Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 2

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

NCT04655118 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Placebo
  • DRUG TL-895

Study Locations (20)

Other

  • Border Medical Oncology — East Albury
  • Southern Oncology Specialists — Kogarah
  • Royal Perth Hospital — Perth
  • St Vincent's Hospital Sydney — Sydney
  • Chu De Liège — Liège
  • Cliniques Universitaires Saint-Luc — Woluwe-Saint-Lambert
  • Instituto de Estudos e Pesquisas Sao Lucas - IEP - Sao Lucas — São Paulo
  • University Hospital "St Ivan Rilski" — Sofia
  • Military Medical Academy — Sofia
  • CH Le Mans — Le Mans
  • CHU de Nantes - Hôtel-Dieu — Nantes
  • CHU de Nice - Hopital L' Archet II — Nice
  • Universitaetsklinikum Carl Gustav Carus Dresden — Dresden
  • Marien Hospital Duesseldorf — Düsseldorf

Ohio

  • Gabrail Cancer Center — Canton
  • University of Cincinnati (UC) Physicians Company, LLC — Cincinnati
  • Ohio State University — Columbus

Colorado

  • University of Colorado - Aurora Cancer Center — Aurora

Minnesota

  • Mayo Clinic - Rochester — Rochester

Texas

  • University of Texas, MD Anderson Cancer Center — Houston

Trial Details

FieldValue
Enrollment Target 121 participants
Start Date 2020-10-22
Est. Completion 2025-12-31
Phase Phase 2

Sponsor

Telios Pharma

37 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04655118

The ClinicalTrials.gov registry entry for NCT04655118 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 121 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Telios Pharma, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Myelofibrosis appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04655118 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Other, Ohio, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04655118 about?

NCT04655118 is a clinical study titled "Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis". 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., havin...

What is the current status of trial NCT04655118?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 121 participants. The study started on 2020-10-22. Estimated completion is 2025-12-31.

What conditions does trial NCT04655118 study?

This clinical trial studies the following conditions: Myelofibrosis, Indolent Systemic Mastocytosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04655118?

The interventions under investigation include: Placebo (DRUG), TL-895 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04655118?

This trial is sponsored by Telios Pharma, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04655118 being conducted?

This trial has 20 study locations across Colorado, Minnesota, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial