TERMINATED

Study of SGR-2921 in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

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Conditions

Acute Myeloid LeukemiaHigh-Risk and Very High-Risk Myelodysplastic SyndromesMDSRelapsed or Refractory AML

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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

The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) and/or recommended dose (RD) of SGR-2921.

Official Title

A First-In-Human, Phase 1, Dose Escalation Study of SGR-2921 as Monotherapy In Subjects With Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Quick Facts

Study Start:2023-09-27
Study Completion:2025-09-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05961839

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 CriteriaExclusion Criteria
  1. * ≥ 18 years of age.
  2. * Life expectancy ≥ 8 weeks.
  3. * Confirmed diagnosis of R/R AML or High Risk (HR) and Very High Risk (VHR) MDS.
  4. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  1. * Active malignancies within two years prior to the first dose, or requiring ongoing treatment, not related to AML or MDS.
  2. * Clinical evidence of central nervous system (CNS) or pulmonary leukostasis, ≥ Grade 3 disseminated intravascular coagulation, or active CNS leukemia.
  3. * Use of experimental drug, or therapy, or anti-cancer therapy within 14 days or 5 half-lives of the first dose of study drug.
  4. * QT interval corrected for heart rate per Fridericia's formula ≥470 msec during screening ECG.

Contacts and Locations

Principal Investigator

Daniel Weiss, M.D.
STUDY_DIRECTOR
Schrödinger, Inc.

Study Locations (Sites)

Colorado Blood Cancer Institute
Denver, Colorado, 80218
United States
The University of Kansas Clinical Research Center
Fairway, Kansas, 66205
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
The Ohio State University Wexner Medical Center - James Cancer Hospital
Columbus, Ohio, 43210
United States
Oncology Associates of Oregon, P.C.
Eugene, Oregon, 97401
United States
Oregon Health & Science University - Knight Cancer Institute - Center of Hematologic Malignancies
Portland, Oregon, 97239
United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization
Philadelphia, Pennsylvania, 19107
United States
TriStar Bone Marrow Transplant, LLC
Nashville, Tennessee, 37203
United States
St. David's South Austin Medical Center
Austin, Texas, 78745
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Schrödinger, Inc.

  • Daniel Weiss, M.D., STUDY_DIRECTOR, Schrödinger, Inc.

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 Date2023-09-27
Study Completion Date2025-09-09

Study Record Updates

Study Start Date2023-09-27
Study Completion Date2025-09-09

Terms related to this study

Keywords Provided by Researchers

  • MDS
  • Relapsed or Refractory AML

Additional Relevant MeSH Terms

  • Acute Myeloid Leukemia
  • High-Risk and Very High-Risk Myelodysplastic Syndromes