An Open-label, Uncontrolled, Phase I Dose Escalation Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in Patients With Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL
• Patients with histopathologically confirmed diagnosis of one of the following subtypes as defined by the 2017 revision of the WHO classification of lymphoid malignancies:
• Peripheral T-cell lymphoma(PTCL)
⁃ Angioimmunoblastic T-cell lymphoma(AITL)
⁃ Peripheral T-cell lymphoma, NOS(PTCL-NOS)
⁃ Nodal peripheral T-cell lymphoma with TFH phenotype(nodal PTCL with TFH)
⁃ Follicular T-cell lymphoma(FTCL) Cutaneous T-cell lymphoma(CTCL)
⁃ Mycosis fungoides(MF)
⁃ Sezary syndrome Chronic lymphocytic leukemia/small lymphocytic lymphoma(CLL/SLL)
• Relapsed or refractory patients with tumors for which no established standard therapy is available, or refractory or intolerant to existing standard therapy judged by principal investigator or subinvestigator
• ECOG PS 0\
‣ 2
• Life expectancy of at least 3 months