RECRUITING

Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib

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 TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must have MF (PMF, Post PV MF, or Post ET MF) who are JAKi treatment-naïve or those who have a suboptimal response to ruxolitinib.

Official Title

An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of TL-895 Combined With Ruxolitinib in Janus-associated Kinase Inhibitor (JAKi) Treatment-Naïve Myelofibrosis (MF) Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib

Quick Facts

Study Start:2022-06-09
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05280509

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. * Treatment with at a stable dose of ruxolitinib prior to study entry
  2. * Subjects ≥ 18 years of age and able to provide informed consent.
  3. * Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria
  4. * High-risk, intermediate-2 risk, or intermediate-1 risk, defined by Dynamic International Prognostic System (DIPSS)
  5. * Palpable spleen measuring ≥ 5 cm below the left lower coastal margin (LLCM) or spleen volume of ≥ 450 cm3 by MRI or CT scan assessment
  6. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  7. * Adequate hematological, hepatic, \& renal function.
  1. * Prior treatment with any JAKi
  2. * Documented disease progression while on ruxolitinib treatment
  3. * Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment
  4. * Prior treatment with a BTK or BMX inhibitor

Contacts and Locations

Study Contact

John Mei
CONTACT
650-542-0136
jmei@teliospharma.com
Nikki Stuart
CONTACT
nzona@teliospharma.com

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Gabrail Cancer Center
Canton, Ohio, 44718
United States
University of Cincinnati (UC)
Cincinnati, Ohio, 45267
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Telios Pharma, 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 Date2022-06-09
Study Completion Date2027-04

Study Record Updates

Study Start Date2022-06-09
Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

  • Myelofibrosis

Additional Relevant MeSH Terms

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