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Recruiting NCT05280509

Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib

Phase I / Phase II Interventional Myelofibrosis Primary Myelofibrosis Post-PV MF Post-ET Myelofibrosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TL-895, Ruxolitinib.
Who it may be relevant to
Registry conditions: Myelofibrosis, Primary Myelofibrosis, Post-PV MF, Post-ET Myelofibrosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, France, Germany, Italy, Poland +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug TL-895
    TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
  • Drug Ruxolitinib
    Ruxolitinib is an FDA-approved janus kinase inhibitor anticancer drug taken by mouth.

Primary outcome measures

  • Phase 1b - Recommended Phase 2 dose of TL-895 in combination with ruxolitinib [Time frame: 28 days]
  • Phase 2 - Spleen Volume Reduction (SVR) at Week 24 [Time frame: 24 Weeks]
Secondary outcome measures (6)
  • Phase 1b - Spleen Volume Reduction (SVR) at Week 24 [Time frame: 24 Weeks]
  • Phase 1b - TSS reduction at Week 24 [Time frame: 24 Weeks]
  • Phase 2 - TSS reduction at Week 24 [Time frame: 24 Weeks]
  • DOR Spleen [Time frame: 48 Months]
  • Progression Free Survival [Time frame: 48 Month]
  • Overall Survival [Time frame: 48 Months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 5 centers
  • CHU Angers — Angers
  • AP-HM - Hôpital de la Timone — Marseille
  • CHU de Nice - Hopital L'Archet II — Nice
  • Hôpital Saint Louis - AP-HP — Paris
  • Centre Hospitalier Lyon Sud — Pierre-Bénite
United States · 4 centers
  • University of Alabama at Birmingham — Birmingham
  • Gabrail Cancer Center — Canton
  • University of Cincinnati (UC) — Cincinnati
  • The University of Texas MD Anderson Cancer Center — Houston
Spain · 4 centers
  • Hospital Universitari Arnau de Vilanova — Lleida
  • Hospital Universitario Ramon y Cajal — Madrid
  • Hospital Universitario Virgen de la Victoria — Málaga
  • Hospital Quironsalud de Zaragoza — Zaragoza
Italy · 3 centers
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola — Bologna
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano — Milan
  • Azienda Ospedaliera di Perugia-Ospedale S. Maria della Misericordia — Perugia
Germany · 2 centers
  • Marien Hospital Duesseldorf — Düsseldorf
  • Klinik fur Innere Medizin IV - Hamatologie/Onkologie, Universitatsklinikum Hall — Halle
Poland · 1 center
  • Pratia Onkologia Katowice — Katowice

Identifiers

NCT: NCT05280509 · TL-895-209

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗