RECRUITING

KRT-232 and TKI Study in Chronic Myeloid Leukemia

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

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor (TKI). This study is a global, open label Phase 1b/2 to determine the efficacy and safety of KRT-232 in patients with chronic phase CML (CML-CP) and accelerated phase (CML-AP) who have failed TKI treatments.

Official Title

An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With a Tyrosine Kinase Inhibitor (TKI) in Patients With Relapsed or Refractory Ph+ Chronic Myeloid Leukemia (CML)

Quick Facts

Study Start:2021-05-07
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04835584

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. * Phase 1b and Phase 2 Arms A and B: Documented TP53wt, Ph+, BCR-ABL+ CML-CP
  2. * Phase 2 Arm C ONLY: Documented TP53wt, Ph+, BCR-ABL+ CML-AP
  3. * Subject is resistant (relapsed or refractory) and/or intolerant to at least 1 prior TKI.
  4. * Adults ≥ 18 years of age.
  5. * ECOG performance status of 0 to 2
  6. * Adequate hematologic, hepatic, and renal functions
  1. * Phase 1b and Phase 2 Arms A and B: Documented Ph+, BCR-ABL+ CML-AP
  2. * Documented Ph+, BCR-ABL+ CML-BC
  3. * Known T315I mutation.
  4. * Prior treatment with MDM2 antagonist therapies.
  5. * Intolerance to current TKI therapy.

Contacts and Locations

Study Contact

John Mei
CONTACT
650-542-0136
jmei@kartosthera.com

Study Locations (Sites)

University of Alabama Birmingham
Birmingham, Alabama, 35294
United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
United States
Texas Oncology- Sammons CC at Baylor
Dallas, Texas, 75246
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Kartos Therapeutics, 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 Date2021-05-07
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2021-05-07
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • navtemadlin

Additional Relevant MeSH Terms

  • Chronic Myeloid Leukemia