MRX-2843 for Acute Myeloid Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Emory University, Children's Healthcare of Atlanta, Atlanta, GAAcute Myeloid Leukemia+2 MoreMRX-2843 - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new drug for people with leukemia who haven't responded to other treatments. The drug will be given in increasing doses to see what effect it has.

Eligible Conditions
  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Mixed Phenotype Acute Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 10 Secondary · Reporting Duration: Day 1 and Day 23 of Cycle 1 (each cycle is 28 days)

Day 28
Determine Maximum Tolerated Dose (MTD) in mg of MRX-2843
Day 28
Percentage of subjects with Dose Limiting Toxicities (DLTs)
Month 8
Percentage of subjects with Adverse Events (AEs) and Serious Adverse Events (SAEs) graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5
Day 28
AUC0-inf: area under the concentration-time curve from time 0 to infinity
AUC0-t: area under the concentration-time curve from time 0 to the time of the last
AUC0-τ: area under the concentration-time curve from time 0 to tau, where tau is the dosing interval
CL/F: apparent total body clearance
Cmax: maximum observed plasma concentration
Tmax: time to reach maximum observed plasma concentration
Vz/F: apparent volume of distribution of the terminal phase
t1/2: apparent terminal elimination half-life
λz: terminal phase elimination rate constant

Trial Safety

Safety Progress

1 of 3

Trial Design

6 Treatment Groups

Dose Escalation - Level 4
1 of 6
Expansion Arm at RP2D
1 of 6
Dose Escalation - Level 5
1 of 6
Dose Escalation - Level 1
1 of 6
Dose Escalation - Level 3
1 of 6
Dose Escalation - Level 2
1 of 6

Experimental Treatment

50 Total Participants · 6 Treatment Groups

Primary Treatment: MRX-2843 · No Placebo Group · Phase 1

Dose Escalation - Level 4
Drug
Experimental Group · 1 Intervention: MRX-2843 · Intervention Types: Drug
Expansion Arm at RP2D
Drug
Experimental Group · 1 Intervention: MRX-2843 · Intervention Types: Drug
Dose Escalation - Level 5
Drug
Experimental Group · 1 Intervention: MRX-2843 · Intervention Types: Drug
Dose Escalation - Level 1
Drug
Experimental Group · 1 Intervention: MRX-2843 · Intervention Types: Drug
Dose Escalation - Level 3
Drug
Experimental Group · 1 Intervention: MRX-2843 · Intervention Types: Drug
Dose Escalation - Level 2
Drug
Experimental Group · 1 Intervention: MRX-2843 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 and day 23 of cycle 1 (each cycle is 28 days)

Who is running the clinical trial?

Meryx, Inc.Lead Sponsor
1 Previous Clinical Trials
45 Total Patients Enrolled
William Blum, MDPrincipal InvestigatorEmory University
2 Previous Clinical Trials
16 Total Patients Enrolled
Thomas Alexander, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center, Children's
Joshua Zeidner, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center
1 Previous Clinical Trials
53 Total Patients Enrolled
Melinda Pauley, MDPrincipal InvestigatorEmory University, Children's Healthcare of Atlanta

Eligibility Criteria

Age Any Age · All Participants · 9 Total Inclusion Criteria

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Frequently Asked Questions

Is the enrollment window for this study still open?

"This clinical trial is actively recruiting participants, as indicated by its listing on the clinicaltrials.gov site. The posting date of April 1st 2022 and most recent update from July 6th are also noted there." - Anonymous Online Contributor

Unverified Answer

Has the FDA given its blessing for MRX-2843 to be utilized in medical treatments?

"MRX-2843 received the lowest safety rating, 1 out of 3, as this is a Phase 1 trial. This indicates that there is only minimal data so far in terms of efficacy and safety." - Anonymous Online Contributor

Unverified Answer

What is the ceiling of participants for this research endeavor?

"Affirmative. The information on clinicaltrials.gov suggests that this medical trial is actively recruiting patients - it was initially posted on April 1st 2022 and last updated on July 6th 2022. Approximately 50 individuals must be sourced from 3 distinct sites for the study to reach completion." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.