Combining TL-895 with Ruxolitinib for treating Myelofibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of TL-895, a selective tyrosine kinase inhibitor, in patients with Myelofibrosis who are either treatment-naïve or have shown a suboptimal response to ruxolitinib. Participants must have a confirmed diagnosis of primary Myelofibrosis, post-PV Myelofibrosis, or post-ET Myelofibrosis, and meet specific risk criteria. The study aims to assess the safety and efficacy of this combination therapy in improving patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Subjects with suboptimal response to ruxolitinib:

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

Exclusion Criteria:

Treatment-naive subjects:

* Prior treatment with any JAKi

Subjects with suboptimal response to ruxolitinib:

* Documented disease progression while on ruxolitinib treatment

All subjects:

* Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment
* Prior treatment with a BTK or BMX inhibitor

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Gabrail Cancer Center
  Canton, Ohio, United States Recruiting
• University of Cincinnati (UC)
  Cincinnati, Ohio, United States Recruiting
• The University of Texas MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• CHU Angers
  Angers, France Recruiting
• AP-HM - Hôpital de la Timone
  Marseille, France Recruiting

Study contacts

• Study coordinator: John Mei
• Email: jmei@teliospharma.com
• Phone: 650-542-0136

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Adding navtemadlin to ruxolitinib for myelofibrosis patients with poor response

  This study is testing if adding a new drug called navtemadlin to ruxolitinib can help myelofibrosis patients who aren't doing well on ruxolitinib alone.

  Recruiting at 214 sites Phase 3 Kartos Therapeutics, Inc. · Birmingham, Alabama and 214 other locations · NCT06479135

• MPN PROGRESSion Registry — tracking symptoms, treatments, and disease progression in people with MPNs.

  Track long-term symptoms, treatments, and disease progression in adults with myeloproliferative neoplasms to see how these conditions evolve over time.

  Recruiting at 2 sites MPN Research Foundation · Chicago, Illinois and 1 other locations · NCT07362225

• National registry for people with myelofibrosis and anemia in Germany.

  This project will collect health, treatment, and quality-of-life information from people in Germany with primary or secondary myelofibrosis and anemia to see how their care and symptoms change over time.

  Recruiting iOMEDICO AG · Multiple Locations · NCT06976918

• Combining Momelotinib and Luspatercept for Myelofibrosis Treatment

  This study is testing if combining two medications, momelotinib and luspatercept, can help people with myelofibrosis who need blood transfusions feel better and reduce their transfusion needs.

  Recruiting at 33 sites Phase 2 GlaxoSmithKline · Ann Arbor, Michigan and 32 other locations · NCT06517875

• Observational study on ruxolitinib for myelofibrosis patients

  This study looks at how well ruxolitinib works for people with myelofibrosis and how different factors affect their long-term survival.

  Recruiting at 26 sites IRCCS Azienda Ospedaliero-Universitaria di Bologna · Cosenza, Calabria and 25 other locations · NCT06516406

• Evaluating DISC-0974 for treating anemia in myelofibrosis patients

  This study tests if a new treatment called DISC-0974 can help people with myelofibrosis who have anemia feel better and improve their condition.

  Recruiting at 33 sites Phase 1/2 Disc Medicine, Inc · Gilbert, Arizona and 34 other locations · NCT05320198

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.