Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas

NCT03598998 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-06-26

Study results available
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Summary

This phase I/II trial studies the side effects and best dose of pralatrexate when given together with pembrolizumab and how well they work in treating patients with peripheral T-cell lymphomas that has come back after a period of improvement or has not responded to treatment. Pralatrexate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab and pralatrexate may work better in treating patients with peripheral T-cell lymphomas.

Conditions

  • Anaplastic Large Cell Lymphoma
  • Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
  • Recurrent Anaplastic Large Cell Lymphoma
  • Recurrent Angioimmunoblastic T-Cell Lymphoma
  • Recurrent Enteropathy-Associated T-Cell Lymphoma
  • Recurrent Follicular Lymphoma
  • Recurrent Hepatosplenic T-Cell Lymphoma
  • Recurrent Mature T- Cell and NK-Cell Non-Hodgkin Lymphoma
  • Recurrent Monomorphic Epitheliotropic Intestinal T-cell Lymphoma
  • Recurrent Mycosis Fungoides
  • Recurrent Peripheral T-Cell Lymphoma, Not Otherwise Specified
  • Refractory Anaplastic Large Cell Lymphoma
  • Refractory Angioimmunoblastic T-Cell Lymphoma
  • Refractory Enteropathy-Associated T-Cell Lymphoma
  • Refractory Follicular Lymphoma
  • Refractory Hepatosplenic T-Cell Lymphoma
  • Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
  • Refractory Mycosis Fungoides
  • Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified
  • Subcutaneous Panniculitis-Like T-Cell Lymphoma

Interventions

BIOLOGICAL

Pembrolizumab

Given IV

DRUG

Pralatrexate

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Alex F Herrera · City of Hope Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-04
Primary Completion
2023-05-03
Completion
2026-02-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03598998 on ClinicalTrials.gov