PTCL Clinical Trial
Official title:
Novel Immuno-epigenetic Based Platform for Patients With Peripheral T-cell Lymphoma (PTCL) and Cutaneous T-cell Lymphoma (CTCL): an International Phase Ib Study of Pembrolizumab Combined With Decitabine and/or Pralatrexate
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.
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. ;
| 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| Withdrawn |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
|