A Multi-Center, Phase 2, Open-label, Parallel Cohort Study of Efficacy and Safety of Duvelisib in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

Secura Bio, Inc.0 个研究点目标入组 120 人开始时间: 2020年1月21日最近更新: 2024年5月27日

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•Pathologically-confirmed PTCL, as defined by the World Health Organization. Slides must be submitted for central pathology review. Results of central pathology review are not required prior to initiation of treatment.
•-Received at least 2 cycles of one standard regimen for newly diagnosed advanced PTCL, and one of the following:
•(a) failed to achieve at least a partial response after 2 or more cycles of standard therapy;
•(b) failed to achieve a complete response after completion of standard therapy; and/or
•(c) persistent or progressive disease after an initial response
•-For patients with CD30+ ALCL, failed or are ineligible or intolerant to brentuximab vedotin
•-Measurable disease as defined by Lugano for PTCL, i.e., at least 1 measurable disease lesion > 1.5 cm in at least one dimension by conventional techniques (18FDG-PET-CT, CT with contrast, MRI)

•-Primary leukemic PTCL subtypes (i.e., T-cell prolymphocytic leukemia, T-cell large granular lymphocytic leukemia, adult T-cell leukemia/lymphoma and aggressive NK-cell leukemia) or transformed mycosis fungoides
•-Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor
•-Known central nervous system involvement by PTCL
•-Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids > 20 mg of prednisone (or equivalent) once daily (QD)
•-Ongoing treatment for systemic bacterial, fungal, or viral infection at Screening

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