Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2020-10-22 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
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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.
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