Iadademstat for Leukemia, Myelocytic, Acute

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Massachusetts General Hospital (MGH), Boston, MA
Leukemia, Myelocytic, Acute+4 More
Iadademstat - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is an escalation/expansion, open label, multicenter study to investigate the safety and the RP2D of the combination of iadademstat with gilteritinib in FLT3-mutated R/R AML.

Eligible Conditions

  • Leukemia, Myelocytic, Acute

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

11 Primary · 7 Secondary · Reporting Duration: Up to 24 months

Up to 18 months
Adverse Events (AE)
Duration of Remission (DoR)
Event-Free-Survival (EFS)
Laboratory value abnormalities and/or adverse events (AE)
OR rate
Recommend Phase 2 dose (RP2D)
Routine 12-lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
Transfusion independence rate
Transplantation Rate Time Frame
Vital sign abnormalities and/or adverse events (AEs)
Up to 24 months
Overall Survival (OS)
Up to 26 days
Iadademstat Cmax
iadademstat AUC
iadademstat Cmin
iadademstat Target Engagement (TE)
iadademstat tmax
Up to 6 months
Overall response rate
Time to Response (TTR)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Active arm
1 of 1
Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: Iadademstat · No Placebo Group · Phase 1

Active armExperimental Group · 2 Interventions: Gilteritinib Oral Tablet, Iadademstat · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months
Closest Location: Massachusetts General Hospital (MGH) · Boston, MA
Photo of Boston 1Photo of Boston 2Photo of Boston 3
2017First Recorded Clinical Trial
0 TrialsResearching Leukemia, Myelocytic, Acute
9 CompletedClinical Trials

Who is running the clinical trial?

Oryzon Genomics S.A.Lead Sponsor
2 Previous Clinical Trials
180 Total Patients Enrolled
Douglas Faller, PhDStudy ChairOryzon Genomics

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a diagnosis of AML or AML-MRC.
You are positive for FLT3-ITD or FLT3-TKD in bone marrow or PB.
You have lived for at least 3 months.
You are female and postmenopausal, documented as surgically sterile, use two methods of contraception or practice true abstinence and have a negative urine pregnancy test at screening.
You are male and agree to practice true abstinence or use highly effective barrier contraception.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.