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MK-0482 for Acute Myeloid & Chronic Myelomonocytic Leukemias

Q: What key objectives are investigators hoping to achieve with this research?

<p>Merck Sharp &#x26; Dohme Corp., the primary sponsor of this trial, defines its main objective as determining the Number of Participants Who Experience a Dose-Limiting Toxicity (DLT). Additionally, secondary outcomes will be assessed such as Objective Response Rate (ORR), Complete Remission (CR) Rate and Trough Plasma Concentration (Ctrough). Ctrough is calculated by measuring blood samples pre-dose and post-dose at designated points in time. ORR encompasses complete response - bone marrow blasts &#x3C;5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neut</p>

Q: How many human participants are participating in this experiment?

<p>Affirmative. The public information hosted on clinicaltrials.gov shows that the trial, which was initially posted on September 26th 2021, is currently looking for participants. 35 individuals need to be sourced from 2 separate medical facilities.</p>

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

Study Summary

This trial is testing a new drug, MK-0482, to see if it is safe and effective for patients with relapsed or refractory acute myeloid leukemia or chronic myelomonocytic leukemia.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Complete Remission (CR) Rate

Composite CR Rate

Maximum Concentration (Cmax)

+2 more

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

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Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,581,816 Total Patients Enrolled

Merck Sharp & Dohme LLCLead Sponsor

3,886 Previous Clinical Trials

5,054,541 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,474 Total Patients Enrolled

Media Library

MK-0482 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05038800 — Phase 1

Acute Myeloid Leukemia Research Study Groups: MK-0482

Acute Myeloid Leukemia Clinical Trial 2023: MK-0482 Highlights & Side Effects. Trial Name: NCT05038800 — Phase 1

MK-0482 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05038800 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has MK-0482 received endorsement from the Food and Drug Administration?

"The safety of MK-0482 is tentatively assessed with a score of 1 since this is an early Phase 1 study, meaning that the available evidence for its efficacy and security are comparatively meager."

Answered by AI

Is enrollment in the trial open at this time?

"According to information on clinicaltrials.gov, patient recruitment is currently underway for this trial which was first announced back in September 2021 and then revised as recently July 2022."

Answered by AI

What key objectives are investigators hoping to achieve with this research?

"Merck Sharp & Dohme Corp., the primary sponsor of this trial, defines its main objective as determining the Number of Participants Who Experience a Dose-Limiting Toxicity (DLT). Additionally, secondary outcomes will be assessed such as Objective Response Rate (ORR), Complete Remission (CR) Rate and Trough Plasma Concentration (Ctrough). Ctrough is calculated by measuring blood samples pre-dose and post-dose at designated points in time. ORR encompasses complete response - bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neut"

Answered by AI

How many human participants are participating in this experiment?

"Affirmative. The public information hosted on clinicaltrials.gov shows that the trial, which was initially posted on September 26th 2021, is currently looking for participants. 35 individuals need to be sourced from 2 separate medical facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate MK-0482 for Relapsed/Refractory Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia (CMML) (MK-0482-002)

2021. "A Study to Evaluate MK-0482 for Relapsed/Refractory Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia (CMML) (MK-0482-002)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05038800.