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NCT04655118RECRUITINGIRB Ready

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

Sponsored by Telios Pharma, Inc.

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
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1 of 121 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

Adults โ‰ฅ18 years of age
Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria
Eastern Cooperative Oncology Group (ECOG) performance status of โ‰ค2
Adequate hematologic, hepatic, and renal functions
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
Cohort 3 only: Ineligibility for JAKi treatment with a platelet count of โ‰ฅ 25 and \< 50 x 10\^9/L Key

Exclusion Criteria

Prior treatment with any BTK or BMX inhibitors
Prior treatment with JAKi within 28 days prior to study treatment
Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment Cohort 5 Key Inclusion Criteria:
Adults โ‰ฅ18 years of age
Confirmed diagnosis of ISM as defined by WHO diagnostic criteria based on review of bone marrow bio

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

121 participants

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Gender

ALL

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Sponsor

Telios Pharma, Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

COMPLETED

Aurora

Colorado

Location available
View Aurora location page
RECRUITING

Rochester

Minnesota

Location available
View Rochester location page
COMPLETED

Canton

Ohio

Location available
View Canton location page
ACTIVE_NOT_RECRUITING

Cincinnati

Ohio

Location available
View Cincinnati location page
ACTIVE_NOT_RECRUITING

Columbus

Ohio

Location available
View Columbus location page
RECRUITING

Houston

Texas

Location available
View Houston location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Myelofibrosis Treatment in Aurora?

Join others in Colorado exploring innovative treatment options through clinical research

Myelofibrosis Treatment Options in Aurora, Colorado

If you're searching for Myelofibrosis treatment in Aurora, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Aurora, Rochester, Canton and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Myelofibrosis. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Colorado
Now Enrolling
Up to 121 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Myelofibrosis?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Myelofibrosis

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Myelofibrosis Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT04655118. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.