Single agent dose escalation for Acute Myeloid Leukemia

Memorial Sloan-Kettering Cancer Center, New York, NY
Acute Myeloid Leukemia+1 More ConditionsLYT-200 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Acute Myeloid Leukemia, Adult Recurrent
  • Myelodysplastic Syndrome

Treatment Effectiveness

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: approximately 1 year

approximately 1 year
Anti-Drug Antibody formation
Incidence of Dose Limiting Toxicities [Tolerability and RP2D determination]
Incidence of Treatment-Emergent Adverse Events [Safety and RP2D determination]
Pharmacokinetic (PK) profile of LYT-200_Area Under the Curve (AUC)
Pharmacokinetic (PK) profile of LYT-200_Concentration Max (CMax)
Pharmacokinetic (PK) profile of LYT-200_Time to Reach CMax (TMax)
Rate of disease responses, time-to-event endpoints, hematological improvements

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

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

Single agent dose escalation
Drug
Experimental Group · 1 Intervention: LYT-200 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 1 year

Who is running the clinical trial?

PureTechLead Sponsor
5 Previous Clinical Trials
645 Total Patients Enrolled
Aleksandra Filipovic, MD, PhD.Study DirectorPureTech Health

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

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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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

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