RECRUITING

Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis

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 (Cohorts 1-3) or Indolent Systemic Mastocytosis (Cohort 5). Participants must be diagnosed with Myelofibrosis and be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment, or be diagnosed with Indolent Systemic Mastocytosis.

Official Title

A Phase 2 Multicenter Study of TL-895 in Subjects With Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis, Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis, or Indolent Systemic Mastocytosis

Quick Facts

Study Start:2020-10-22
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04655118

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. * Adults ≥18 years of age
  2. * Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria
  3. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
  4. * Adequate hematologic, hepatic, and renal functions
  5. * MF symptoms as defined by having at least 2 symptoms with an average baseline (Day -7 to Day -1) score of at least 1 for each of the 2 symptoms per MFSAF v4.0
  6. * Cohort 3 only: Ineligibility for JAKi treatment with a platelet count of ≥ 25 and \< 50 x 10\^9/L
  1. * Prior treatment with any BTK or BMX inhibitors
  2. * Prior treatment with JAKi within 28 days prior to study treatment
  3. * Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment

Contacts and Locations

Study Contact

John Mei
CONTACT
650-542-0136
jmei@teliospharma.com
Emily Houlihan
CONTACT
401-954-8042
ehoulihan@teliospharma.com

Study Locations (Sites)

University of Colorado - Aurora Cancer Center
Aurora, Colorado, 80045
United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
United States
Gabrail Cancer Center
Canton, Ohio, 44718
United States
University of Cincinnati (UC) Physicians Company, LLC
Cincinnati, Ohio, 45267
United States
Ohio State University
Columbus, Ohio, 43210
United States
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 Date2020-10-22
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2020-10-22
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Myelofibrosis
  • Indolent Systemic Mastocytosis