Combining TL-895 with Ruxolitinib for treating Myelofibrosis
An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of TL-895 Combined With Ruxolitinib in Janus-associated Kinase Inhibitor (JAKi) Treatment-Naïve Myelofibrosis (MF) Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib
PHASE1; PHASE2 · Telios Pharma, Inc. · NCT05280509
This study is testing if combining TL-895 with Ruxolitinib can help people with Myelofibrosis feel better, especially those who haven't responded well to Ruxolitinib alone.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Telios Pharma, Inc. (industry) |
| Drugs / interventions | ruxolitinib |
| Locations | 19 sites (Birmingham, Alabama and 18 other locations) |
| Trial ID | NCT05280509 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with Myelofibrosis who are either new to treatment or have not responded adequately to ruxolitinib.
Not a fit: Patients who have previously received any JAK inhibitor or have documented disease progression while on ruxolitinib may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with Myelofibrosis who have limited responses to existing treatments.
How similar studies have performed: Other studies have explored similar combinations, but the specific use of TL-895 with ruxolitinib in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Birmingham, Alabama and 18 other locations
- 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)
- CHU de Nice - Hopital L'Archet II — Nice, France (RECRUITING)
- Hôpital Saint Louis - AP-HP — Paris, France (RECRUITING)
- Centre Hospitalier Lyon Sud — Pierre-Bénite, France (RECRUITING)
- Marien Hospital Duesseldorf — Düsseldorf, Germany (RECRUITING)
- Klinik fur Innere Medizin IV - Hamatologie/Onkologie, Universitatsklinikum Hall — Halle, Germany (RECRUITING)
- IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola — Bologna, Italy (RECRUITING)
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano — Milan, Italy (RECRUITING)
- Azienda Ospedaliera di Perugia-Ospedale S. Maria della Misericordia — Perugia, Italy (RECRUITING)
- Pratia Onkologia Katowice — Katowice, Poland (RECRUITING)
- Hospital Universitari Arnau de Vilanova — Lleida, Spain (RECRUITING)
- Hospital Universitario Ramon y Cajal — Madrid, Spain (RECRUITING)
- Hospital Universitario Virgen de la Victoria — Málaga, Spain (RECRUITING)
- Hospital Quironsalud de Zaragoza — Zaragoza, Spain (RECRUITING)
Study contacts
- Study coordinator: John Mei
- Email: jmei@teliospharma.com
- Phone: 650-542-0136
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Myelofibrosis, Primary Myelofibrosis, Post-PV MF, Post-ET Myelofibrosis