least 1 year.
Has had any major heart or blood‑vessel problems in the past 6 months, such as a heart attack, unstable chest pain, stroke, mini‑stroke (transient ischemic attack), heart bypass surgery, or a blood clot in the lungs, or has severe (NYHA Class III‑IV) heart failure.
Has had a severe allergic reaction to a monoclonal antibody (a lab‑made protein medicine) or any part of the study drug.
Has an active infection that is not under control and requires specific treatment.
Has life‑threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with low oxygen levels, shock, or widespread clotting in the blood (disseminated intravascular coagulation).

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Verified sites

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Hospital Universitario De Salamanca
Verified
Salamanca, Spain

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Investigated drugs

MK-0482 is an experimental medicine being tested in this study. It is given through an IV (intravenous) infusion, which means it is delivered directly into the bloodstream using a drip. The drug is being studied on its own (monotherapy) to see how safe it is, how well patients can tolerate it, and how it behaves inside the body (its pharmacokinetics and pharmacodynamics). The trial focuses on people whose acute myeloid leukemia or chronic myelomonocytic leukemia has come back or has not responded to other treatments.

Mk-0482

What is already known about the treatment

MK-0482 - This medication is given as an intravenous infusion of a sterile solution, typically 750 mg administered through a vein over a set period. It is an experimental anticancer drug currently being studied in a Phase 1b trial and has not yet received regulatory approval. The drug is being tested for use in relapsed or refractory acute myeloid leukemia, chronic myelomonocytic leukemia, and active central‑nervous‑system leukemia. It works by blocking a specific protein that cancer cells need to survive, classifying it as a small‑molecule targeted therapy for blood‑related cancers.

Investigated diseases

Central nervous system leukemia - A condition in which leukemic cells invade the brain, spinal cord, and cerebrospinal fluid. It often appears during or after systemic leukemia and can spread throughout the central nervous system. As the disease progresses, neurological symptoms such as headache, vision changes, or seizures may become more frequent.