This is an international, multicenter, multi-arm, phase Ib, model-based dose-escalation
study. The primary objectives of the study in each arm is to determine the maximum tolerated
dose (MTD), recommended phase 2 dose (RP2D), dose limiting toxicities (DLTs) and to evaluate
the clinical efficacy at the MTD of various combinations of pembrolizumab, pralatrexate and
The peripheral T-cell lymphomas (PTCLs) are rare subtypes of Non-Hodgkin lymphoma (NHL) with
unique clinicopathologic features and very unfavorable prognosis. Recently it has been
demonstrated that PTCLs are characterized by recurrent mutations in epigenetic operators
(e.g. TET2, DNMT3A, and IDH2) and escape from immune surveillance.
The safety and toxicity of these combinations will be evaluated throughout the entire study.
Dose allocation in Arms A and C will be based upon a continual reassessment method (CRM), and
combination allocation in Arm B will be conducted using a DLT-adapted partial order continual
reassessment method (POCRM) for dose-finding with combinations of agents.
Study Hypothesis: If pralatrexate and/or decitabine functions in an immunomodulatory fashion
then priming and modulating the malignant cells and the microenvironment will enhance the
antitumor activity of pembrolizumab in patients with PTCLs and CTCLs.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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