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LYT-200 for Acute Myeloid Leukemia and Preleukemia

Phase 1

Recruiting

Research Sponsored by PureTech

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 approximately 1 year

Awards & highlights

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.

Who is the study for?

This trial is for adults over 18 with relapsed/refractory Acute Myeloid Leukemia or high-risk Myelodysplastic Syndrome, who've tried at least one treatment without success and have no other beneficial standard treatments available. Participants must be able to perform daily activities with relative ease (ECOG ≤ 2) and meet specific health criteria like a certain white blood cell count and organ function.Check my eligibility

What is being tested?

LYT-200, a new potential therapy, is being tested in this Phase 1 trial for safety, how the body processes it (pharmacokinetics), and its effectiveness against AML/MDS. The study involves patients receiving LYT-200 to evaluate these aspects in those with advanced forms of these blood disorders.See study design

What are the potential side effects?

As this is an early-phase trial testing LYT-200's safety profile, side effects are currently under investigation. Common side effects from similar therapies may include nausea, fatigue, increased risk of infection due to low blood counts, liver enzyme elevations, and potential infusion-related reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of Dose Limiting Toxicities [Tolerability and RP2D determination]

Incidence of Treatment-Emergent Adverse Events [Safety and RP2D determination]

Secondary outcome measures

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)

+1 more

Other outcome measures

Anti-Drug Antibody formation

Trial Design

2Treatment groups

Experimental Treatment

Group I: Single agent dose escalationExperimental Treatment1 Intervention

LYT-200 in relapsed/refractory AML or relapsed/refractory high-risk MDS, administered via IV infusion over 60 minutes every week.

Group II: Combination agent dose escalationExperimental Treatment4 Interventions

LYT-200 in relapsed/refractory AML or relapsed/refractory high-risk MDS, administered via IV infusion over 60 minutes every week, in combination with oral venetoclax Day 1, 100 mg, Day 2, 200mg, Day 3-28, 400 mg and/or azacitidine, 75 mg/m2 subcutaneously given for 7 days per cycle or decitabine 20 mg/m2 IV for 5 days per cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Decitabine

2004

Completed Phase 3

~1680

Venetoclax

2019

Completed Phase 3

~1990

Azacitidine

2012

Completed Phase 3

~1440

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

PureTechLead Sponsor

5 Previous Clinical Trials

741 Total Patients Enrolled

Aleksandra Filipovic, MD, PhD.Study DirectorPureTech Health

Media Library

LYT-200 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05829226 — Phase 1

Acute Myeloid Leukemia Research Study Groups: Combination agent dose escalation, Single agent dose escalation

Acute Myeloid Leukemia Clinical Trial 2023: LYT-200 Highlights & Side Effects. Trial Name: NCT05829226 — Phase 1

LYT-200 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05829226 — Phase 1

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 1 Study With LYT-200 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML), or With Relapsed/Refractory, High-risk Myelodysplastic Syndrome (MDS)

2022. "A Phase 1 Study With LYT-200 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML), or With Relapsed/Refractory, High-risk Myelodysplastic Syndrome (MDS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05829226.