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.1 个研究点目标入组 120 人开始时间: 待定最近更新: 2024年2月27日

试验速览

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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

efficacy -ORR

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发起方

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