Actively Recruiting
Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib
Led by Telios Pharma, Inc. · Updated on 2023-02-21
70
Participants Needed
19
Research Sites
251 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older able to provide informed consent
- Confirmed diagnosis of primary MF, post-PV MF, or post-ET MF by World Health Organization criteria
- Classified as high-risk, intermediate-2, or intermediate-1 risk by the Dynamic International Prognostic System
- Palpable spleen at least 5 cm below the left lower rib margin or spleen volume of 450 cm3 or greater by MRI or CT
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate blood, liver, and kidney function
- For suboptimal responders: stable dose of ruxolitinib before study entry
You will not qualify if you...
- Prior treatment with any Janus-associated kinase inhibitor (JAKi) for treatment-naive subjects
- Documented disease progression while on ruxolitinib for suboptimal responders
- Prior splenectomy or splenic irradiation within 24 weeks before starting study treatment
- Previous treatment with a BTK or BMX inhibitor
AI-Screening
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Trial Site Locations
Total: 19 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Actively Recruiting
3
University of Cincinnati (UC)
Cincinnati, Ohio, United States, 45267
Actively Recruiting
4
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
5
CHU Angers
Angers, France, 49100
Actively Recruiting
6
AP-HM - Hôpital de la Timone
Marseille, France, 13005
Actively Recruiting
7
CHU de Nice - Hopital L'Archet II
Nice, France, 06200
Actively Recruiting
8
Hôpital Saint Louis - AP-HP
Paris, France, 75010
Actively Recruiting
9
Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69495
Actively Recruiting
10
Marien Hospital Duesseldorf
Düsseldorf, Germany, 40479
Actively Recruiting
11
Klinik fur Innere Medizin IV - Hamatologie/Onkologie, Universitatsklinikum Hall
Halle, Germany, 40479
Actively Recruiting
12
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
Bologna, Italy, 40138
Actively Recruiting
13
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan, Italy, 20122
Actively Recruiting
14
Azienda Ospedaliera di Perugia-Ospedale S. Maria della Misericordia
Perugia, Italy, 06129
Actively Recruiting
15
Pratia Onkologia Katowice
Katowice, Poland, 40-519
Actively Recruiting
16
Hospital Universitari Arnau de Vilanova
Lleida, Spain, 25198
Actively Recruiting
17
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
18
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Actively Recruiting
19
Hospital Quironsalud de Zaragoza
Zaragoza, Spain, 50006
Actively Recruiting
Research Team
J
John Mei
CONTACT
N
Nikki Stuart
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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