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Clinical Trial Summary

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 decitabine.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03240211
Study type Interventional
Source University of Virginia
Contact Marian Abdelmalek, MSc
Phone 434-924-8827
Email mka6s@virginia.edu
Status Recruiting
Phase Phase 1
Start date February 2, 2022
Completion date December 31, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT03900442 - Phase 1 Study of PTX-100 in Patients With Advanced Malignancies With PTCL Expansion Cohort Phase 1
Withdrawn NCT02757248 - Ph1 Volasertib Plus Romidepsin in R/R PTCL and CTCL Phase 1
Not yet recruiting NCT05238064 - Parsaclisib in Combination With CHOP in Participants With Previously Untreated PTCL Phase 1/Phase 2
Recruiting NCT04747236 - Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL Phase 2
Not yet recruiting NCT04705090 - A Study of YY-20394 in Patients With Relapsed or Refractory Peripheral T/NK Cell Lymphoma Phase 2
Completed NCT03493451 - Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms Phase 2
Recruiting NCT05967949 - A Retrospective Clinical Study on the First-line Maintenance Treatment of PTCL With Chidamide.
Recruiting NCT03884205 - GDPE/CEOPE Compared With CEOPE for Newly Diagnosed Patients With PTCL