Study Summary
This trial studies the safety, PK, and anti-tumor activity of a drug in patients with relapsed/refractory AML or high-risk MDS.
- Acute Myeloid Leukemia, Adult Recurrent
- Myelodysplastic Syndrome
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
2 Primary · 4 Secondary · Reporting Duration: approximately 1 year
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
1 Treatment Group
Single agent dose escalation
1 of 1
Experimental Treatment
50 Total Participants · 1 Treatment Group
Primary Treatment: Single agent dose escalation · No Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Is enrollment in the trial currently open to qualified applicants?
"Per information on clinicaltrials.gov, this research is presently recruiting participants. The study first appeared online on December 12th 2022 and was recently edited April 12th 2023." - Anonymous Online Contributor
What potential risks exist with Single agent dose escalation therapies?
"Due to its Phase 1 status, the safety of single agent dose escalation was assessed at a score of 1 due to limited data concerning efficacy and safety." - Anonymous Online Contributor
To what degree is this experiment being populated by participants?
"PureTech, the trial's sponsor, requires 50 eligible patients to initiate this study. Subjects will be recruited from Cedars-Sinai Medical Center in Orange, Florida and University of California Irvine Medical Center in Miami, Kentucky among other locations." - Anonymous Online Contributor
At how many sites are the research participants being recruited?
"This trial is currently taking place at 17 medical sites, most notably Cedars-Sinai Medical Center in Orange, Florida; University of California Irvine Medical Center in Miami, Kentucky; and Baptist Health South Florida-Miami Cancer Institute in Shelbyville, Massachusetts." - Anonymous Online Contributor
What are the principal aims of this investigation?
"PureTech, the sponsor of this trial, announced that primary outcomes will be monitored for roughly a year and include Incidence of Dose Limiting Toxicities [Tolerability and RP2D determination]. Additionally, secondary objectives are to measure the Pharmacokinetic (PK) profile of LYT-200_Area Under the Curve (AUC), Concentration Max (CMax), and Time to Reach CMax (TMax)." - Anonymous Online Contributor