RECRUITING

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)

Conditions

AML, Adult Recurrent MDS AML Recurrent AML Relapsed AML Refractory Hematological Cancer Gal-9 Immuno-oncology MDS High Risk

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A Phase 1 Open-label, Multi-center Study of the Safety, Pharmacokinetics (PK), and Anti-tumor Activity of LYT- 200 in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML), or with Relapsed/refractory, High-risk Myelodysplastic Syndrome (MDS)

Official Title

A Phase 1 Open-label, Multi-center Study of the Safety, Pharmacokinetics (PK), and Anti-tumor Activity of LYT- 200 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML), or With Relapsed/Refractory, High-risk Myelodysplastic Syndrome (MDS)

Quick Facts

Study Start:2022-12-12

Study Completion:2025-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05829226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients ≥ 18 years of age at the time of obtaining informed consent. * Patients with morphologically documented primary or secondary AML by the World Health Organization(WHO) criteria, whose disease is relapsed/refractory to at least one line of prior therapy, with or without an allogeneic stem cell transplant and for whom no standard therapy that may provide clinical benefit is available or for patients who decline available standard of care. * Patients with a documented diagnosis of high-risk myelodysplastic syndrome (MDS), whose disease is relapsed/refractory, post at least one line of treatment based on the revised International Prognostic Scoring System (IPSS-R) and for whom no standard therapy that may provide clinical benefit is available * Patients are able and willing to comply with study procedures as per protocol, including bone marrowbiopsies. * Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. * Patient must meet the following criteria as indicated on the clinical laboratory tests:	* Patient diagnosed with acute promyelocytic leukemia (APL). * Patient has active malignant tumors other than AML/MDS * Patient has had HSCT and meets any of the following: has undergone HSCT within the 6- month period prior to the first study dose; has ≥ Grade 2 persistent non-hematological toxicity related to the transplant donor lymphocytes infusion. * Patient has active graft versus host disease (GVHD) and patients receiving immunosuppressive treatment for GVHD. * Patient with symptomatic central nervous system (CNS) involvement of leukemia or other CNS diseases related to underlying and secondary effects of malignancy * Patient has had major surgery within 4 weeks prior to the first study dose. * Patient has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patient with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multigated acquisition (MUGA) scan performed within 3 months prior to study entry results in a left ventricular ejection fraction (LVEF) that is ≥ 45%. * Patient has any condition which, in the Investigator's opinion, makes the patient unsuitable for study participation.

Inclusion Criteria

Exclusion Criteria

* Patients ≥ 18 years of age at the time of obtaining informed consent.
* Patients with morphologically documented primary or secondary AML by the World Health Organization(WHO) criteria, whose disease is relapsed/refractory to at least one line of prior therapy, with or without an allogeneic stem cell transplant and for whom no standard therapy that may provide clinical benefit is available or for patients who decline available standard of care.
* Patients with a documented diagnosis of high-risk myelodysplastic syndrome (MDS), whose disease is relapsed/refractory, post at least one line of treatment based on the revised International Prognostic Scoring System (IPSS-R) and for whom no standard therapy that may provide clinical benefit is available
* Patients are able and willing to comply with study procedures as per protocol, including bone marrowbiopsies.
* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
* Patient must meet the following criteria as indicated on the clinical laboratory tests:

* Patient diagnosed with acute promyelocytic leukemia (APL).
* Patient has active malignant tumors other than AML/MDS
* Patient has had HSCT and meets any of the following: has undergone HSCT within the 6- month period prior to the first study dose; has ≥ Grade 2 persistent non-hematological toxicity related to the transplant donor lymphocytes infusion.
* Patient has active graft versus host disease (GVHD) and patients receiving immunosuppressive treatment for GVHD.
* Patient with symptomatic central nervous system (CNS) involvement of leukemia or other CNS diseases related to underlying and secondary effects of malignancy
* Patient has had major surgery within 4 weeks prior to the first study dose.
* Patient has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patient with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multigated acquisition (MUGA) scan performed within 3 months prior to study entry results in a left ventricular ejection fraction (LVEF) that is ≥ 45%.
* Patient has any condition which, in the Investigator's opinion, makes the patient unsuitable for study participation.

Contacts and Locations

Study Contact

Chris Korth

CONTACT

617-982-2550

clinicaltrials@puretechhealth.com

Aleksandra Filipovic, MD, PhD.

CONTACT

617-982-2550

clinicaltrials@puretechhealth.com

Principal Investigator

Aleksandra Filipovic, MD, PhD.

STUDY_DIRECTOR

PureTech Health

Study Locations (Sites)

Cedars-Sinai Medical Center

Los Angeles, California, 90048

United States

University of California Irvine Medical Center

Orange, California, 92868

United States

Baptist Health South Florida-Miami Cancer Institute

Miami, Florida, 02114

United States

Norton Healthcare-Norton Cancer Institute

Louisville, Kentucky, 40207

United States

Mass. General Hospital-Harvard

Boston, Massachusetts, 02114

United States

Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901

United States

Rhode Island Hospital

Providence, Rhode Island, 02903

United States

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23219

United States

Collaborators and Investigators

Sponsor: PureTech

Aleksandra Filipovic, MD, PhD., STUDY_DIRECTOR, PureTech Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-12

Study Completion Date2025-05

Study Record Updates

Study Start Date2022-12-12

Study Completion Date2025-05

Terms related to this study

Keywords Provided by Researchers

AML Recurrent
AML Relapsed
AML Refractory
Hematological Cancer
Gal-9
Immuno-oncology
MDS
MDS High Risk

Additional Relevant MeSH Terms

AML, Adult Recurrent
MDS