RECRUITING

Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis

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 either KRT-232 or TL-895 in treatment naïve patients with myelofibrosis (MF) The study will be conducted in 2 stages. Stage 1 will evaluate safety, tolerability, and efficacy of either KRT-232 (Arm 1) or TL-895 (Arm 2) in treatment naïve patients. Stage 2 will expand enrollment in Arm 1 and/or Arm 2 if expansion criteria is met.

Official Title

An Open-Label, Multicenter, Phase 2 Study Assessing the Safety and Efficacy of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis

Quick Facts

Study Start:2021-04-13
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04878003

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. * Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
  2. * High-risk, or intermediate-1 and 2 risk, defined by Dynamic International Prognostic System (DIPSS)
  3. * ECOG of 0 or 1
  1. * Subjects who are positive for p53 mutation (Arm 1)
  2. * Prior MDM2 inhibitor therapy or p53-directed therapy (Arm 1)
  3. * Prior treatment with any JAK inhibitor
  4. * Prior splenectomy
  5. * Splenic irradiation within 24 weeks prior to randomization
  6. * Prior allogeneic stem-cell transplantation or plans for allogeneic stem-cell transplant
  7. * History of major organ transplant
  8. * Grade 2 or higher QTc prolongation
  9. * Major hemorrhage or intracranial hemorrhage within 24 weeks prior to randomization

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Innovative Clinical Research Institute
Glendale, California, 90603
United States
Innovative Clinical Research Institute
Whittier, California, 90603
United States
Gabrail Cancer Center
Canton, Ohio, 44718
United States
MD Anderson Cancer Center
Houston, Texas, 77030
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 Date2021-04-13
Study Completion Date2025-10

Study Record Updates

Study Start Date2021-04-13
Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

  • navtemadlin

Additional Relevant MeSH Terms

  • Primary Myelofibrosis (PMF)
  • Post-Polycythemia Vera Myelofibrosis (Post-PV-MF)
  • Post-Essential Thrombocythemia Myelofibrosis (Post-ET-MF)