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NCT05280509 | RECRUITING | Myelofibrosis

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

Teleos Pharma, this.

Brief Summary:

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.

Condition or disease

Myelofibrosis

Primary Myelofibrosis

Post-PV MF

Post-and myelofibrosis

Intervention/treatment

TL-895

Ruxolitinib

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 70 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2022-06-09
Estimated Primary Completion Date : 2025-10
Estimated Study Completion Date : 2027-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib

Location Details

NCT05280509

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Albama

University of Alabama at Birmingham

Birmingham, Albama, United States, 35294

RECRUITING

United States, Ohio

Gabrail Cancer Center

Canton, Ohio, United States, 44718

RECRUITING

United States, Ohio

University of Cincinnati (UC)

Cincinnati, Ohio, United States, 45267

RECRUITING

United States, Texas

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

France,

CHU Angers

Angers, France, 49100

RECRUITING

France,

AP -HM - Timone Hospital

Marseille, France, 13005

RECRUITING

France,

CHU de Nice - HOPITAL L'Archet II

Nice, France, 06200

RECRUITING

France,

Saint Louis Hospital - AP -HP

Paris, France, 75010

RECRUITING

France,

Lyon South Hospital Center

Pierre-Bénite, France, 69495

RECRUITING

Germany,

Marien Hospital Duesseldorf

Düsseldorf, Germany, 40479

RECRUITING

Germany,

Clinic of Internal Medicine II - Hematology/Oncology, University Hospital Hall

Halle, Germany, 40479

RECRUITING

Italy,

IRCCS Hospital -University of Bologna - Polyclinic of Sant'Orsola

Bologna, Italy, 40138

RECRUITING

Italy,

IRCCS Foundation Ca 'Granda Maggiore Policlinico Hospital of Milan

Milano, Italy, 20122

RECRUITING

Italy,

Hospital of Perugia-Hospital S. Maria della Misericordia

Perugia, Italy, 06129

RECRUITING

Poland,

Pratia oncology Katowice

Katowice, Poland, 40-519

RECRUITING

Spain,

Arnau de Vilanova University Hospital

Lleida, Spain, 25198

RECRUITING

Spain,

Ramon and Cajal University Hospital

Madrid, Spain, 28034

RECRUITING

Spain,

Virgen de la Victoria University Hospital

Málaga, Spain, 29010

RECRUITING

Spain,

Zaragoza Quironsalud Hospital

Zaragoza, Spain, 50006