What side effects are associated with this type of intervention?

Common treatments for Acute Myeloid Leukemia, such as hypomethylating agents like azacitidine and decitabine, often result in side effects including cytopenias (reduction in blood cell counts), febrile neutropenia (fever with low white blood cell count), and infections. Patients frequently experience fatigue, nausea, and vomiting. Severe side effects can include liver and kidney dysfunction, necessitating regular monitoring of liver chemistries and renal function. Hospitalization for neutropenic fever is also common, and growth factor support may be required to manage these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Acute Myeloid Leukemia (AML), including hypomethylating agents such as azacitidine and decitabine, which have shown superior survival rates compared to supportive care. IDH inhibitors are also approved for patients with specific genetic mutations (IDH1 or IDH2). Gemtuzumab ozogamicin, an antibody-drug conjugate targeting CD33, is another approved treatment option. Maintenance therapies like oral azacitidine (CC-486) are used to delay relapse in patients who have achieved remission. These treatments aim to improve overall survival and manage relapse in AML patients.

What other types of research exist?

Promising novel alternatives to MK-0482 for AML patients include: 1) BPR1K871, a multi-kinase inhibitor with efficacy in AML xenograft models. 2) NSC3852, a histone deacetylase inhibitor identified for potential use in pediatric AML. 3) Cercosporamide, a Mnk inhibitor showing antileukemic effects. 4) Idasanutlin (RG7388), an MDM2 antagonist under investigation for its efficacy and toxicity profile in AML. 5) CB-5339, a second-generation VCP inhibitor targeting DNA repair mechanisms in AML.

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MK-0482 for Acute Myeloid & Chronic Myelomonocytic Leukemias

Phase 1

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 27 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing MK-0482, a new drug for blood cancers, in patients whose cancer has come back or did not respond to previous treatments. The study aims to find out if the drug is safe, how it interacts with the body, and the best dose to use.

Who is the study for?

This trial is for adults with relapsed or refractory Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia (CMML). Participants must have previously treated AML or CMML that's active again or not responding to treatment. Exclusions include those with CNS leukemia, recent serious heart issues, uncontrolled infections, severe leukemia complications, certain psychiatric disorders, pregnancy/breastfeeding, recent other clinical trials participation, immunodeficiency on steroids/immunosuppressants within 7 days before the study drug administration.

What is being tested?

MK-0482 is being tested in this study. The first part of the trial will determine the safest dose by gradually increasing it among participants. The second part will focus on how well MK-0482 works at this determined safe dose specifically for people with relapsed/refractory AML.

What are the potential side effects?

While specific side effects of MK-0482 are not listed here, common side effects from similar treatments may include nausea and vomiting, fatigue, fever and chills due to low white blood cell counts (increasing infection risk), bleeding or bruising easily due to low platelets.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 27 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 27 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 27 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Who Discontinue Study Treatment Due to an AE

Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)

Number of Participants Who Experience at Least One Adverse Event (AE)

Secondary study objectives

Complete Remission (CR) Rate

Composite CR Rate

Maximum Concentration (Cmax)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: MK-0482Experimental Treatment1 Intervention

Participants will receive MK-0482 monotherapy administered in escalating doses as an intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Acute Myeloid Leukemia (AML) include hypomethylating agents (HMAs) such as azacitidine and decitabine, which work by inhibiting DNA methylation, leading to the reactivation of tumor suppressor genes and induction of cancer cell differentiation and apoptosis. Targeted therapies, like FLT3 inhibitors, specifically inhibit mutated proteins that drive leukemia cell proliferation. Immunotherapies aim to enhance the body's immune response against leukemia cells. These mechanisms are crucial for AML patients as they offer tailored approaches to disrupt the growth and survival of leukemia cells, potentially improving outcomes in relapsed or refractory cases.

Immunotherapy in AML: a brief review on emerging strategies.Epigenetic deregulation in myeloid malignancies.Molecular targeting in acute myeloid leukemia.