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Taking people in FrancePhase 1/2

Tests TL-895 with ruxolitinib in adults with myelofibrosis

Tests TL-895 combined with ruxolitinib in adults with myelofibrosis, a bone marrow disease.

Key facts

Who runs it
Telios Pharma, Inc.
Where
Angers, Marseille, Nice, Paris, and Pierre-Bénite, FranceSee the 5 sitesAlso in 5 other countries, 14 sites
Trial code
Registry title
Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib
Status
Recruiting
Phase
Phase 1/2
People taking part
70 people, planned
Started
9 Jun 2022
Expected to end
Apr 2027
Type of study
Interventional, 5 groups
Treatments tested
  • TL-895
  • Ruxolitinib
Record updated
21 February 2023

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with myelofibrosis (primary, post-PV or post-ET) who have not had a JAK inhibitor before, or who respond only partly to ruxolitinib.

Age
18 years or older
Sex
All sexes can join
Disease stage
Primary myelofibrosis, post-PV MF or post-ET MF. High-risk, intermediate-2 or intermediate-1 risk by DIPSS. Enlarged spleen: palpable 5 cm (2 in) or more below the left lower coastal margin, or spleen volume 450 cm3 or more on MRI or CT. ECOG performance status 0 to 2.
Earlier treatment
Two groups can join: people who never had a JAK inhibitor, and people on a stable dose of ruxolitinib with a suboptimal response. People who had a BTK or BMX inhibitor cannot join.

Main reasons for not taking part

  • Earlier treatment with any JAK inhibitor (for the treatment-naive group)
  • Disease getting worse while on ruxolitinib
  • Spleen removal or spleen radiation within 24 weeks before the first dose
  • Earlier treatment with a BTK or BMX inhibitor

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Prior treatment with any JAKi; Subjects with suboptimal response to ruxolitinib:
  • Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment
  • Prior treatment with a BTK or BMX inhibitor
  • Documented disease progression while on ruxolitinib treatment; All subjects:
  • Treatment-naive subjects:

Where in France

Also in 5 other countries, 14 sites

  • CHU AngersAngers, FranceContact: John MeiTaking people
  • AP-HM - Hopital de la TimoneMarseille, FranceContact: John MeiTaking people
  • CHU de Nice - Hopital L'Archet IINice, FranceContact: John MeiTaking people
  • Hôpital Saint Louis - AP-HPParis, FranceContact: John MeiTaking people
  • Centre Hospitalier Lyon-SudPierre-Bénite, FranceContact: John MeiTaking people

About the trial

What the trial wants to find out

This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must have MF (PMF, Post PV MF, or Post ET MF) who are JAKi treatment-naïve or those who have a suboptimal response to ruxolitinib.

The 5 groups in the trial

  • Phase 1b - Dose Level 1Treatment being tested

    150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle combined with the subject's pre-study stable dose of ruxolitinib.

    Treatment: TL-895 and Ruxolitinib

  • Phase 1b - Dose Level 2Treatment being tested

    300 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle combined with the subject's pre-study stable dose of ruxolitinib.

    Treatment: TL-895 and Ruxolitinib

  • Phase 1b - Dose Level 3Treatment being tested

    450 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle combined with the subject's pre-study stable dose of ruxolitinib.

    Treatment: TL-895 and Ruxolitinib

  • Phase 2 - Cohort 1 JAKi treatment-naïve MFTreatment being tested

    The RP2D of TL-895 as determined in Phase 1b will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle. The dose of ruxolitinib will be based on the subject's baseline platelet count.

    Treatment: TL-895 and Ruxolitinib

  • Phase 2 - Cohort 2 suboptimal response to RuxolitinibTreatment being tested

    The RP2D of TL-895 as determined in Phase 1b will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle. The dose schedule will be the stable ruxolitinib dose schedule as the subject is currently taking prior to entry into the study.

    Treatment: TL-895 and Ruxolitinib

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Tests TL-895 with ruxolitinib in adults with myelofibrosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
21 February 2023