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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
Ruxolitinib is an FDA-approved janus kinase inhibitor anticancer drug taken by mouth.
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGGabrail Cancer Center
Canton, Ohio, United States
RECRUITINGUniversity of Cincinnati (UC)
Cincinnati, Ohio, United States
RECRUITINGThe University of Texas MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGCHU Angers
Angers, France
RECRUITINGAP-HM - Hôpital de la Timone
Marseille, France
RECRUITINGCHU de Nice - Hopital L'Archet II
Nice, France
RECRUITINGHôpital Saint Louis - AP-HP
Paris, France
RECRUITINGCentre Hospitalier Lyon Sud
Pierre-Bénite, France
RECRUITINGMarien Hospital Duesseldorf
Düsseldorf, Germany
RECRUITING...and 9 more locations
Phase 1b - Recommended Phase 2 dose of TL-895 in combination with ruxolitinib
Dose-limiting toxicities (DLTs) will be used to establish the maximum-tolerated dose (MTD) of TL-895 in combination with ruxolitinib. The safety review committee (SRC) will determine the RP2D based on safety and efficacy data of the combination of TL-895 and ruxolitinib.
Time frame: 28 days
Phase 2 - Spleen Volume Reduction (SVR) at Week 24
The proportion of subjects achieving SVR of ≥35% at Week 24 by magnetic resonance imaging (MRI) or computed tomography (CT) scan.
Time frame: 24 Weeks
Phase 1b - Spleen Volume Reduction (SVR) at Week 24
The proportion of subjects achieving ≥35% SVR at Week 24 by MRI or CT scan.
Time frame: 24 Weeks
Phase 1b - TSS reduction at Week 24
The proportion of subjects achieving ≥50% reduction in TSS at Week 24 by Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.
Time frame: 24 Weeks
Phase 2 - TSS reduction at Week 24
The proportion of subjects achieving ≥50% reduction in TSS at Week 24 by MFSAF v4.0.
Time frame: 24 Weeks
DOR Spleen
Time from initial SVR of ≥ 35% by MRI/CT until the first occurrence of disease progression or death
Time frame: 48 Months
Progression Free Survival
Time from first dose to progression or death from any cause.
Time frame: 48 Month
Overall Survival
Time from first dose to death from any cause
Time frame: 48 Months
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