TL-895-201


A Phase 2, Open-label, Multicenter Study of TL-895 in Subjects With Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis and Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis

Trial summary:

This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis

Receptor status / problem studied:

Myelofibrosis

Inclusion criteria

  • Adults ≥18 years of age
  • Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria
  • Palpable spleen measuring ≥5 cm below the LLCM or spleen volume of ≥450 cm3 by MRI or CT scan assessment
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
  • Adequate hematologic, hepatic, and renal functions

Exclusion criteria

  • Prior treatment with any BCR-ABL, phosphoinositide 3-kinase (PI3K), mammalian target of rapamycin (mTOR), bromodomain and extraterminal domain (BET) or spleen tyrosine kinase (Syk) inhibitors
  • Cohorts 1 and 2 – Prior treatment with JAKi within 21 days of the Screening MRI/CT scan. Subjects in Cohort 3 must not have received JAKi
  • Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment

View more trial information

Recruitment completed

Trial Title

TL-895-201

Diagnosis

Myeloproliferative disorders

Type of trial

Pharmaceutical

Type of treatement

Haematology

Phase

II

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