RECRUITING

KRT-232 in Combination With TL-895 for the Treatment of R/R MF and KRT-232 for the Treatment of JAKi Intolerant MF

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Conditions

MyelofibrosisPost-PV MFPost-ET MyelofibrosisPrimary MyelofibrosisRelapsed/Refractory MyelofibrosisJanus associated Kinase Inhibitor-Intolerant MyelofibrosisMDM2navtemadlin

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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

This study evaluates KRT-232 in Combination With TL-895 for the Treatment of Relapsed or Refractory Myelofibrosis and KRT-232 for the Treatment of JAK Inhibitor Intolerant Myelofibrosis.

Official Title

An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 in Combination With TL-895 for the Treatment of Relapsed or Refractory Myelofibrosis and KRT-232 for the Treatment of JAK Inhibitor Intolerant Myelofibrosis.

Quick Facts

Study Start:2020-11-17
Study Completion:2025-07-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04640532

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 primary MF, post-PV MF, or post-ET MF, (WHO 2016)
  2. * ECOG ≤ 2
  3. * Cohort 1 and Cohort 2: R/R following JAK inhibitor treatment
  4. * Cohort 3: patients who are intolerant to JAK inhibitor treatment
  1. * Prior treatment with MDM2 inhibitors or p53-directed therapies
  2. * Prior treatment with a BCR-ABL, phosphoinositide 3-kinase (PI3k), mammalian target of rapamycin (mTOR), bromodomain and extraterminal domain (BET), histone deacetylase (HDAC), or spleen tyrosine kinase (Syk) inhibitor
  3. * Prior splenectomy
  4. * Splenic irradiation within 3 months prior to the first dose of study treatment
  5. * Clinically significant thrombosis within 3 months of screening
  6. * Grade 2 or higher QTc prolongation

Contacts and Locations

Study Contact

John Mei
CONTACT
650-542-0136
jmei@kartosthera.com
Irene Dea
CONTACT
(650) 839-7341
idea@kartosthera.com

Study Locations (Sites)

University of Alabama at Birmingham School of Medicine, Division of Hematology and Oncology
Birmingham, Alabama, 35233
United States
The Oncology Institute of Hope
Whittier, California, 90603
United States
Lake City Cancer Center
Lake City, Florida, 32024
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
Columbia University Medical Center
Fort Lee, New Jersey, 07024
United States
Memorial Sloan Kettering Cancer Center (MSKCC)
New York, New York, 10065
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 Date2020-11-17
Study Completion Date2025-07-24

Study Record Updates

Study Start Date2020-11-17
Study Completion Date2025-07-24

Terms related to this study

Keywords Provided by Researchers

  • Relapsed/Refractory Myelofibrosis
  • Janus associated Kinase Inhibitor-Intolerant Myelofibrosis
  • MDM2
  • navtemadlin

Additional Relevant MeSH Terms

  • Myelofibrosis
  • Post-PV MF
  • Post-ET Myelofibrosis
  • Primary Myelofibrosis